Life Sciences Development Services

Biodesix offers partners the ability to develop, scale, and commercialize IVD and LDT tests, including specimen kitting and transport operations. We have a trusted reputation in the industry with an established framework of partnerships with major academic and physician networks focused on rapid test supplements, test discovery, establishing clinical utility, supported by expertise in regulatory and reimbursement pathways. We employ a multi-technology, collaborative approach to solving diagnostic challenges. We offer end-to-end diagnostic development services, including:

• translational research
• biomarker discovery
• assay design, development, and validation
• testing of prospective and retrospective clinical trial samples
• logistical support services, e.g., specimen collection and transport kits
• expertise in the regulatory, reimbursement, and commercial domains
• an off-the-shelf suite of research tests

Biodesix Development Services provide assay development and validation capabilities that utilize design-controlled laboratory processes, highly accredited quality management systems, and data generation in support of successful regulatory submissions. On behalf of its clients, Biodesix will conduct the development, clinical validation, and regulatory submissions of in vitro diagnostic (IVD) assays to enable highly sensitive detection of multiple genomic and proteomic markers focused on not only oncology applications. Following regulatory clearance, Biodesix will manufacture and distribute dedicated specimen collection kits for the developed assays.

Footnote: As presented at AMP 2025, Biodesix Corporate Workshop.