Tempus clocks FDA approval for 648-gene cancer test

The time has come for Tempus to secure its first premarket approval from the FDA, with a green light for a companion diagnostic to help profile the underlying genetic makeup of solid tumors.

Dubbed xT CDx, the 648-gene test was given the go-ahead to be paired up with two targeted therapies for colorectal cancer—Amgen’s Vectibix (panitumumab), and Bristol Myers Squibb and Eli Lilly’s Erbitux (cetuximab)—to check for certain KRAS biomarkers and help identify the patients most likely to benefit from the treatments.

In addition, the prescription diagnostic can be used to determine a patient’s microsatellite-instability status, or a sign that the body’s ability to fix small errors in DNA is not functioning correctly. By parsing DNA from tumor samples, it can also identify a range of certain mutations that can help manage patients.

Tempus said in its announcement that it now plans to broaden xT CDx’s reach and pursue more companion diagnostic claims through partnerships with additional cancer drugmakers. 

The artificial intelligence and genomic diagnostic developer previously worked with Eli Lilly to help provide DNA sequencing tests to patients with non-small cell lung cancer at no cost. According to Tempus, nearly half of patients with advanced forms of the disease also have a genetic biomarker that could help guide treatment.