Amgen has signed up to help Biocartis get its RAS biomarker tests approved in the U.S. The pact positions Biocartis to register its Idylla RAS tests as companion diagnostics for Amgen's colorectal cancer drug Vectibix.
The FDA updated the Vectibix label in June to include use in metastatic colorectal cancer patients with wild-type RAS. Illumina picked up a simultaneous nod for an extended RAS panel that runs on its MiSeqDx system, enabling laboratories to help doctors identify patients eligible for treatment with Vectibix. The simultaneous approval was the result of three years of collaboration between Amgen and Illumina.
Now, Amgen has struck a deal to bring another Vectibix companion diagnostic to market. The big biotech will provide “financial and operational” support to help Biocartis bring its Idylla KRAS and NRAS-BRAF mutation tests through the premarket approval process.
Biocartis thinks Idylla can increase uptake of RAS testing and cut turnaround times. The automated platform uses PCR to analyze samples.
Notably, Biocartis thinks facilities of any size and experience can use the system with minimal training and quickly generate results. The turnaround time clocks in at 150 minutes, according to Biocartis, and the hands-on time is no more than two minutes.
The hands-on time for Illumina’s extended RAS panel is more than three hours.
Amgen noted the speed of Biocartis’ process in its comments on the deal.
“We are excited to collaborate with Biocartis to apply novel technologies as we seek to deliver expedited RAS biomarker test results that will help to identify patients that may benefit the most from Vectibix,” Amgen VP Greg Friberg said in a statement.
Amgen has firsthand experience with Idylla. The companies began working together on the RAS tests early last year, at which time the scope of the deal was limited to seven countries, most of which were emerging markets. Amgen expanded the deal to cover up to 10 European countries this time last year and is now set to help bring the tests to its home market.