NEW YORK – Lucence said Wednesday that its LiquidHallmark liquid biopsy test is now covered under a local coverage decision from Medicare administrative contractor Palmetto GBA, through its MolDx technology assessment group.
The LCD (L38043) covers all guideline-recommended molecular biomarkers in advanced lung cancer patients and enables Lucence to bill Medicare and Medicare Advantage plans using a specific Medicare DEX code (Z00V8) for the LiquidHallmark circulating tumor DNA (ctDNA) assay administered to most Medicare fee-for-service lung cancer patients meeting clinical criteria.
The LCD was originally issued for Guardant Health's Guardant360 liquid biopsy and covers other liquid biopsies for the same indications if they display similar performance to Guardant360 in their intended applications.
Lucence's next-generation sequencing-based test is intended to help oncologists identify biomarkers in advanced cancer patients that may inform their treatment decisions. The company is currently working to show non-inferiority of LiquidHallmark versus Guardant360 via a head-to-head comparison trial called LIQUIK.
Interim results were presented last year at the International Society of Liquid Biopsy congress in Miami. Those results, taken from the first 60 LIQUIK participants, demonstrated that LiquidHallmark detected at least one of nine actionable genes (G9) in 24 of 33 patients with tissue-confirmed G9 biomarkers. By comparison, data showed that Guardant360 detected at least one such biomarker in 21 of 33 patients.
The interim results also showed that LiquidHallmark demonstrated between 94.5 and 100 percent concordance with tissue-based profiling, depending on the given G9 biomarker.
Although LiquidHallmark had identified more biomarkers than Guardant360 in that analysis, the study is ongoing and the statistical significance of the results at that time point was not evaluated.
While Lucence CEO Min-Han Tan did not say how many participants are currently enrolled in the study, he commented that the firm plans to present more data from the LIQUIK study at June's annual conference of the American Society of Clinical Oncology.
The company also plans to present updates on its ctRNA expansion of LiquidHallmark at that conference.
LiquidHallmark is currently marketed as a lab-developed test, and for now, the company intends to keep it that way. Tan commented, however, that "we are evaluating pursuing FDA approval for LiquidHallmark."
The company is also pursuing coverage decisions for LiquidHallmark in other indications.
"Multi-cancer coverage with LiquidHallmark is a key next priority," Tan said.