Precision medicine company Lucence and precision engineering company Akribis Systems today announced a technology collaboration to scale up accurate mass-testing for COVID-19.
 
The collaboration will develop an automated saliva solubilization instrument to enable mass-processing of saliva for accurate molecular PCR diagnostic testing by laboratories.
 
Saliva is the ideal sample for mass-testing as compared to invasive swabs1, because it is accurate, easier to collect, and risks of infection through aerosol are reduced for healthcare workers during specimen collection. COVID-19 saliva mass-testing has been adopted by the United States, Hong Kong SAR, Japan, and Australian governments. Saliva solubilization is a key step to allow saliva to be effectively tested.

In the laboratory, however, saliva solubilization is manual, heterogeneous and can even be physically painful and injurious for medical laboratory staff because of repeated stress injury from sample shaking requirements. Diverse lab practices to solubilizing saliva samples, or even worse, the omission of this step, can lead to reduced test accuracy.
 
Nearly 5 million COVID-19 tests are done daily worldwide2-4. This automated instrument platform will support medical laboratories worldwide, including within Singapore and Hong Kong SAR, to support the workflow of the SAFER™ Sample saliva collection kit by Lucence. The instrument ensures a standard and robust saliva solubilization protocol for saliva samples collected with the SAFER™ Sample kit to optimize accuracy over current manual approaches. Also, the instrument significantly reduces labor, discomfort, the time required by medical lab technicians while ensuring ease of scaling up for mass testing and screening of large populations.
 
The SAFER™ Sample Collection Kit is registered as a Class A medical device with the Health Sciences Authority of Singapore and is an easy-to-use saliva collection kit that enables accessible, non-invasive, and safe sample collection via saliva. It inactivates collected virus within 45 seconds5, thus achieving greater safety during transport for the community and the laboratory.
 
Together with the automated processing instrument, Lucence and Akribis aim to integrate precision medicine with precision engineering to solve a crucial saliva pre-processing step to maximize the accuracy of the COVID-19 test. This collaborative effort would help to link the accessibility of the SAFER™ Sample collection approach to mass testing in service laboratories, which is critical to scaling cost-effective testing worldwide for airports, borders, and population testing.

In a pilot study, Lucence and Akribis demonstrated the potential reduction of a medical lab technician’s hands-on time from 30 min to less than 5 min.

Dr. Tan Min-Han, Founder, CEO, and Medical Director of Lucence said: “Mass-testing is a key to restoring our economy, and strong automation approaches are required to support scaling up of saliva mass-testing solutions. Akribis is a global precision engineering company, and we’re proud to work with Akribis as our partner to solve a little-recognized but crucial bottleneck – saliva solubilization – to achieve accurate mass-testing results for the world.”

Mr. Leow Yong Peng, Founder, and CEO of Akribis said, “Great technology solutions emerge out of cross-disciplinary collaborations, and nowhere more so that between medicine and engineering. We’re proud to work together with Lucence, a global precision medicine company, to deliver an automated COVID-19 sample processing platform during a time of great need.”

Lucence and Akribis will be deploying the first unit by the end of July 2020.

About Lucence

Lucence is a precision oncology company that makes state-of-the-art, highly sensitive liquid biopsy tests for disease detection and treatment selection. Lucence is headquartered in Palo Alto and Singapore, and its services are delivered worldwide through an accredited central laboratory. Visit www.lucence.com for more information.

About Akribis Systems

Akribis is a precision engineering company that design and manufacture state-of-the-art direct drive motors, stages and precision systems for manufacturing, inspection and testing, and support a wide range of industries including semiconductor, solar, flat panel, hard disk, LED, printed circuit board, printing, photonics, and biomedical manufacturing, etc. Akribis is headquartered in Singapore, with two production factories in Singapore and Shanghai & Nantong, China, with worldwide sales and support offices in USA, South Korea, Japan, Thailand, Malaysia, Germany and Israel, and distribution channels in Asia, Europe and North America. Visit http://www.akribis-sys.com/ for more information

References

1. Azzi et al. Saliva is a reliable tool to detect SARS-CoV-2. J Infect. 2020 Jul;81(1):e45-e50. doi: 10.1016/j.jinf.2020.04.005.

2. CGTN. (2020, Jun 24). China’s daily COVID-19 testing capacity hits 3.78 million. https://news.cgtn.com/news/2020-06-24/China-s-daily-COVID-19-testing-capacity-hits-3-78-million-RAa1yHsBYk/index.html

3. The COVID Tracking Project. (2020, Jun 30). US historical data. https://covidtracking.com/data/us-daily

4. Our World in Data. (2020, Jun 30). Daily COVID-19 tests. https://ourworldindata.org/grapher/full-list-covid-19-tests-per-day

5. Agence France-Presse. (2020, June 16). Lucence, A*STAR share study data showing SAFERTM Sample Saliva Collection Kit for Covid-19 inactivates collected virus. https://www.afp.com/en/news/1313/lucence-astar-share-study-data-showing-safertm-sample-saliva-collection-kit-covid-19-inactivates-collected-virus-202006160053201

https://www.businesswire.com/news/home/20200616005320/en/Lucence-A*STAR-Share-Study-Data-Showing-SAFER%E2%84%A2

CHICAGO–(BUSINESS WIRE)–Coinciding with ASCO20, precision oncology company Lucence will be presenting data this week demonstrating high sensitivity of its liquid biopsy technology in detecting clinically relevant biomarkers in lung cancer, alongside promising data in breast and blood cancers. The data, presented as part of ASCO’s Virtual Scientific Program, show the Company’s AmpliMARK technology detection capability for recommended biomarkers with 97.4% concordance between two orthogonal liquid biopsy platforms in lung cancer. The Company is planning to make its LiquidHALLMARK test, powered by AmpliMARK, commercially available in the United States later this year for biomarker detection in lung cancer patients.

Clinical utility of a liquid biopsy diagnostic approach in lung cancer using amplicon-based next-generation sequencing in parallel with allele-specific PCR presents data from a multinational study examining real-world diagnostic outcomes of Lucence’s liquid biopsy technology in 374 lung cancer patients. Patients who were tested with an innovative combination of two blood-based liquid biopsy platforms achieved a one-day result for a key treatment decision, together with a subsequent comprehensive analysis of recommended markers, with a 97.4% concordance between the two platforms. This study highlights that ultrasensitive blood-based liquid biopsy is a key platform to support lung cancer diagnosis and appropriate treatment selection.

Ultrasensitive multiplex detection of structural rearrangements in ALK, RET, ROS1 and PD-L1 using a comprehensive next-generation sequencing assay, #302, will be presented on Friday, May 29th from 8:00-11:00 am Eastern Time in a virtual session. This poster reports AmpliMARK’s high sensitivity in detecting cancer-related structural variants in cfDNA samples from lung cancer patients, cfDNA samples from lymphoma patients, and tumor tissue DNA samples from natural killer(NK)/T-cell lymphoma patients. A second poster, Detection of actionable gene mutations in breast cancer by amplicon-based next-generation sequencing liquid biopsy, #120, reports AmpliMARK’s high sensitivity in detecting key PIK3CAESR1 and other driver gene mutations non-invasively in plasma cfDNA of breast cancer patients in a multinational study.

These new studies suggest that the LiquidHALLMARK liquid biopsy test, powered by amplicon-based sequencing technology AmpliMARK, has the potential to shift the paradigm in precision oncology. LiquidHALLMARK offers highly sensitive, target-rich insights into established biomarkers spanning 80 gene mutations and 10 gene fusions in 15 cancer types (available in the United States starting Q3 2020 for investigational use only). The data showcase AmpliMARK’s excellent performance in rapidly detecting multiple somatic variants, highlighting the technology’s potential to deliver fast insights for clinicians to develop the most effective treatment plans for patients.

To adapt to the virtual format of ASCO20, Lucence has created an online hub at lucence.com/asco2020. Attendees can book a meeting with the Lucence team, see a complete list of posters and abstracts, and register for a webinar on COVID-19 and lung cancer presented by the Singapore Society of Oncology, taking place on June 4th, 2020 at 5 PM Pacific Time/8 PM Eastern Time and June 5th at 8 AM GMT+8.

About Lucence

Lucence is a precision oncology company that makes state-of-the-art, highly sensitive liquid biopsy tests for disease detection and treatment selection. Lucence’s flagship test, LiquidHALLMARKTM is swift, simple, and sensitive. Powered by AmpliMARKTM, the Company’s proprietary amplicon-based sequencing technology, LiquidHALLMARKTM covers a wide range of clinically relevant biomarkers, including mutations in 80 genes, fusions in 10 genes, and somatic variants in 15 cancer types. Lucence is headquartered in Palo Alto and Singapore, and its services are delivered worldwide through an accredited central laboratory. Visit www.lucence.com for more information.

SINGAPORE, 20 March 2020 – Molecular diagnostics company Lucence announced today the development of the SAFER-Sample (Stabilization of nucleic Acid Formulation for Evaluation of RNA) kit, a sample collection medical device to facilitate more accessible testing of viral infections such as COVID-19.

Presently, definitive diagnosis of RNA viral infections such as COVID-19 requires patients with respiratory infections to undergo nose and/or throat swabs, and it is recommended that these samples are transported with chilled media. However, chilled transport media is not universally available and subject to worldwide shortages, leading to the risk of compromised testing because of specimen drying, contamination or degradation, especially if transported at room temperature. Among other factors, accurate diagnostic testing depends on sampling quality, storage and transport to the testing laboratory.

The SAFER-Sample medical device is a collection kit that comes with a bottle of stabilization fluid to be mixed with the sample at the point of collection, keeping viral RNA stable at room temperature for up to one week. The sample can then be transported to a testing lab without the need for chilling, especially useful in countries where samples must be transported across large geographical areas for testing.

Dr. Tan Min-Han, Founding CEO of Lucence and Adjunct Clinician-Scientist at the Institute of Bioengineering and Nanotechnology (IBN) of A*STAR said, “We are very glad that our technology, used to reduce suffering of cancer patients, can contribute to accurate testing solutions during this global crisis.  In line with our mission of using molecular technology to improve health worldwide, we are making up to 10,000 kits available at no cost to the scientific community.”

The reagent used in the SAFER-Sample kit was invented at the Institute of Bioengineering and Nanotechnology of A*STAR, the Agency for Science, Technology and Research of Singapore. Experiments demonstrate that SAFER-Sample allows for better stabilization of the genomes of RNA viruses, versus other types of specimen transport media at room temperature, to facilitate more accurate testing.

Additional evaluation of SAFER-Sample’s ability to inactivate COVID-19 at collection is in progress to understand the kit’s ability to improve the safety of healthcare workers while they collect and process patient samples. With Lucence’s expertise in non-invasive ultrasensitive molecular testing technology, and the productizing capabilities of the Diagnostics Development (DxD) Hub, SAFER-Sample kit can also be used for non-invasive sample types including saliva.  DxD Hub is a national initiative led by A*ccelerate, the commercialization arm of Singapore’s Agency for Science, Technology and Research.

Dr. Sidney Yee, CEO of DxD Hub said “We’re excited that this collaboration can result in more accessible testing of RNA viruses. Such public-private partnerships are especially important in times like these, where the translation of innovation in the labs to rapidly fulfill the demands of the healthcare community is critical.”

The National Centre for Infectious Diseases (NCID) Singapore is currently evaluating non-invasive patient specimens collected with the SAFER-Sample reagent, and Lucence is working with the Ministry of Health Singapore for broader performance evaluation. The SAFER-Sample kit has been registered with the Health Sciences Authority (HSA) as a Class A medical device.

A/Prof Hsu Li Yang, Program Leader in Infectious Diseases, Saw Swee Hock School of Public Health at the National University of Singapore (NUS), and Adjunct Clinician-Scientist at IBN, said, “This innovation comes at a time when primary care and community testing of COVID-19 is becoming an urgent need. Public-private partnerships that result in these breakthroughs are critical for delivering necessary resources in areas that either are unable to achieve alone.”

 

MIAMI, FL—Singapore-based precision oncology startup Lucence, on the heels of its series A funding, is sharing early data highlighting the capabilities of its liquid biopsy technology to detect somatic variants in patients with blood cancers, with excellent matching between bone marrow and blood. Lucence’s amplicon-based sequencing technology, known as AmpliMARK™, can provide high sensitivity mutation detection in blood for multiple solid tumor types. This new study data demonstrates the performance of AmpliMARK™ in hematological malignancies, and suggests that it can provide high resolution, target-rich insights for clinicians and patients to better, and less invasively, manage these diseases.

Liquid biopsy aims to use blood as a platform for cancer screening, diagnosis, treatment, and monitoring. In the case of hematological malignancies like leukemia, current bone marrow-based tests for detecting and monitoring disease progression offer limited sensitivity and are highly invasive.  Lucence’s findings suggest that a blood-based liquid biopsy test could be a compelling, highly sensitive clinical alternative to these tests.

Lucence’s poster highlighting their recent study results, Ultrasensitive Detection of Diverse Genomic Alterations in Hematological Malignancies using a Targeted Amplicon-based Sequencing Approach, will be presented Tuesday, January 14th at 4:15 pm Eastern Time at the American Association for Cancer Research Advances in Liquid Biopsies meeting in Miami. Based on a study of 65 patients with hematological malignancies, including acute myeloid leukemia, myelodysplastic syndromes, and multiple myeloma, the poster reports high sensitivity of AmpliMARK™ in detecting genomic alterations in blood and bone marrow samples. The study results show that AmpliMARK™ detects mutations at a sensitivity down to 0.1% variant allelic frequencies (VAF) and fusion genes like BCR-ABL1 down to 1% VAF. The results also show excellent concordance between bone marrow and blood, suggesting blood could be a viable medium of detection when marrow is challenging to obtain.

AmpliMARK™ uses a unique molecular bar-code and error correction technology that improves test sensitivity across multiple mutation types for single nucleotide variants and fusion genes. AmpliMARK™ is the foundational breakthrough technology in Lucence’s offering of blood-based tests for both profiling hematological and solid tumors.

Dr. Zi Yi Lim, senior consultant haematologist at the Centre for Clinical Haematology and study co-author, said, “Molecular diagnostics are an essential part of the workup and an important follow up tool in patients with blood cancers. Bone marrow assessments remain the gold standard investigation to evaluate the genomic disease profile of these patients. However, bone marrow assessments are costly, invasive and uncomfortable for the patient. The finding that Lucence’s technology can detect even low-level mutations in peripheral blood of patients with a high level of concordance to bone marrow is an exciting development. This could facilitate more convenient, cost-effective and regular disease assessments of such patients with a blood test.”

Lucence is currently preparing to open their Silicon Valley laboratory to make their liquid biopsy tests more widely available to US clinicians and patients.  While the Company’s initial focus in the US will be in profiling late-stage lung cancer patients for treatment selection, the data presented at the AACR conference provides early validation of the core technology of Lucence’s liquid biopsy tests. Lucence announced their $20 million Series A led by IHH Healthcare, one of the world’s largest integrated private healthcare groups, in November 2019, and their executive team will be attending the upcoming 38th Annual J.P. Morgan Healthcare Conference in San Francisco.

SINGAPORE, SINGAPORE November 20, 2019—Lucence, a genomic medicine company that invents blood-based tests for cancer screening and treatment selection, announced today the close of USD $20 million in Series A funding. The round was led by IHH Healthcare, one of the world’s largest integrated private healthcare groups. SGInnovate, together with existing investors Temasek Holdings subsidiary Heliconia Capital, Lim Kaling, Koh Boon Hwee and others, also participated in the round. This funding will enable the company to provide its liquid biopsy technology to more patients across Asia and North America for personalized treatment selection. Lucence will also embark on new prospective clinical studies to evaluate its technology for the early detection of multiple cancers.

Lucence spun out of Singapore’s Agency for Science, Technology and Research (A*STAR) in 2016. In 2018, the company introduced its flagship next-generation sequencing test, LiquidHALLMARK®, the first and only clinical sequencing blood test that detects both cancer-related gene mutations and cancer-causing viruses within a single assay. The test has been used by oncologists in cancer diagnosis, monitoring and treatment selection for over 1,000 patients in Asia to date. LiquidHALLMARK® detects clinically relevant mutations across 14 cancer types, including lung, breast, colorectal, pancreatic, nasopharyngeal and liver cancers. The test is based on Lucence’s core molecular watermarking technology, AmpliMARK™, for improved accuracy and depth in sequencing results. In 2019, Lucence’s Singapore central laboratory became the first laboratory in Southeast Asia to be CLIA-certified and CAP-accredited in order to bring LiquidHALLMARK® to physicians and patients in the United States.

“Our mission is to reduce worldwide suffering through early cancer detection. As a medical oncologist, I have worked in the clinic and the laboratory for over a decade, striving towards a world where cancer can be overcome with early screening. Our research discoveries, such as the identification of the circulating tumor-endothelial cluster, can transform the liquid biopsy field, allowing better non-invasive cancer screening and profiling for patients. This partnership with IHH Healthcare will accelerate our work to achieve early cancer detection and effective cures, and expand access to this much-needed liquid biopsy technology to patients across Asia and the United States,” said Dr. Min-Han Tan, MBBS, PhD, founder and CEO of Lucence.

Dr. Kelvin Loh, Chief Executive Officer (Designate) of IHH Healthcare, said, “Liquid biopsy is a game-changer in our endeavor to provide cancer patients with better, value-driven outcomes through precise treatment selections and more affordable care. Our investment in Lucence will provide IHH patients with better access to this advanced technology. IHH looks to drive greater synergies with Lucence and co-develop solutions for patients, as well as explore opportunities to sharpen our precision medicine capabilities with other like-minded partners across our 10-country network.”

Lucence will be in attendance at the European Society of Medical Oncology (ESMO) Asia Congress this week and will be exhibiting at booth B09.

International precision medicine firm Lucence Diagnostics announced today that it has received the Clinical Laboratory Improvement Amendments (CLIA) certification for its laboratory in Singapore from the U.S. Department of Health and Human Services’ Centers for Medicare & Medicaid Services.

With this U.S. federal certification, Lucence can now receive patient specimens from the U.S. for testing with its LiquidHALLMARK®, its flagship liquid biopsy blood test that simultaneously detects cancer-causing gene mutations and viruses present in 14 types of cancers.

Dr. Min-Han Tan, CEO and founder of Lucence, said, “This is a critical regulatory and commercial milestone for Lucence. We are proud to be the first regional laboratory in Southeast Asia to demonstrate compliance with U.S. federal regulatory standards, over and above our CAP and ISO 15189 Accreditations. We are glad to serve American doctors with our technological innovation in liquid biopsy.”

These three internationally recognized credentials (CLIA, CAP and ISO15189) attest to Lucence’s compliance with the most comprehensive, rigorous and scientifically-endorsed standards of laboratory practice and underscore the company’s commitment to the highest global quality of cancer diagnostic services.

Singapore, 12 March 2019 – Lucence Diagnostics, a genomic medicine company focused on personalizing cancer care, today announced a new project to develop AI algorithms for improving diagnosis and treatment of liver cancer. The goal is to combine the imaging and molecular data from liver cancer patients into smarter software tools that help physicians make better treatment decisions.

Lucence will be working with Olivier Gevaert, PhD, Assistant Professor of Medicine (Biomedical Informatics) and of Biomedical Data Science at the Stanford University School of Medicine. Having developed LiquidHALLMARK®, the world’s first liquid biopsy next-generation sequencing test that analyzes the DNA of cancer-causing mutations and viruses, Lucence will contribute its genomics expertise and proprietary sequencing technology to this project.

Liver cancer is the second leading cause of avoidable cancer deaths globally[1], and hepatitis viruses contribute to the bulk of this disease. The incidence rate of liver cancer is also rising faster than any other cancer in both men and women in the United States[2].  The best chance of cure is surgery, and good characterization of the extent and type of the disease is critical for surgical planning. Imaging tests such as ultrasound, computed tomography (CT) and magnetic resonance imaging (MRI) play a crucial role in the visualization of liver tumors. Fusing imaging data with sequencing data that includes both cancer mutations and viral DNA will create a unique opportunity for AI-based approaches to advance liver cancer care.

This project will evaluate a dataset of over 5,000 patients to identify image changes and patterns that are linked to diagnostic and treatment outcomes in liver cancer.

“Lucence is excited to advance the field of medical imaging to guide liver cancer treatment. This is important because liver cancer is a major global threat, and is the only cancer rising in incidence and deaths in the United States. By combining radiology with our proprietary sequencing technology and track record in liver cancer data modelling, our AI algorithms will assist physicians in making better treatment decisions,’’ said Dr Min-Han Tan, Founder and CEO of Lucence Diagnostics.

 

About Lucence Diagnostics

Lucence Diagnostics is a genomic medicine company founded to fulfil its vision of a world without avoidable cancer deaths. The company invents non-invasive blood tests that improve cancer detection and treatment selection. Lucence targets the most common cancers in Asia using its proprietary technology and AI platform. Lucence is headquartered in Singapore with offices in San Francisco and Hong Kong. Its services are delivered worldwide through an accredited central laboratory. For more information, please visit www.lucencedx.com.

 

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[1] Journal of Global Oncology, 2018, DOI: 10.1200/JGO.17.00190.
[2] CA: A Cancer Journal for Clinicians, 2019, DOI: 10.3322/caac.21551.

Singapore, February 15, 2019 – Immunotherapy drugs such as PD-L1 checkpoint inhibitors represent the front-line treatment for kidney cancer. But immunotherapy is expensive, benefits only a subset of patients and is futile in the majority of patients. Now, researchers from National Cancer Centre Singapore and Lucence Diagnostics have conducted a study using Lucence’s molecular test, CLEARScore™, to predict immunotherapy response for kidney cancer. The findings from this study will be presented at the 2019 American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU) held in San Francisco this week.

CLEARScore™ is a molecular test that predicts treatment response for kidney cancer. It is an algorithm involving eight genes in the tumor, which classifies kidney cancer by molecular type. This test has been used to successfully predict treatment response of kidney cancer patients to tyrosine kinase inhibitors, a type of targeted therapy. The results were published in 2015 in European Urology, the world’s top urology journal.

In this new study, CLEARScore™ was investigated in correlation with anti-PD-L1 inhibitors and immune cell markers in 36 kidney cancer patients. The results showed that the gene expression score of the eight genes correlated with immune cell infiltration and clinical response to anti-PD-L1 inhibitors in a subset of patients. This indicates that multigene score should be investigated as a biomarker to select patients who are likely to respond to immunotherapy. The study was conducted by National Cancer Centre Singapore and Lucence Diagnostics, in collaboration with the Diagnostics Development (DxD) Hub led by A*ccelerate (A*STAR), Singapore General Hospital and OncoCare Cancer Centre.

“Immunotherapy is a major breakthrough in our battle against kidney cancer. It is however expensive and may have side effects. Having a test that can distinguish whether a kidney cancer patient will or will not benefit from anti-PD-L1 immunotherapy would be of high clinical value. Such tests have not been previously reported, and CLEARScore™ is a promising and exciting advance towards more precise selection of cancer patients for treatment,’’ said Dr Ravindran Kanesvaran, Senior Consultant, Department of Medical Oncology, National Cancer Centre Singapore, who designed and led the study.

“This is the first study to report the correlation of a multigene score with immune phenotypes in kidney cancer. We are excited about the potential of using our CLEARScore™ test to help kidney cancer patients avoid futile treatments and prolong their lives. To further establish the clinical utility of this test for immunotherapy, we will be conducting a multinational study on a larger cohort of kidney cancer patients,’’ said Dr Yukti Choudhury, Chief Technology Officer, Lucence Diagnostics, who will be presenting the study at ASCO GU.

Kidney cancer is among the ten most common cancers in men and women across the world. In 2018, there were over 400,000 new cases of kidney cancer globally[1].

 

About National Cancer Centre Singapore

National Cancer Centre Singapore (NCCS) provides a holistic and multi-disciplinary approach to cancer treatment and patient care. We see close to 65 per cent of the public sector oncology cases, and they are benefiting from the sub-specialisation of our clinical oncologists.  NCCS is also accredited by the US-based Joint Commission International for its quality patient care and safety. To deliver among the best in cancer treatment and care, our clinicians work closely with our scientists who conduct robust cutting-edge clinical and translational research programmes which are internationally recognised. NCCS will also launch its Proton Beam Therapy programme at its new centre. NCCS strives to be a global leading cancer centre, and shares its expertise and knowledge by offering training to local and overseas medical professionals.
www.nccs.com.sg

About Lucence Diagnostics

Lucence Diagnostics is a genomic medicine company founded to fulfil its vision of a world without avoidable cancer deaths. The company invents non-invasive blood tests that improve cancer detection and treatment selection. Lucence targets the most common cancers in Asia using its proprietary technology and AI platform. Lucence is headquartered in Singapore with offices in San Francisco and Hong Kong. Its services are delivered worldwide through an accredited central laboratory.
www.lucencedx.com

About Diagnostics Development (DxD) Hub

DxD Hub is Singapore’s national initiative led by public innovation and enterprise office, A*ccelerate Technologies (formerly ETPL). DxD Hub’s mission is to fast-track the transformation of early-stage research into clinically validated diagnostic devices that are ready for market adoption.

About Singapore General Hospital

Singapore General Hospital, a member of Singapore Health Services, is the public sector’s flagship hospital. Established in 1821, SGH is Singapore’s largest acute tertiary hospital with 1,700 beds and national referral centre offering a comprehensive range of 39 clinical specialties on its campus. Every year, about 1 million Singaporeans benefit from medical care delivered by its 800 specialists. As an academic healthcare institution and the bedrock of medical education, SGH plays a key role in nurturing doctors, nurses and allied health professionals, and is committed to innovative translational and clinical research to provide the best care and outcomes to patients. www.sgh.com.sg

 

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 [1] GLOBOCAN 2018

Singapore, January 30, 2019 – Lucence Diagnostics today announced the opening of its new headquarters and molecular diagnostics laboratory in Singapore. The opening was officiated by Dr Koh Poh Koon, Senior Minister of State, Ministry of Trade and Industry.

Lucence invents blood tests for rapid and non-invasive cancer detection. The company is a spin-off from the Agency for Science, Technology and Research (A*STAR). It was set up in 2016 by founder and CEO Dr Tan Min-Han. Lucence’s mission is to reduce avoidable cancer deaths through early detection and better treatment selection. It focuses on the most common cancers in Asia, such as cancers of the breast, colon, liver, lung and nose.

Such cancer blood tests are referred to as a liquid biopsy. Conventional tissue biopsy requires the surgical removal of tissue from the body, which is invasive and slow. Lucence’s liquid biopsy tests are non-invasive, fast and affordable because it only requires one draw of blood.

Since its founding, Lucence has raised S$12.9 million in seed funding to deliver its liquid biopsy tests to patients in public and private healthcare institutions in Asia. Lucence has expanded its business operations to Hong Kong and San Francisco. Its blood tests are currently available in India, Hong Kong, Philippines, Malaysia, Myanmar, Thailand, Vietnam and Singapore. Lucence’s new 10,000 square feet facility will help the company scale up its R&D operations, meet the growing demand for its clinical services, and expand to new markets.

Today also marks the launch of Lucence’s latest flagship blood test LiquidHALLMARK®. This new test is able to detect 14 types of cancers, 50 genetic mutations and 2 viruses. It is the world’s first blood test that simultaneously detects both cancer-causing genetic mutations and viruses with 99.9% accuracy. This test delivers comprehensive molecular profiling of tumor with one draw of blood using Lucence’s proprietary amplicon-based sequencing technology AmpliMARK™. It detects DNA fragments from cancerous tumors that circulate in the blood to identify tumor-specific genetic mutations, as well as viruses like Hepatitis B, which is associated with liver cancer, and Epstein-Barr, which is associated with nose cancer.

LiquidHALLMARK® will help physicians select the right targeted therapies and immunotherapies for their patients. It will also match patients to clinical trials of new treatments that may help them. This treatment recommendation system is supported by Lucence’s artificial intelligence platform SunTzu.AI™, which integrates clinical data from diverse sources, to develop a personalized treatment strategy for each patient.

Lucence is now also developing a blood test for the early detection of multiple cancers to save lives. The company will launch a clinical study with 100,000 participants across Asia to validate its early cancer detection test this year.

“Lucence’s vision is to achieve zero avoidable cancer deaths through early detection and better treatment selection. Our expanded molecular diagnostics laboratory will be the foundation of that vision. We are glad to have improved the lives of thousands of patients in Asia with our range of blood tests for cancer screening and treatment selection. We will continue to innovate because we want to achieve early detection for all types of cancers to truly save lives,” said Dr. Tan Min-Han.

Speech by Dr. Koh Poh Koon, Senior Minister of State, Ministry of Trade and Industry.

 

About Lucence Diagnostics

Lucence Diagnostics is a genomic medicine company founded to fulfil its vision of a world without avoidable cancer deaths. Lucence invents non-invasive blood tests that improve cancer detection and treatment selection. It targets the most common cancers in Asia using its proprietary technology and AI platform. Lucence is headquartered in Singapore with offices in San Francisco and Hong Kong. Its services are delivered worldwide through an accredited central laboratory. For more information, please visit www.lucencedx.com.

Media Contact

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Singapore, 23 November 2018 – Lucence Diagnostics, a genomic medicine company focused on personalizing cancer care, and iGenetic Diagnostics, a leading pathology company with operations across India, today announced a partnership to distribute Lucence’s liquid biopsy tests for early cancer detection and treatment in India.

iGenetic will be distributing Lucence’s flagship liquid biopsy test – LiquidHALLMARK®, the world’s first blood test to span multiple cancer-causing mutations and viruses. This test improves cancer diagnosis and treatment selection for patients with advanced cancer. The blood test analyzes the cancer-driving mutations from the DNA shed by the tumor into the bloodstream to determine the best available treatment, which include targeted therapy and immunotherapy.

LiquidHALLMARK® targets a wide range of cancers, especially the cancer types that are most prevalent in Asia, like lung, colon and breast cancers. The turnaround time for this test is also shorter with results coming back in days instead of over a week for current approaches. The test is based on Lucence’s proprietary molecular watermarking technology AmpliMARK™ with sensitivity and specificity of up to 99.9%, which is supported by its AI-powered clinical analytics engine SunTzu.AI™.

iGenetic specialises in providing the full spectrum of pathology solutions including molecular diagnostic services that deliver quicker and accurate results for its customers. The company is headquartered in Mumbai with seven processing labs and over 20 collection centres across India.

“Delivering advanced molecular diagnostics that can enable a quick and precise diagnosis will help to save lives. We are excited to collaborate with Lucence to deliver their proprietary liquid biopsy tests for early cancer detection and better treatment selection to patients in India. Lucence’s technology will help doctors personalize treatment for their patients and improve patient outcomes,’’ said Arunima Patel, CEO, iGenetic Diagnostics.

“Lucence is delighted to collaborate with iGenetic to launch our liquid biopsy tests in India. We are focused on reducing avoidable cancer deaths, particularly in Asia, where more than 4 million cancer deaths occur annually. With iGenetic’s experience and presence in India, we are confident that this partnership will drive better cancer care in India’’, said Dr. Min-Han Tan, Founder and CEO, Lucence Diagnostics.

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About Lucence Diagnostics

 Lucence Diagnostics is a genomic medicine company founded to achieve the vision of a world without avoidable cancer deaths. The company is headquartered in Singapore with offices in Hong Kong and San Francisco. Lucence invents genome-based diagnostic tests that enable innovative early cancer detection and treatment selection. Lucence targets the most common cancers in Asia using its proprietary technology and AI-driven genome intelligence. Its key operations are serviced worldwide through an accredited central laboratory. For more information, please visit www.lucencedx.com.

About iGenetic Diagnostics

iGenetic is a next generation diagnostics company focused on the full range of pathological investigations, including specialized cytogenetic and molecular tests in oncology, critical care, gynaecology and neurology. The company is headquartered in Mumbai and operates an accredited central laboratory and a network of labs and collection centres across India. The company has a test menu of over 1400 investigations and is focused on introducing advanced technologies for the Indian population. For more information, please visit www.igenetic.com.

Singapore, 30 October 2018 – Lucence Diagnostics today announced the launch of the world’s first molecular test to distinguish breast fibroadenoma, the commonest benign breast tumor, from phyllodes tumor, a less common tumor that may be malignant. Both fibroadenomas and phyllodes tumors are classified as fibroepithelial tumors. This test will help doctors decide how to treat an indeterminate fibroepithelial breast lump that has been detected. The FibroPhyllo™ Tissue test is based on a technology invented by the Singapore General Hospital (SGH) and the Agency for Science, Technology and Research (A*STAR).

Fibroadenoma is the most common benign breast tumor in the world. Around 1 in 10 women will develop a fibroadenoma in their lifetime[1]. In the United States, nearly one million fibroadenomas are diagnosed each year[2],[3]. It typically requires no treatment or the surgical removal of only the tumor. Phyllodes tumor is a less common tumor, a small percentage of which can be malignant; it may recur even after being removed. International guidelines recommend the surgical removal of both the phyllodes tumor and its surrounding healthy breast tissue.

It can be challenging to differentiate the two types of breast tumors because they share overlapping clinical and histological features. Current immunohistochemical techniques are also subjective and open to interpretation.  As the prudent approach for indeterminate cases discovered on core biopsy is to treat such cases as potentially malignant, this can result in the unnecessary removal of healthy breast tissue for women.

Lucence’s new FibroPhyllo™ Tissue test addresses this problem by being able to distinguish whether an indeterminate fibroepithelial breast lump is a fibroadenoma or a phyllodes tumor on core biopsy material. The technology that underpins the test was developed over five years by a research team led by Professor Tan Puay Hoon, Chairman, Division of Pathology and Senior Consultant at SGH and Dr Tan Min-Han, then Principal Investigator at A*STAR and currently Founder and CEO of Lucence Diagnostics.

The team identified five genes with different biological functions using machine learning and found that the expression levels of these five genes could accurately distinguish between the two types of breast tumors. The FibroPhyllo™ Tissue test was validated in a cohort study of 230 breast fibroepithelial tumor tissue samples. The test was able to differentiate fibroadenomas from phyllodes tumors with an accuracy of 93%. Their findings were published in the leading journal Breast Cancer Research in 2016.

Lucence Diagnostics, an A*STAR spin-off, subsequently obtained the technology from A*STAR through its commercialization arm ETPL for development as a clinical assay globally.

“The development of a molecular test that can assist in differentiating an indeterminate fibroepithelial tumor into a fibroadenoma or a phyllodes tumor reflects the commitment to research and development at the Singapore General Hospital. This research collaboration will result in faster and more effective treatment for patients. Over 9,000 women were diagnosed with breast diseases in Singapore in the past 5 years. We aim to advance breast diseases research to save more lives,” said Prof Tan Puay Hoon.

Dr Tan Min-Han said, “With the FibroPhyllo™ Tissue test, there is now objective guidance for management of the most common breast tumors that women may develop. We are excited to launch a test that has been shown to improve the diagnosis of breast fibroepithelial tumors. Lucence is fully dedicated to delivering better healthcare for women worldwide. This molecular test will help raise global standards of breast health, by making clear to doctors when surgery is needed and avoiding the unnecessary removal of healthy breast tissue.”

“The availability of the FibroPhyllo™ Tissue test to guide clinicians in surgical decision-making today, is an encouraging result of concerted efforts between public and private sector research,” said Mr Philip Lim, CEO, ETPL, A*STAR. “We are proud to have worked with Lucence from its early days to bring the idea for this test from the lab to the market, for the benefit of patients worldwide,” he added.

The FibroPhyllo™ Tissue test was launched today to mark Breast Cancer Awareness Month in October. Breast cancer is the most common cancer and the leading cause of death among women worldwide. According to the Singapore Cancer Registry, breast cancer accounts for about 30 per cent of all cancers among women in Singapore.

The FibroPhyllo™ Tissue test is now available in Singapore, Hong Kong and ASEAN.

About Lucence Diagnostics

Lucence Diagnostics is a genomic medicine company focused on personalizing cancer care. Headquartered in Singapore with offices in San Francisco and Hong Kong, Lucence invents genomic-based diagnostic tests that enable cancer screening and treatment selection. Lucence’s tests target the most common cancers in Asia using proprietary technology and clinical analytics. Its key operations are supported by an ISO15189 accredited molecular diagnostics laboratory and a cancer genetics clinic. For more information, please visit www.lucencedx.com.

About Singapore General Hospital

Singapore General Hospital, a member of Singapore Health Services, is the public sector’s flagship hospital. Established in 1821, SGH is Singapore’s largest acute tertiary hospital with 1,700 beds and national referral center offering a comprehensive range of 39 clinical specialties on its campus. Every year, about 1 million Singaporeans benefit from medical care delivered by its 800 specialists. As an academic healthcare institution and the bedrock of medical education, SGH plays a key role in nurturing doctors, nurses and allied health professionals, and is committed to innovative translational and clinical research in her continual strive to provide the best care and outcomes to her patients. www.sgh.com.sg

About Pathology Academic Clinical Progamme (PATH ACP)

The SingHealth-DukeNUS Pathology Academic Clinical Programme comprises the Singapore General Hospital’s Division of Pathology, and the Pathology Departments of KK Women’s & Children’s Hospital (KKH), Changi General Hospital (CGH) and SengKang Hospital (SKH).  Continuous research and education to deliver cutting edge pathology services that support best patient care are pivotal to the Pathology Academic Clinical Programme.

About the Agency for Science, Technology and Research (A*STAR)

The Agency for Science, Technology and Research (A*STAR) is Singapore’s lead public sector agency that spearheads economic oriented research to advance scientific discovery and develop innovative technology. Through open innovation, we collaborate with our partners in both the public and private sectors to benefit society.

As a Science and Technology Organisation, A*STAR bridges the gap between academia and industry. Our research creates economic growth and jobs for Singapore, and enhances lives by contributing to societal benefits such as improving outcomes in healthcare, urban living, and sustainability.

We play a key role in nurturing and developing a diversity of talent and leaders in our Agency and research entities, the wider research community and industry. A*STAR’s R&D activities span biomedical sciences and physical sciences and engineering, with research entities primarily located in Biopolis and Fusionopolis.

For ongoing news, visit www.a-star.edu.sg.

Media Contact

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[1] A. Lakoma and E. S. Kim. Minimally Invasive Surgical Management of Benign Breast Lesions. Gland Surg. 2014; 3(2): 142-148.

[2] D. Grady. Study of Breast Biopsies Finds Surgery Used Too Extensively. February 18, 2011.

[3] R. Greenberg, Y. Skornick, O. Kaplan. Management of Breast Fibroadenomas. J Gen Intern Med 1998;13(9):640-5.

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