eClinical Technology and Industy News

Lucence Announces Publication of Validation Study for LiquidHALLMARK ctDNA Liquid Biopsy Assay

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

Excerpt from the Press Release:

ALO ALTO, Calif.–(BUSINESS WIRE)–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.

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