Biodesix expands partnership with Bio-Rad to develop IVD assays for sensitive genomic detection in oncology, including breast cancer.
Quiver AI Summary
Biodesix, Inc. announced an expanded partnership with Bio-Rad to develop, clinically validate, and submit regulatory applications for in vitro diagnostic assays aimed at detecting multiple genomic markers in oncology. Utilizing Bio-Rad's Droplet Digital™ PCR technology, the collaboration will first focus on validating the ddPLEX ESR1 Mutation Detection Assay, crucial for advanced breast cancer treatment. Once validated, Biodesix will manufacture specimen collection kits and offer the assay through its accredited laboratory, also seeking reimbursement from CMS. This partnership highlights the importance of rapid and sensitive assays in addressing clinical needs in oncology, with both companies set to present their initiatives at the upcoming AMP conference.
Potential Positives
- Biodesix is expanding its partnership with Bio-Rad, showcasing its commitment to enhancing its diagnostic capabilities in oncology through the development of sensitive assays.
- The agreement will lead to the introduction of the ddPLEX ESR1 Mutation Detection Assay, addressing an urgent clinical need for advanced breast cancer treatments.
- This initiative signals Biodesix's focus on personalized medicine, which is increasingly demanded in the oncology market, potentially leading to improved clinical outcomes.
- Once validated, the new assay will be marketed to both biopharma and clinical customers, expanding Biodesix's service offerings and market reach in cancer treatment support.
Potential Negatives
- The requirement for regulatory clearance before the assays can be offered could delay the introduction of the new diagnostic tests to the market.
- Seeking reimbursement through the CMS may indicate potential financial challenges, as reimbursement processes can be complex and time-consuming.
- While Biodesix is expanding its product offerings, reliance on partnerships with other companies like Bio-Rad could raise concerns about the company's control over its products and technology.
FAQ
What is the new partnership agreement about?
Biodesix has signed an expanded partnership with Bio-Rad to develop and validate IVD assays for oncology using ddPCR technology.
What is the significance of the ESR1 Mutation Detection Assay?
The ESR1 assay is crucial for detecting mutations in HR+/HER2- advanced breast cancer, supporting personalized treatment options.
How will Biodesix support the validation of the assays?
Biodesix will conduct clinical validation, regulatory submissions, and will manufacture specimen collection kits for the developed assays.
When will Biodesix provide more information on this agreement?
More details on the partnership and R&D plans will be shared at the AMP conference, Nov 11-15, in Boston, MA.
How will the new assays benefit cancer patients?
The assays will enable rapid and sensitive detection of biomarkers, improving personalized treatment and monitoring for advanced breast cancer patients.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
$BDSX Insider Trading Activity
$BDSX insiders have traded $BDSX stock on the open market 21 times in the past 6 months. Of those trades, 6 have been purchases and 15 have been sales.
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- JACK W SCHULER has made 6 purchases buying 8,372,029 shares for an estimated $3,928,046 and 0 sales.
- SCOTT HUTTON (President & CEO) has made 0 purchases and 3 sales selling 7,547 shares for an estimated $2,914.
- ROBIN HARPER COWIE (CFO, Sec'y & Treasurer) has made 0 purchases and 3 sales selling 1,980 shares for an estimated $764.
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Wall Street analysts have issued reports on $BDSX in the last several months. We have seen 4 firms issue buy ratings on the stock, and 0 firms issue sell ratings.
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$BDSX Price Targets
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Full Release
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
[email protected]
(720) 925-9285
Investors:
Chris Brinzey, Partner, ICR
[email protected]
(339) 970-2843
