Biodesix Announces Expanded Bio-Rad Laboratories Partnership Agreement to Develop Droplet Digital™ PCR High Complexity Assays

Rhea-AI Summary

Biodesix (NYSE:BDSX) announced on Oct 22, 2025 an expanded partnership with Bio-Rad to develop, clinically validate, and pursue regulatory clearance for Droplet Digital PCR (ddPCR) in vitro diagnostic assays on Bio-Rad's QX600 platform.

Key first-step work includes validation of Bio-Rad's ddPLEX ESR1 Mutation Detection Assay for HR+/HER2- advanced breast cancer, manufacturing and distribution of specimen collection kits after clearance, offering the assay as a test at Biodesix's CLIA-CAP laboratory, and seeking CMS reimbursement. Both companies will present further details at AMP, Nov 11-15, 2025 in Boston.

Positive

• Expanded partnership with Bio-Rad to develop ddPCR IVD assays
• Biodesix to perform development, clinical validation, regulatory submissions
• Plan to manufacture and distribute specimen collection kits post-clearance
• ddPLEX ESR1 assay will be offered at Biodesix CLIA-CAP laboratory
• Company will seek CMS reimbursement for the ESR1 assay

Negative

• Commercial availability is contingent on regulatory clearance
• Reimbursement outcomes depend on CMS review and are not guaranteed

Insights

Clinical Molecular Diagnostics Strategist

Expanded Bio‑Rad partnership and ddPLEX ESR1 validation positions Biodesix to add a sensitive clinical ctDNA assay and commercial kit capability.

Biodesix will develop, clinically validate, and seek regulatory clearance for the ddPLEX ESR1 Mutation Detection Assay on Bio‑Rad's QX600 ddPCR platform and plans to manufacture specimen kits and offer the assay from its CLIA‑CAP lab. This creates a clear commercial pathway from assay development to clinical service and kit distribution, and the explicit plan to seek CMS reimbursement increases the revenue‑model relevance beyond research use.

The outcome depends on three concrete dependencies: regulatory clearance of the IVD assay, successful clinical validation demonstrating sensitive, specific ESR1 detection in ctDNA, and CMS reimbursement. Key near‑term items to watch are completion of clinical validation and regulatory submission timing, plus any CMS coverage decision; both are likely to unfold within the regulatory and reimbursement timelines following validation, including details to be discussed at the AMP meeting on Nov 11-15, 2025 and workshops on Nov 12, 2025. These milestones will determine commercial uptake by biopharma and clinicians and the timing of kit revenue.

Biodesix will perform the clinical validation of ddPLEX ESR1 Mutation Detection Assay for advanced breast cancer testing 

LOUISVILLE, Colo., Oct. 22, 2025 (GLOBE NEWSWIRE) -- Biodesix, Inc. (NYSE: BDSX), a leading diagnostics solutions company, today announced the signing of an expanded partnership agreement under which Biodesix will conduct the development, clinical validation, and regulatory submissions of in vitro diagnostic (IVD) assays to enable highly sensitive detection of multiple genomic markers focused on oncology applications, utilizing Bio-Rad’s Droplet Digital™ PCR (ddPCR™) technology on Bio-Rad’s QX600 platform. Following regulatory clearance, Biodesix will manufacture and distribute dedicated specimen collection kits for the developed assays.

The first assays to be validated under the agreement include Bio-Rad’s ddPLEX ESR1 Mutation Detection Assay. ESR1 testing is becoming critical in HR+/HER2- advanced breast cancer due to the clinically demonstrated survival benefits from a new generation of therapy called oral selective estrogen receptor degraders (SERDs). The ddPLEX ESR1 Mutation assay will enable highly sensitive detection and absolute quantification of multiple ESR1 mutations from ctDNA samples.

Once validated, the ESR1 assay will be offered as a test service at Biodesix’ accredited CLIA-CAP laboratory for biopharma customers to support the development of targeted therapeutics, as well as for clinical customers to support cancer treatment monitoring. Biodesix will also seek reimbursement for this assay through Centers for Medicare & Medicaid Services (CMS).

“The emergence of ESR1 mutations as biomarkers for breast cancer has had a significant impact on the oncology market, leading to an increased global demand for rapid, sensitive assays,” said Scott Hutton, CEO, Biodesix. “We are proud to expand our partnership with Bio-Rad through this new agreement, demonstrating how our combined capabilities in mutation detection can address clinical needs with speed and precision, and opening doors to personalized, data-driven medicine.”

“Through our long-standing relationship with Biodesix we have effectively delivered both clinical and research-based applications of our ddPCR technology for non-small cell lung cancer, as part of its Lung Diagnostics portfolio,” commented Steve Kulisch, VP Product Management, Life Science Group, Bio-Rad Laboratories. “Validation of our ddPLEX ESR1 kits will further expand our combined capabilities in clinical diagnostics, increasing access to sensitive biomarker detection for advanced breast cancer.”

At the upcoming AMP conference, Nov 11-15, Boston, MA, both companies will be providing more detail on their R&D visions, partnerships, and commercial roadmaps:

• Bio-Rad Laboratories Corporate Workshop, Nov 12, at 8:00 am ET
• Biodesix Corporate Workshop, Nov 12, at 4:00 pm ET

About Biodesix:

Biodesix is a leading diagnostic solutions company, driven to improve clinical care and outcomes for patients. Biodesix Diagnostic Tests, marketed as Nodify Lung® Nodule Risk Assessment and IQLung® Cancer Treatment Guidance, support clinical decisions to expedite personalized care and improve outcomes for patients with lung disease. Biodesix Development Services enable the world’s leading biopharmaceutical, life sciences, and research institutions with scientific, technological, and operational capabilities that fuel the development of diagnostic tests, tools, and therapeutics. For more information, visit biodesix.com.

Biodesix Contacts:
Media:
Natalie St. Denis, Director Corporate Communications, Biodesix
natalie.stdenis@biodesix.com
(720) 925-9285

Investors:
Chris Brinzey, Partner, ICR
chris.brinzey@icrhealthcare.com
(339) 970-2843

FAQ

What did Biodesix (BDSX) announce on Oct 22, 2025 about Bio-Rad?

Biodesix announced an expanded partnership to develop and clinically validate ddPCR IVD assays on Bio-Rad's QX600 platform.

Which assay is first under the Biodesix and Bio-Rad agreement for BDSX?

The first assay is Bio-Rad's ddPLEX ESR1 Mutation Detection Assay for advanced breast cancer.

Will Biodesix offer the ddPLEX ESR1 test to clinicians and biopharma for BDSX?

Yes; once validated, Biodesix will offer the ESR1 assay as a service at its CLIA-CAP laboratory for biopharma and clinical customers.

Will Biodesix (BDSX) manufacture kits for the ddPLEX ESR1 assay?

Yes; following regulatory clearance, Biodesix will manufacture and distribute dedicated specimen collection kits.

Is commercial launch of the BDSX ESR1 assay immediate after the announcement?

No; commercial availability is subject to regulatory clearance and validation steps.

Will Biodesix (BDSX) seek reimbursement for the ddPLEX ESR1 assay from CMS?

Yes; Biodesix will seek Centers for Medicare & Medicaid Services reimbursement for the assay.