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Lucence Obtains CLIA Certification for Palo Alto Lab

NEW YORK – Lucence said on Thursday that its laboratory in Palo Alto, California has received CLIA certification from the Centers for Medicaid & Medicare Services.

Known as Lucence Health in the US, the Singapore-based firm plans to quickly scale US-based testing capacity for its LiquidHallmark liquid biopsy assay.

Based on Lucence's AmpliMark amplicon-based technology, the LiquidHallmark assay combines molecular barcoding and the firm's SunTzu.AI clinical analytics engine to detect multiple cancer-related mutations and viral targets.

"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," Tan Min-Han, CEO and founder of Lucence, said in a statement. "Our goal is to make non-invasive, ultrasensitive detection of clinically relevant biomarkers more accessible to oncologists across the country."

Lucence expects to launch its first major prospective, observational study, called Liquid Biopsy for Detection of Actionable Genomic Biomarkers in Patients with Advanced Non-small Cell Lung Cancer (NSCLC), early next year. The study will compare different liquid biopsy technologies with tissue-based profiling in patients with newly diagnosed metastatic NSCLC to evaluate the clinical utility of the firm's assay.

Lucence previously received CLIA certification for its Singapore lab in Sept. 2019.