Biodesix and Streck sign agreement to secure FDA approval for products

30 January 2020 (Last Updated January 30th, 2020 11:34)

Lung cancer diagnostic solutions company Biodesix and Streck have signed a regulatory cooperation agreement to secure FDA approval for diagnostic testing services and specimen collection products.

Lung cancer diagnostic solutions company Biodesix and Streck have signed a regulatory cooperation agreement to secure FDA approval for diagnostic testing services and specimen collection products.

Under the agreement, the companies will share goals to obtain approvals for Biodesix Diagnostic Testing and Streck Blood Collection Tubes.

Earlier, Biodesix announced plans to seek approval from the FDA for future genomic tests on Next Generation Sequencing (NGS) and Droplet Digital PCR (ddPCR) platforms as companion diagnostics.

With the latest partnership, Streck’s proprietary blood collection tubes (BCTs) and preservatives can be integrated into Biodesix’s sample collection protocols.

Biodesix CEO Scott Hutton said: “The rapid turnaround of blood-based tumour profiling allows patient access to targeted therapies as first-line treatments, which is the cornerstone of precision medicine.

“However, there is limited access to these technologies with only one companion diagnostic test and no broad sequencing tests using blood instead of tissue samples having been approved by the FDA to date.

“The result is a reduced need for specimen processing at the point of collection and easy transport to our lab for testing.”

Biodesix plans to bring multiple blood-based tests through the FDA for approval to address the unmet need for practising oncologists and their patients.

Streck CEO Connie Ryan said that these partnerships allow patients to receive crucial results that can impact their quality of life while improving health outcomes for those most vulnerable.

In July 2018, Biodesix acquired Integrated Diagnostics (Indi) and its complementary oncology product, the XL2 test aimed at improving the diagnosis of lung cancer.