Molecular diagnostics company Lucence today announced that the company’s Palo Alto laboratory received certification from the U.S. Department of Health and Human Services’ Centers for Medicare & Medicaid Services (CMS) under the Clinical Laboratory Improvement Amendments (CLIA) of 1988. With this accreditation, Lucence will rapidly scale United States-based testing capacity for its flagship liquid biopsy blood test, LiquidHALLMARK®, furthering the Company’s mission of advancing precision cancer care for the benefit of patients everywhere.
Dr. Tan Min-Han, Founding CEO of Lucence, said, “We are excited to expand our operations to offer the benefits of highly accurate amplicon-based liquid biopsy — quicker, more precise biomarker detection and less invasive testing — to even more patients. Our goal is to make non-invasive, ultrasensitive detection of clinically relevant biomarkers more accessible to oncologists across the country.”
This milestone marks accelerating momentum in the company’s US operations. Early next year, Lucence will launch its first major prospective, observational study. LIQUIK, Liquid Biopsy for Detection of Actionable Genomic Biomarkers in Patients with Advanced Non-small Cell Lung Cancer, will compare different liquid biopsy technologies with conventional tissue-based profiling in patients with newly diagnosed metastatic non-squamous non-small cell lung cancer to evaluate the clinical utility of LiquidHALLMARK.
LiquidHALLMARK covers a wide range of clinically relevant biomarkers, including mutations in 80 genes, fusions in 10 genes, and somatic variants in 15 cancer types. LiquidHALLMARK is powered by AmpliMARK™, the Company’s proprietary amplicon-based sequencing technology, which uses a unique molecular barcode and error-correction technology that improves test sensitivity across multiple mutation types for single nucleotide variants and fusion genes. AmpliMARK is the foundational technological innovation in Lucence’s liquid biopsy tests.
Earlier this year, the Company presented data at the American Society of Clinical Oncology Annual Meeting demonstrating high sensitivity of AmpliMARK at a limit of detection (LOD) of 0.1% variant allele frequency, detecting clinically relevant biomarkers in lung, breast and blood cancers. AmpliMARK demonstrated 97.4% concordance for recommended biomarkers in lung cancer when compared orthogonally with another liquid biopsy platform. CLIA-certification of the Company’s Palo Alto laboratory now ensures accelerated delivery of LiquidHALLMARK’s high resolution, target-rich insights to US clinicians and patients.