Collaboration to Further Shared Goals in Obtaining FDA Approvals for Biodesix Diagnostic Testing and Streck Blood Collection Tubes
BOULDER, CO and LA VISTA, NE, January 29, 2020 – 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 Digital™ PCR (ddPCR™) 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.”
Biodesix is a lung cancer diagnostic solutions company covering the continuum of patient care from early risk classification of lung nodules through treatment guidance in late stage cancer. The company develops diagnostic tests addressing important clinical questions by combining simple blood draws and multi-omics through the power of artificial intelligence. Biodesix is the first company to offer four best-in class non-invasive tests for patients with lung cancer or suspicious lung nodules. The Biodesix Lung Reflex® strategy for lung cancer patients integrates the GeneStrat® and VeriStrat® tests to support treatment decisions with results in 72 hours, expediting time to treatment. The Nodify XL2™ test and the Nodify CDT TM test evaluate the risk of malignancy in incidental pulmonary nodules, enabling physicians to triage patients to the most appropriate course of action. The company’s strong product pipeline addresses key clinical questions in all stages of lung cancer, from risk assessment of early stage disease to informing treatment decisions for emerging therapies. Biodesix also partners with the world’s leading biotechnology and pharmaceutical companies to solve complex diagnostic challenges. For more information about Biodesix, please visit www.biodesix.com
About Streck, Inc.
Established in 1971, Streck develops and manufactures products in hematology, immunology, molecular diagnostics, cell stabilization, infectious diseases and urinalysis for clinical and research laboratories. Streck’s passion for innovation, quality and service are what makes the organization a world leader in the development of quality control and diagnostic products helping laboratories ensure accurate and timely results for patients.
Jordona Jackson Smith for Biodesix
Dan Dwyer for Streck