StemCell Therapy

A diagnostics subsidiary of Swiss drugmaker Roche has filed for approval of its liquid biopsy test and anticipates a Food and Drug Administration ruling in the first half of this year.

In an interview at the J.P. Morgan Healthcare Conference in San Francisco, Foundation Medicine CEO Cindy Perettie said the company filed for FDA approval of the FoundationOne Liquid test at the end of December. The approval would include companion diagnostics claims, as well as claims for microsatellite instability and blood tumor mutation burden. The company anticipates that the test would be covered under the National Coverage Determination for next-generation sequencing, rather than there being a need to obtain a new NCD. The company applied for approval in parallel with its biopharma partners, though Perettie declined to name them.

In October, the company presented data from the Phase II/III BFAST study which is enrolling 580 patients with non-small cell lung cancer on people receiving Roches drug Alecensa (alectinib), a drug that targets ALK fusions, a genetic driver of NSCLC. Among 2,219 screened and 2,188 whose tests yielded blood-based next-generation sequencing results, 5.8% were found to have ALK fusions. The overall response rate for patients in the study who received Alecensa was 87.4%, which investigators wrote resulted in a high response rate and clinical benefit among patients receiving the drug and validated liquid biopsys clinical utility in ALK fusion-positive NSCLC.

Having that concordance gives us a lot of confidence, Perettie said, referring to the ability of liquid biopsy to detect mutations at a rate comparable to what has been found before.

Although BFAST was not specifically designed to show head-to-head concordance with tissue biopsy, research has indicated that ALK fusions are present in 4-6% of NSCLC cases.

The study is also enrolling patients who receive Rozlytrek (entrectinib), an inhibitor of NTRK fusions, which are also genetic drivers of cancers, among other drugs.

Concordance is a crucial consideration with liquid biopsy because, while significantly less cumbersome than tissue biopsy, it of course would defeat the purpose of using liquid biopsy if patients who have undergone it nevertheless must still undergo tissue biopsy as well.

Photo: ImagesBazaar, Getty Images

Link:
Foundation Medicine touts concordance ahead of FDA ruling on liquid biopsy test - MedCity News

This entry was posted on January 21, 2020 at 8:45 am and is filed under Genetic medicine. You can follow any responses to this entry through the RSS 2.0 feed. Both comments and pings are currently closed. |