Biocartis submits 510(k) to FDA, expands European hospitals deal with Amgen

Biocartis submits 510(k) to FDA, expands European hospitals deal with Amgen

December 22, 2016 Off By Dino Mustafić

Biocartis has today strenghten its collaboration with two companies;  J&J’s Jansen and Amgen, as it has submitted 510(k) its diagnostics platform Idylla to the U.S. Food and Drug Administration (FDA), and it has set up to enable hospitals in Europe to get RAS biomaker information, using Idylla and RAS tests.

A 510(k) is a premarket submission (PMA) made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to PMA.

Biocartis said on Thursday that the submission of 510(k) was done in parallel with the 510(k) submission by Biocartis’ strategic partner Janssen Diagnostics (a Janssen Pharmaceutical Company of Johnson & Johnson) of the Janssen Idylla(TM) Respiratory (IFV-RSV) Panel Test.

In another press release the same day, Biocartis said it had signed a new collaboration agreement with biotechnology company Amgen. The new agreement builds on the existing collaboration is set up to accelerate access to RAS biomarker information in up to 10 European countries.

Based on the experience so far,  Biocartis and Amgen will now aim to enable several dozen additional selected hospitals in Europe to accelerate access to RAS biomarker information, from up to one month to same-day results for mCRC patients, using Biocartis’ Idylla platform and RAS tests.

Ulrik Cordes, EVP Pharma Collaborations and Companion Diagnostics, commented: “This 510(k) submission was a joint effort between the teams of Janssen Diagnostics and Biocartis, and another great achievement resulting from the longstanding strategic partnership between both companies. The experience of the Janssen Diagnostics’ team has been of much added value in preparing for this submission and we want to thank our partner for their continued commitment and support.”

Commenting expanding agreement with Amgen, Rudi Pauwels, Chief Executive Officer of Biocartis, said:  “We are very pleased to have expanded our agreement with Amgen. This strong partnership will help to further boost the footprint of Idylla systems in Europe. Additionally, it is another step towards our ultimate goal of improving patient access to rapid and reliable biomarker information with the potential to enable more rapid treatment selection.”