The study, published in PLOS ONE, establishes LiquidHALLMARK’s market-leading sensitivity and identifies actionable biomarkers in majority of cancer patients and 70% of lung cancer patients; Mary Jo Mullen joins the Company as SVP, Commercial to oversee US market growth
Palo Alto, CA, May 19th, 2022—Lucence, the precision oncology company pioneering ultrasensitive liquid biopsy tests, is announcing the recent publication of a study validating its LiquidHALLMARK ctDNA liquid biopsy assay in PLOS ONE, a peer-reviewed, open access scientific journal. The study results establish high sensitivity, specificity, accuracy and precision of LiquidHALLMARK, based on the AmpliMark amplicon-sequencing platform, and support compelling clinical applications for its use.
“In the lab and in the real-world, LiquidHALLMARK’s performance is market-leading. We are truly excited about what this means for patients—and the potential to expand access to non-invasive testing that can drive earlier detection, treatment selection, and monitoring for everyone,” said Min-Han Tan, Founding CEO and Medical Director at Lucence.
Analytical validation using reference genetic materials demonstrated a sensitivity of 99.38% for point mutations and 95.83% for insertions/deletions at 0.1% variant allele frequency (VAF), and a sensitivity of 91.67% for gene fusions at 0.5% VAF. Orthogonal comparison of EGFR variant calls made by LiquidHALLMARK and a reference allele-specific PCR method for 355 lung cancer specimens revealed an overall concordance of 93.80%. External validation with cobas® EGFR Mutation Test v2 for 50 lung cancer specimens demonstrated an overall concordance of 84.00%, with a 100% concordance rate for EGFR variants above 0.4% VAF.
Clinical application of LiquidHALLMARK in 1,592 patients demonstrated both a high detection rate and broad actionability. Of these clinical samples, 74.8% harbored at least one clinically useful biomarker for drug targeting, clinical trial inclusion, or disease monitoring, including 36.2% with on-label drug recommendations. Among ctDNA-positive lung cancers, 83.1% (n = 511) harbored at least one genetic biomarker possessing biological evidence for actionability and 72.5% harbored at least one biomarker with a guideline-approved drug indication.
Lucence continues to build scientific and commercial momentum, and this recent publication follows several notable company milestones, including the announcement of its combined ctDNA + ctRNA assay.
The Company is also pleased to announce that biopharma and diagnostics veteran Mary Jo Mullen has joined Lucence as Senior Vice President of Commercial. Mary Jo oversees the Commercial, Sales, Client Services, and Marketing teams at Lucence and is responsible for reimbursement and payer strategy as well as partnerships.
Mary Jo was previously Chief Commercial Officer at bioTheranostics (acquired by Hologic) where she led Sales, Marketing, and Client Services for two cancer diagnostics. She was part of senior leadership at Genzyme Genetics (acquired by LabCorp) where she helped guide the Oncology and Reproductive Health businesses. Most recently, Mary Jo was VP of Market Access at AMAG Pharmaceuticals (acquired by COVIS), where she developed and managed the market access plan for two new FDA approved products and a legacy product label expansion leading to 80% reimbursement within the first 12 months of launch. Mary Jo is the recipient of Healthcare Businesswomen’s Association’s Luminary Award, given to senior women leaders who serve as a role model in their company, actively mentor and sponsor others, help advance other women’s careers, and exhibit dedication to the healthcare industry.
Lucence’s LiquidHALLMARK ctDNA liquid biopsy assay covers a wide range of clinically relevant cancer biomarkers, including mutations in 80 genes in 15 cancer types. LiquidHALLMARK ctDNA and ctRNA combines ctRNA profiling of 27 actionable and emerging fusions with ctDNA profiling for enhanced fusion detection. LiquidHALLMARK is powered by AmpliMark, the Company’s proprietary amplicon-based sequencing technology, which uses a unique molecular barcode and error-correction technology to maximize test sensitivity across multiple mutation types.. LiquidHALLMARK ctDNA testing is currently available to US oncologists as a laboratory developed test and used by physicians at NCI-designated centers across the country.