FDA OKs Liquid Biopsy to Determine EGFR-Trip Lung Cancer

WASHINGTON — The FDA on Friday accredited the Guardant360 CDx assay to establish metastatic lung most cancers patients who lift explicit EGFR mutations, making them eligible for upfront medication with osimertinib (Tagrisso).

The less invasive take a look at — which contains subsequent-expertise sequencing (NGS) and cell-free tumor DNA — may perhaps presumably perchance lend a hand preserve away from tissue biopsies in patients who take a look at certain for these mutations, are less complicated to carry out in repeat vogue (to establish mechanisms of resistance), and can fair be worn when customary biopsies are now now not feasible (due to the tumor location, to illustrate).

If the explicit EGFR mutations are now now not detected, then a customary tissue biopsy ought to be performed, the company accepted.

“Approval of a companion diagnostic that uses a liquid biopsy and leverages subsequent-expertise sequencing marks a new period for mutation checking out,” Tim Stenzel, MD, PhD, director of the Plot of enterprise of In Vitro Diagnostics and Radiological Properly being on the FDA’s Heart for Gadgets and Radiological Properly being, talked about in a press launch. “As well to profiting from less invasive checking out, patients are equipped with a simultaneous mapping of multiple biomarkers of genomic alterations, in desire to 1 biomarker at a time, which is ready to translate to diminished wait times for beginning medication and provide insight into that you just are going to be ready to deem resistance mechanisms.”

With a single take a look at, NGS uses enormous-panel genetic sequencing and may perhaps presumably perchance detect mutations in up to 55 varied genes valid now, as in opposition to a single take a look at for every gene.

Of their approval perceive, FDA specifically accepted that while “Guardant360CDx can provide data on multiple stable tumor biomarkers, currently’s approval is explicit to its use in identifying EGFR mutations in patients who may perhaps presumably perchance lend a hand from medication with Tagrisso.”

While FDA didn’t cite any explicit trial in reinforce of the approval, accuracy of the blood-basically based entirely take a look at used to be compared with tissue biopsy in the NILE glimpse, which included 282 non-small cell lung most cancers (NSCLC) patients and examined for a broader range of mutations for which first-line therapies are on hand (EGFR, ALK, ROS1, BRAF, RET, MET, and ERBB2). The 2 biopsy methods showed high concordance for basically the most crucial-line diagnosis of NSCLC, with tissue biopsy identifying guiding principle-urged therapies for 21.3% of patients, while Guardant360 CDx identified on hand therapies in 27.3% of the cohort.

Last Updated August 07, 2020