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.

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Our clinical research has resulted in over 90 peer-reviewed publications for our tests. In addition to clinical studies, we are collaborating with investigators from multiple academic cancer centers. On June 3, 2022, we announced the intent to develop a new novel molecular minimal residual disease (MRD) test as a part of a master sponsored research agreement (MSRA) with Memorial Sloan Kettering Cancer Center (MSK). In addition, the MSRA between MSK and the Company also includes the potential future development of other diagnostic tests aimed at improving the treatment of cancer. On March 25, 2024, we announced a new master collaborative research agreement (MCRA) with MSK under which the teams will collaborate on a development plan for diagnostic tests aimed at improving the treatment of cancer. Biodesix will utilize its array of genomics, proteomics, and data mining capabilities with the aim of developing and commercializing oncology biomarker assays in collaboration with MSK. Bio-Rad will provide its industry-leading digital PCR assay technology in support of this important work. We believe these studies and collaborative arrangements are critical to gaining physician adoption and driving favorable coverage decisions by payers and expect our investments in research and development to increase. Further, we also expect to increase our research and development expenses to fund further innovation and develop new clinically relevant tests.