First FDA Approved CDx for RET fusion-positive metastatic non-small cell lung cancer (NSCLC)

The FDA has granted premarket approval to Thermo Fisher Scientific’s Oncomine Dx Target Test as a companion diagnostic (CDx) to identify RET fusion-positive metastatic non-small cell lung cancer (NSCLC) patients who are candidates for GAVRETO^™ (pralsetinib), a recently approved targeted therapy developed by Blueprint Medicines. This makes the Oncomine Dx Target Test the first NGS-based companion diagnostic for RET fusion-positive NSCLC and expands the test’s utility.

GAVRETO is a potent and selective once-daily oral therapy designed to target RET fusions and mutations. RET fusions are believed to be key disease drivers in about 1-2 percent of patients with NSCLC, which accounts for 85 percent of all lung cancers in the United States. New data show that NSCLC mortality has been declining in recent years, suggesting that advances in treatment, including targeted therapies, may be contributing to improved survival rates.

The Oncomine Dx Target Test simultaneously evaluates 23 genes clinically associated with NSCLC. In 2017, the FDA approved it as a CDx to identify patients who may be eligible for specific targeted therapies. The Oncomine Dx Target Test is currently approved and reimbursed by government and commercial insurers in the U.S., Europe, Japan, South Korea and Israel, covering more than 550 million lives globally.

Want more of the latest science news straight to your inbox? Become a SelectScience member for free today>>