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Biodesix partner, Friends of Cancer Research, publishes data in Clinical Cancer Research, demonstrating strong association between ctDNA changes and treatment outcomes for patients with solid tumor types

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Biodesix (NASDAQ: BDSX) and Bio-Rad Laboratories have contributed to groundbreaking research findings from Friends of Cancer Research's ctMoniTR Project, published in Clinical Cancer Research. The study demonstrates a strong correlation between circulating tumor DNA (ctDNA) changes and treatment outcomes in cancer patients.

The research expands on previous findings, analyzing multiple solid tumor types and treatment categories, including patients treated with tyrosine kinase inhibitors. The study utilized Bio-Rad's Droplet Digital™ PCR technology to detect ctDNA from patient samples.

Biodesix is currently exploring ctDNA in combination with proteomics to detect molecular residual disease (MRD), with latest advancements to be presented at the upcoming American Association for Cancer Research Annual Meeting on April 28th, 2025.

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Positive

  • Research validates ctDNA testing technology for cancer treatment monitoring
  • Expansion of study scope to multiple tumor types strengthens clinical evidence
  • Strategic partnership with Friends of Cancer Research enhances market position

Negative

  • None.

Insights

Biodesix's ctDNA research validation broadens cancer monitoring applications, strengthening their diagnostic portfolio without immediate revenue impact.

This peer-reviewed publication in Clinical Cancer Research validates Biodesix's ctDNA testing approach through the multi-stakeholder ctMoniTR Project. The research demonstrates a strong association between ctDNA changes and treatment outcomes across multiple solid tumor types, expanding beyond previous findings to advanced non-small cell lung cancer patients receiving immune checkpoint inhibitors. The new research now includes patients treated with tyrosine kinase inhibitors, widening potential applications.

The significance here is two-fold: first, it shows Biodesix's technology can effectively detect these clinically relevant biomarkers using Bio-Rad's Droplet Digital PCR platform; second, it supports potential integration of ctDNA analysis in both therapeutic development programs and clinical care pathways. This aligns perfectly with Biodesix's existing service offerings, as they already provide ctDNA testing as part of their Development Services portfolio.

Notably, Biodesix is exploring combining ctDNA with proteomics for molecular residual disease (MRD) detection - an approach that addresses the critical challenge of identifying remaining cancer cells after treatment. This strategic direction targets a growing segment of cancer diagnostics focused on treatment monitoring and recurrence detection.

While this research strengthens Biodesix's scientific credibility in liquid biopsy diagnostics, the publication represents validation of existing approaches rather than announcing new products or commercial milestones.

Research expands ctDNA monitoring applications to more cancer types and treatments, validating Biodesix's approach without immediate clinical implementation.

This research significantly broadens the potential clinical utility of circulating tumor DNA (ctDNA) monitoring beyond the previously established applications in advanced non-small cell lung cancer. By expanding to additional solid tumor types and patients treated with tyrosine kinase inhibitors, the study demonstrates the versatility of this liquid biopsy approach across different cancer contexts.

The consistent finding of a strong association between ctDNA changes and overall survival addresses a major clinical challenge in oncology - the need for earlier treatment response assessment. Current standard-of-care relies heavily on imaging studies that typically require months to determine efficacy, potentially delaying crucial treatment modifications.

From a drug development perspective, this validation could support using ctDNA as an early efficacy biomarker in clinical trials, potentially accelerating therapeutic development timelines. The collaboration's breadth - involving industry, government, academia, and advocacy groups through Friends of Cancer Research - lends substantial credibility to these findings.

Biodesix's exploration of combining ctDNA with proteomics for molecular residual disease detection represents a sophisticated approach to post-treatment monitoring. This technique could potentially offer greater sensitivity than either approach alone for detecting minimal remaining disease.

While scientifically significant, the research doesn't specify timelines for clinical implementation or regulatory pathways, representing ongoing scientific progress rather than immediate clinical practice change.

Aggregate analysis of eight clinical trials of patients with advanced non-small cell lung cancer (aNSCLC) was supported by Biodesix, using Bio-Rad Droplet Digital™ PCR technology

LOUISVILLE, Colo. and HERCULES, Calif., April 23, 2025 (GLOBE NEWSWIRE) -- Biodesix, Inc (Nasdaq: BDSX), a leading diagnostics solutions company, and Bio-Rad Laboratories (NYSE: BIO), a global leader in life science research and diagnostics products, contributed to new research findings from Friends of Cancer Research’s (Friends’) ctMoniTR Project, recently published in Clinical Cancer Research (CCR). The findings demonstrate a strong association between changes in levels of circulating tumor DNA (ctDNA) and treatment outcomes, offering the potential for integration of ctDNA analysis in therapeutic development programs, and clinical cancer care.

The ctMoniTR Project (ctDNA to Monitor Treatment Response) was designed to determine whether changes in levels of ctDNA predict treatment outcomes for patients. Results from the first phase of the project demonstrated a strong link between changes in ctDNA and overall survival in patients with aNSCLC treated with immune checkpoint inhibitors (published in the Journal of Clinical Oncology). The new data, from the second phase of ctMoniTR, expands the analysis to additional solid tumor types and treatment categories, including patients treated with tyrosine kinase inhibitors.

Led by Friends, collaborators included Biodesix alongside organizations from industry, government, academia, and advocacy groups. Biodesix contributed data generated using Bio-Rad Droplet Digital™ PCR (ddPCR™) * technology to detect ctDNA from patient samples.

“Biodesix is proud to be a partner on this important project, which has the potential to support a transformation of therapeutic development and clinical cancer care,” said Gary Pestano, PhD, Chief Development Officer at Biodesix. “The ctMoniTR Project is aligned with the mission and vision of Biodesix Development Services, as we strive to challenge the science and solutions of today, in order to evolve and adapt clinical decision-making to improve patient care and outcomes.”

“We are very pleased that Droplet Digital™ PCR (ddPCR™) was selected for use within this study,” said Steve Kulisch, Vice President Product Management, Digital Biology Group, Bio-Rad Laboratories. “These collaborations and research programs are vital as we work towards establishing novel methods for molecular residual disease monitoring in oncology, supporting the advancement of scientific research and ultimately healthcare.”

Beyond this specific research project, Biodesix offers ctDNA testing, using ddPCR technology, as part of its Development Services portfolio and is also exploring ctDNA in combination with proteomics to detect molecular residual disease (MRD). The latest advancements in this application will be presented at the American Association for Cancer Research (AACR) Annual Meeting, April 28th, 2025.

*Droplet Digital and ddPCR are trademarks of Bio-Rad Laboratories, Inc.

Media Contacts:
Biodesix, Inc.
Natalie St. Denis, Director Corporate Communications
+1 720-925-9285
Natalie.stdenis@biodesix.com

Bio-Rad Laboratories, Inc.
Katrina Academia, Inbound Marketing Manager
+1 510-356-7909
Katrina_academia@bio-rad.com

Zyme Communications (Bio-Rad PR firm)
Dr. Maria Spyrou
+44 (0) 7707 049 640
maria.spyrou@zymecommunications.com

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About Biodesix

Biodesix, Inc. (Nasdaq: BDSX) is a leading diagnostic solutions company, driven to improve clinical care and outcomes for patients. Biodesix Diagnostic Tests, including 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 across disease states. For more information, visit biodesix.com.

About Bio-Rad

Bio-Rad Laboratories, Inc. (NYSE: BIO and BIO.B) is a leader in developing, manufacturing, and marketing a broad range of products for the life science research and clinical diagnostics markets. Based in Hercules, California, Bio-Rad operates a global network of research, development, manufacturing, and sales operations with approximately 7,700 employees and $2.7 billion in revenues in 2023. Our customers include universities, research institutions, hospitals, and biopharmaceutical companies, as well as clinical, food safety and environmental quality laboratories. Together, we develop innovative, high-quality products that advance science and save lives. To learn more, visit bio-rad.com.

Forward-Looking Statements

This release may be deemed to contain certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, without limitation, statements we make regarding our products and our expectations about our products. Forward-looking statements generally can be identified by the use of forward-looking terminology such as "plan", "believe," "expect," "anticipate," "may," "will," "intend," "estimate," "continue," or similar expressions or the negative of those terms or expressions, although not all forward-looking statements contain these words. Such statements involve risks and uncertainties, which could cause actual results to vary materially from those expressed in or indicated by the forward-looking statements. These risks and uncertainties include global economic and geopolitical conditions, our ability to develop and market new or improved products, our ability to compete effectively, international legal and regulatory risks, supply chain risks, and product quality and liability issues. For further information regarding our risks and uncertainties, please refer to the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operation" in both Biodesix and Bio-Rad's public reports filed with the Securities and Exchange Commission, including our most recent Annual Reports on Form 10-K and our Quarterly Reports on Form 10-Q. Biodesix and Bio-Rad caution you not to place undue reliance on forward-looking statements, which reflect an analysis only and speak only as of the date hereof. We disclaim any obligation to update these forward-looking statements.


FAQ

What are the key findings of the ctMoniTR Project involving Biodesix (BDSX)?

The research demonstrated a strong association between changes in circulating tumor DNA (ctDNA) levels and treatment outcomes in cancer patients, particularly in advanced non-small cell lung cancer (aNSCLC) and other solid tumor types.

How is Biodesix (BDSX) utilizing ctDNA technology in cancer treatment?

Biodesix offers ctDNA testing using Bio-Rad's Droplet Digital PCR technology and is exploring its combination with proteomics for molecular residual disease detection.

What will Biodesix (BDSX) present at the AACR Annual Meeting in April 2025?

Biodesix will present their latest advancements in combining ctDNA with proteomics for molecular residual disease (MRD) detection.

What types of cancer patients were included in the Biodesix (BDSX) ctMoniTR study?

The study included patients with advanced non-small cell lung cancer (aNSCLC) and expanded to additional solid tumor types, including those treated with tyrosine kinase inhibitors.
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