Biodesix, Inc., and Streck, Inc. today announced a Regulatory Cooperation Agreement that will further enable both companies in their pursuit of FDA approval for diagnostic testing services and specimen collection products.
Biodesix, a leading lung cancer diagnostic solutions company, previously announced plans to seek FDA approval for future genomic tests on Next Generation Sequencing (NGS) and Droplet DigitalTM PCR (ddPCRTM) platforms as companion diagnostics. This collaboration will allow integration of Streck’s proprietary blood collection tubes (BCTs) and preservatives into Biodesix’s sample collection protocols.
“The rapid turnaround of blood-based tumor 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. Biodesix is committed to addressing this unmet need for practicing oncologists and their patients by bringing multiple blood-based tests through the FDA for approval in the near future,” said Scott Hutton, Biodesix CEO. “This collaboration with Streck represents a significant step in that process, enabling Biodesix to incorporate Streck’s industry-leading BCTs into our protocols. The result is a reduced need for specimen processing at the point of collection and easy transport to our lab for testing.”
“Partnerships like this one between Streck and Biodesix allow patients to receive critical results that can impact their quality of life and improve health outcomes for those most vulnerable,” said Connie Ryan, CEO of Streck. “We are excited to work with Biodesix as we are both passionate about bringing this cutting-edge technology to the forefront of patient care.”
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Source: BioSpace
