Biodesix Strengthens Alliance with Bio-Rad for PCR Assays
Biodesix Expands Partnership with Bio-Rad Laboratories
Biodesix, Inc. (NYSE: BDSX), a prominent name in diagnostics solutions, has just announced an exciting new chapter in its collaboration with Bio-Rad Laboratories. This expanded partnership aims to develop and clinical validate enhanced in vitro diagnostic (IVD) assays that focus on the detection of multiple genomic markers essential for oncology applications. Utilizing Bio-Rad’s advanced Droplet Digital PCR (ddPCR) technology on the QX600 platform, Biodesix is set to revolutionize the way multiple cancer biomarkers are detected.
Validation of New Assays for Oncology Applications
The first assay undergoing validation under this agreement is the ddPLEX ESR1 Mutation Detection Assay. ESR1 testing is pivotal in treating HR+/HER2- advanced breast cancer, as it has demonstrated considerable survival benefits thanks to emerging therapies known as oral selective estrogen receptor degraders (SERDs). This new assay will enable precise detection and quantification of various ESR1 mutations from circulating tumor DNA (ctDNA) samples, a critical advancement for both patients and healthcare providers.
Impact on Treatment and Patient Care
Post-validation, Biodesix plans to offer the ESR1 assay as a test service at its accredited CLIA-CAP laboratory, specifically tailored for biopharma clients whose work involves targeted therapeutics, as well as for clinical users who aim to monitor treatment for cancer patients. In addition, Biodesix intends to seek reimbursement options for the ESR1 assay through the Centers for Medicare & Medicaid Services (CMS), marking a significant step towards accessibility in cancer diagnostics.
Comments from Leadership
Scott Hutton, CEO of Biodesix, emphasized the importance of this development, stating, “The emergence of ESR1 mutations as biomarkers for breast cancer has significantly influenced the oncology market, leading to greater global demand for rapid, sensitive assays. We are thrilled to broaden our partnership with Bio-Rad through this new agreement, highlighting our ability to address clinical needs quickly and accurately, paving the way for personalized, data-driven medical approaches.”
Strengthening Clinical Diagnostics
In a similar vein, Steve Kulisch, VP of Product Management at Bio-Rad Laboratories, reflected on their longstanding relationship with Biodesix, indicating how they effectively utilize ddPCR technology for various applications, particularly related to non-small cell lung cancer. “The validation of our ddPLEX ESR1 kits will enhance our combined capabilities in clinical diagnostics and increase access to sensitive biomarker detection for advanced breast cancer treatment,” he remarked.
Upcoming Events and Information
Both Biodesix and Bio-Rad are eager to share more information regarding their research and development initiatives, as well as their commercial strategies during the upcoming AMP conference. Scheduled for November 11-15, the event will feature a variety of presentations, including a Corporate Workshop hosted by Bio-Rad on November 12 at 8:00 am ET, followed by a similar session by Biodesix later that day at 4:00 pm ET.
About Biodesix
Biodesix is dedicated to enhancing clinical care and outcomes through insightful diagnostics solutions. Their offerings include the Nodify Lung® Nodule Risk Assessment and IQLung® Cancer Treatment Guidance, which empower healthcare providers to make informed decisions in the treatment of lung disease. Additionally, Biodesix Development Services support leading biopharmaceutical and life sciences organizations with innovative technologies and operational excellence to facilitate the development of crucial diagnostic tests and therapies.
Contact Biodesix
Media Contacts:
Natalie St. Denis
Director of Corporate Communications
Biodesix
Email: natalie.stdenis@biodesix.com
Phone: (720) 925-9285
Investor Relations:
Chris Brinzey
Partner, ICR
Email: chris.brinzey@icrhealthcare.com
Phone: (339) 970-2843
Frequently Asked Questions
What is the focus of Biodesix's partnership with Bio-Rad?
The partnership focuses on developing highly sensitive droplet digital PCR assays aimed at cancer diagnostics, particularly for detecting genomic markers in oncology applications.
How will the new ESR1 assay benefit cancer patients?
The ESR1 assay will facilitate the precise detection and quantification of ESR1 mutations, aiding in the development of targeted therapeutics and monitoring treatment progress for patients.
Where will the ESR1 assay be offered?
Once validated, the ESR1 assay will be available as a test service at Biodesix’s accredited laboratory, catering to both biopharma and clinical customers.
What are the future plans for this partnership?
Both companies aim to enhance their research initiatives and expand access to sensitive biomarker detection, promoting advancements in cancer diagnostics.
How can I contact Biodesix for more information?
You can reach Biodesix's media contact, Natalie St. Denis, at natalie.stdenis@biodesix.com, or their investor contact, Chris Brinzey, at chris.brinzey@icrhealthcare.com.
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