Amgen

The companies are aiming to develop Idylla-based CDx biomarker tests for a compound Amgen is developing to treat solid tumors.

The companies are seeking to register Biocartis' Idylla RAS biomarker tests with the FDA as companion diagnostics for Amgen's Vectibix.

Illumina and Amgen co-developed the test, which will determine whether metastatic colorectal cancer patients will benefit from Vectibix.

At issue is the lack of reference samples for evaluating the performance of LDTs that may determine which patients are appropriate for specific cancer drugs.  

The companies plan to codevelop Adaptive's ClonoSeq assay to measure minimal residual disease in ALL. 

A week after being hit with a GAO report that called test results from consumer genetics firms "misleading," the big three DTC companies criticized the agency for using "unscientific" methods in its undercover investigation, but welcomed greater regulatory oversight.