FDA expands indication of FoundationOne Liquid CDx for use with Tabrecta
Click Here to Manage Email Alerts
The FDA approved FoundationOne Liquid CDx to be used as a companion diagnostic to identify MET exon 14 skipping in patients with metastatic non-small cell lung cancer, according to a company-issued press release.
The companion diagnostic, manufactured by Foundation Medicine, is intended to identify patients who may be eligible for treatment with capmatinib (Tabrecta, Novartis), a MET inhibitor.
“For [patients with lung cancer] with MET exon 14 skipping, having the option of a noninvasive liquid biopsy expands access to this first-of-its kind therapy and helps meet a critical patient need,” Brian Alexander, MD, MPH, CEO at Foundation Medicine, said in the release. “This approval, coupled with last year’s simultaneous therapy and companion diagnostic approval for Tabrecta and our tissue test, FoundationOne CDx, is an important advancement and demonstrates the value of having multiple highly validated comprehensive genomic testing options for physicians to consider for the individual needs of each patient.”
FoundationOne Liquid CDx — now approved as a companion diagnostic for nine targeted therapies for four cancer types — uses a blood sample to analyze over 300 cancer-related genes for genomic alterations. Additionally, the test provides information on microsatellite instability, blood tumor mutational burden and other single-gene alterations, like NTRK fusions, information that may help clinicians in choosing immunotherapy or other therapy types, according to the release.
Read more about
Click Here to Manage Email Alerts