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Tumor Treatment

Tumor Treatment

Lucence tests are currently available outside the United States only.



LiquidHALLMARK®


Our flagship blood test that simultaneously detects cancer-causing gene mutations and viruses in multiple cancers to improve cancer diagnosis and treatment selection.

Cancer
Type
···
Sample
Type
···
Turnaround
Time
···
Multiple Cancers Blood 8 Days

A sensitive next-generation sequencing (NGS) liquid biopsy test covering a wide range of clinically-relevant companion biomarkers. LiquidHALLMARK® examines plasma circulating tumor DNA (ctDNA) mutations in 80 genes (available in the US starting Q3 2020 for investigational use only) , including fusions in 10 genes.

Powered by AmpliMARK, Lucence’s proprietary amplicon-based NGS, LiquidHALLMARK®  supports cancer diagnosis, treatment selection, and disease monitoring. The assay identifies somatic variants in 15 cancer types, including lung, breast and colon cancers.

Benefits:

  • SWIFT
    Quick turnaround in just 8 days
  • SIMPLE
    Non-invasive, just 1 blood draw.
  • SENSITIVE
    Performance independently reported and validated
  • COMPREHENSIVE
    Targets SNVs (including cis-trans), indels, CNVs, MSI, fusions, and viruses

Recommended for patients who:

  • Have advanced cancers, especially when tissue biopsy is insufficient or difficult
  • Have cancers of unknown primary origin
  • Will benefit from serial monitoring of treatment outcomes
Target List
Genes*
 ABL1  AKT  ALK#  APC  AR  ARAF
 ATM  BRAF  BRCA1#  BRCA2#  CCND1#  CCND2
 CTNNB1  CDH1  CDK6 CDKN2A CREBBP EGFR#
 ERBB2 (HER2)#  ERCC2  ESR1  EZH2  FBXW7#  FGFR1
FGFR2 FGFR3 FLT3 GATA3 GNA11 GNAQ
GNAS HNF1A HRAS IDH1 IDH2 JAK1
 JAK2 JAK3 KEAP1 KIT# KRAS# MAP2K1 (MEK1)
MAP2K2 MAPK1 (ERK2) MED12 MET# MLH1 MTOR
MYC# NF1 NFE2L2 NOTCH1 NRAS# NTRK1
NTRK3 PDGFRA# PIK3CA# PIK3R1 PPP2R1A PTEN#
PTPN11  RAF1  RB1  RET  RHEB RHOA 
 RIT1 ROS1 SF3B1   SMAD4^  SMO SPOP 
STK11  TERT promoter  TP53^  U2AF1  VHL
Fusions
ALK FGFR2 FGFR3 NTRK1 NTRK2 NTRK3
PD-L1 RET ROS1 TMPRSS2
MSI
BAT25 BAT26 NR21 NR24 NR27 MONO27
Viruses
EBV HBV HHV-8

* Targeted regions selected to maximize detection of known hotspot mutations. List available on request.
 Includes sequencing of EGFR mutations in exons 18-21 such as T790M and C797S.
# Detection of genetic variants and amplification.
^ Full coverage.

LiquidMARK


LiquidMARK™ are focused sub-panels for 15 specific cancer types, including breast, colon, and lung cancers.

Gene List
Tests Targets Turnaround Time
LiquidMARK™ Lung Genes*
ALK#, BRAF, EGFR#, ERBB2 (HER2)#, KRAS#, MET#, MTOR, NRAS#, NTRK1, NTRK3, PIK3CA#, PIK3R1, RET, ROS1, STK11, TP53^
Fusions
ALK, RET, ROS1, NTRK1,  NTRK2, NTRK3, PD-L1
MSI
BAT25, BAT26, NR21, NR24, NR27, MONO27
8 days
LiquidMARK™ Breast Genes*
AKT1, BRCA1#,  BRCA2#, CDH1, ERBB2 (HER2)#, ESR1, GATA3, MYC#, NTRK1, NTRK3, PIK3CA#, PIK3R1, PTEN#, RB1, TP53^
Fusions
NTRK1,  NTRK2, NTRK3, PD-L1
MSI
BAT25, BAT26, NR21, NR24, NR27, MONO27
8 days
LiquidMARK™ Colon Genes
APC, BRAF, ERBB2 (HER2)#, FBXW7#, JAK1, KRAS#, MTOR, MYC#, NRAS#, NTRK1, NTRK3, PIK3CA#, PIK3R1, RAF1, TP53^
Fusions
NTRK1,  NTRK2, NTRK3, PD-L1
MSI

BAT25, BAT26, NR21, NR24, NR27, MONO27
8 days

Click here to view the gene list of all our LiquidMARK™ tests.

* Targeted regions selected to maximize detection of known hotspot mutations. List available on request.
Includes sequencing of EGFR mutations in exons 18-21 such as T790M and C797S.
# Detection of genetic variants and amplification.
^ Full coverage.

References:
1. Choudhury, Y. et al. Ann. Oncol., 29, 2018 (suppl_9; mdy441.010).

LiquidSCREEN™ & LiquidTRACK


Blood tests that detect and track sensitizing and resistant mutations in EGFR

 

Cancer
Type
···
Sample
Type
···
Turnaround
Time
···
Lung Blood and
Cerebrospinal Fluid
2 Days

LiquidSCREEN™ and LiquidTRACK™ detect specific EGFR mutations from circulating tumor DNA in blood. The tests help physicians select targeted therapies and monitor treatment response based on the cancer-driving mutation. The tests provide quantitative results of the level of mutation present in blood, allowing for more accurate disease monitoring. The technology has been clinically validated in a multicentre Singapore study.

LiquidSCREEN™

  • Patient: Has not done liquid biopsy before
  • Objective: To detect sensitizing and resistant mutations
    for treatment selection

LiquidTRACK™

  • Patient: Has done LiquidSCREEN™ and identified
    the sensitizing and resistance mutation(s)
  • Objective: To monitor and detect resistance to
    treatment

Benefits:

  • Results ready in 2 working days for rapid decision making
  • Simple and non-invasive, only 1 blood draw
  • Ultrasensitive with detection limits of up to 0.01%

Recommended For:

  • Patients with advanced or late-stage cancers
  • Patients who may prefer non-invasive testing or are not suitable for invasive surgical procedure
  • Will benefit from serial monitoring of treatment outcomes
Gene List
Tests Genes Sequenced Turnaround Time
LiquidSCREEN™ Lung Exon 18: G719A, G719C, G719S
Exon 19: delE746-A750, delL747-P753insS, delL747-A750insP, delL747-T751
Exon 20: T790M
Exon 21: L858R, L861Q
2 days
LiquidTRACK™ Lung EGFR : Selected patient-matched sensitizing mutations such as T790M and C797S 2 days

Bundled EXPRESS Service

Combined for quick and comprehensive testing

LiquidSCREEN™ Lung

1 day (instead of 2 days)

LiquidMARK™ Lung

8 days


References:
1. Luo, J. et al. A Systematic Review and Meta-Analysis, Science Reports, 4: 6269, 2014.
2. Kobayashi, S. et al. The New English Journal of Medicine, 352(8):786-792, 2005.
3. Janne, PA. et al. The New English Journal of Medicine, 372(18), 1689-1699, 2015.
4. Shi, J. et al. Annals of Oncology, Volume 28, Issue suppl_5, 2017.

LumiBRCA™ & LumiTHERA


Companion diagnostic tests that detect specific genetic mutations in breast and ovarian cancers for targeted treatment with PARP inhibitors.

Cancer
Type
···
Sample
Type
···
Turnaround
Time
···
Breast and
Ovarian Cancers
Blood 2-3 Weeks

LumiBRCA™ and LumiTHERA™ are blood tests that detects BRCA and other genetic mutations associated with breast and ovarian cancers for targeted treatment.

In addition to our specialized sequencing, our tests also include multiplex ligation-dependent probe amplification (MLPA) screening. MLPA allows us to detect large genomic rearrangements in BRCA genes, which contributes 11-36% of all BRCA genetic variants. The tests will help physicians to decide whether a patient is suitable for an FDA-approved targeted therapy likes PARP inhibitors and immunotherapy.

What is the difference between
LumiBRCA™ and LumiTHERA™?

LumiBRCA™ tests for mutations involved in the homologous recombination (HR) DNA repair pathway, including the BRCA genes, to check if the patient is suitable for PARP inhibitor therapy.

LumiTHERA™ is an expanded version of LumiBRCA™ that includes the genes involved with the mismatch repair function to check if the patient is suitable for both PARP inhibitor therapy and immunotherapy.

Benefits:

  • Non-Invasive, one draw of blood for diagnosis
  • Complete coverage of entire coding sequences of BRCA1 and BRCA2
  • Close to 100% sensitivity and specificity

Recommended For:

  • Patients diagnosed with breast and/or ovarian cancers
GENES
LumiBRCA™
LumiTHERA™
ATM
BRCA1
BRCA2
BRIP1
CHEK2
EPCAM
MLH1
MSH2
MSH6
MUTYH
NBN
PALB2
PMS2
PTEN
RAD51C
RAD51D

References:
1. FDA grants accelerated approval to new treatment for advanced ovarian cancer (2016)
2. European Medicines Agency (2015)
3. Alsop, K. et al. J Clin Oncol. 30, 2654-2663, 2012
4. Moller, P. et al. Eur J Cancer, 43, 1713-1717, 2007 5. Zhang, S. et al. Gynecol. Oncol. 121, 353-357, 2011
5. Casilli et al. J Med Genet, 43(9):e49, 2006
6. Eccles, D. M. et al. Adv. Ther. 33, 129-150, 2016
7. Sluiter & Rensburg, Breast Cancer Res Treat. 125(2):325-49, 2011
8. AstraZeneca Press Release: Lynparza meets primary endpoint in Phase III trial in BRCA-mutated metastatic breast cancer (2017)

HemeMARK


In-depth genomic profiling of the patients' haematological malignancies that covers a range of myeloid and lymphoid neoplasms.

Cancer Type
···
Sample Type
···
Turnaround Time
···
Haematological
Malignancies
Blood and Bone Marrow 10 Days

HemeMARK™ is a next-generation sequencing (NGS) based assay that detects cancer-related gene mutations from blood or bone marrow to support diagnosis, treatment selection, and disease monitoring. This NGS test detects clinically relevant mutations in various types of hematological malignancies including leukemia, lymphoma, and myeloma. This test is based on Lucence’s core molecular watermarking technology AmpliMARK™.

Target List
Genes
ABL1  ASXL1  ATM BRAF BTK CALR
CBL CCND1 CCND3 CD79B CDKN2A CDKN2B
CEBPA CREBBP CSF3R DNMT3A EZH2 FBXW7
FGFR3 FLT3 HRAS ID3 IDH1  IDH2
IKZF1 JAK2 JAK3 KIT KRAS  MPL
MYC MYD88 NOTCH1 NPM1  NRAS  RUNX1
SETBP1 SF3B1 SRSF2 TCF3 TET2  TP53
U2AF1  
Fusion
BCR/ABL1
MSI
BAT25 BAT26 NR21 NR24 NR27 MONO27

Tissue500


A comprehensive test panel that analyses more than 500 genes

Cancer Type
···
Sample Type
···
Turnaround Time
···
All solid tumors FFPE Tumor Tissue 4 Weeks

Tissue500™ is a comprehensive genomic profiling test that detects clinically-relevant genomic alterations in more than 500 genes to identify suitable target therapies for personalized medicine. It is able to detect multiple classes of genomic alterations and provide the status of microsatellite instability and tumor mutational burden. Broad molecular profiling picks up unanticipated and rare driver mutations, defining individual tumors to inform physicians of unique genomic signatures for personalized medicine.

Click here for the full Tissue500™ gene list.

Benefits:

  • Analyses more than 500 genes for SNV and indel detection and 55 genes for fusion and splice variants detection
  • Matches patients to available FDA-approved targeted therapy and immunotherapy, or clinical trials to tailor cancer treatments
  • Provides comprehensive genomic analysis and biomarker status from limited tissue in one test
  • Covers all NCCN guideline-recommended genes in solid tumors, emerging biomarkers, and genes involved in over 1600 clinical trials

Recommended For:

  • Newly diagnosed patients
  • Recurrent and metastatic disease
  • Patients who are not responding well to current standard-of-care treatments

TissueHRD


A companion diagnostic test that detects mutations in HRD genes

Cancer Type
···
Sample Type
···
Turnaround Time
···
Ovarian, Breast, Prostate and Pancreas FFPE Tumor Tissue 4 Weeks

TissueHRD™ is a companion diagnostic test that detects pathogenic mutations in genes implicated in the homologous recombination pathway to determine the homologous recombination –deficiency (HRD) status of a tumor. HRD has been associated with improved outcomes using DNA-damaging therapies. Knowing the HRD status of a tumor can guide treatment selection of FDA-approved PARP inhibitors and other DNA-damaging agents.


Target List
Genes
ARID1A  BARD1 CHEK1  FANCD2  FANCL  RAD50 
ATM BLM CHEK2  FANCE  MRE11A  RAD51 
ATRX BRCA1 FANCA  FANCF  NBN  RAD51B 
BAP1 BRCA2 FANCC  FANCG  PALB2   

Recommended For:

  • Comprehensive analysis of genes associated with HRD, including BRCA1 and BRCA2
  • Identifies patients who may benefit from PARPi treatment

Recommended For:

  • Patients with ovarian, breast, prostate, and pancreatic cancers

Tissue PD-L1 Triplex


Match patient's suitability across 3 immunotherapy drugs in 1 test.

Cancer Type
···
Sample Type
···
Turnaround Time
···
All Cancer Types FFPE Tumor Tissue 3 Weeks

The world’s first immunohistochemistry (IHC) tissue test that concurrently determines the expression of 3 clinically relevant tumor programmed death-ligand 1 (PD-L1) clones in 1 tissue sample.

Using quantitative multiplex fluorescence-IHC, Tissue PD-L1 Triplex™ determines the expression of PD-L1 clones SP142, SP263 and 22C3 in tumor cells and tumor-infiltrating immune cells which in turn, provides insights to the potential response of the patient towards immunotherapy.

IMMUNOTHERAPY MATCH
Atezolizumab Durvalumab Pembrolizumab Nivolumab
Non-Small Cell Lung Cancer (NSCLC) SP142 ≥ 50% TPS or ≥ 10% IC associated with enhanced overall survival SP263 ≥ 1% TPS – Post chemoradiation therapy (CRT) SP263 ≥50% TPS – First Line

SP263 ≥1% TPS – Second Line

 

22C3 ≥50% TPS – First Line

22C3 ≥1% TPS – Second Line

SP263 ≥1%, ≥5% and ≥10% TPS – Second Line
Urothelial Carcinoma SP142 ≥ 5% IC SP263 ≥25% TPS – Second Line

SP263 ≥ 25% IC – Second Line

Triple Negative Breast Cancer (TNBC) SP142 ≥ 1% IC


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