31 January 2020 - - US-based diagnostics company Biodesix, Inc. and Streck, Inc. has inked a Regulatory Cooperation Agreement that will further enable both companies in their pursuit of FDA approval for diagnostic testing services and specimen collection products, the companies said.

Biodesix, a lung cancer diagnostic solutions company, previously announced plans to seek FDA approval for future genomic tests on Next Generation Sequencing and Droplet DigitalTM PCR (ddPCRTM) platforms as companion diagnostics.

This collaboration will allow integration of Streck's proprietary blood collection tubes and preservatives into Biodesix's sample collection protocols.

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 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.

Established in 1971, Streck develops and manufactures products in hematology, immunology, molecular diagnostics, cell stabilisation, infectious diseases and urinalysis for clinical and research laboratories.

Streck's passion for innovation, quality and service are what makes the organiasation a world leader in the development of quality control and diagnostic products helping laboratories ensure accurate and timely results for patients.