Biodesix Recognized as a Thermo Fisher Scientific Center of Excellence (COE) for NGS Diagnostics

Rhea-AI Summary

Biodesix (Nasdaq: BDSX) has been designated as a Thermo Fisher Scientific Center of Excellence (COE) for NGS diagnostics. The company played a crucial role in validating Thermo Fisher's Oncomine Dx Express Test for solid tumors on the Genexus Dx Integrated Sequencer, which received FDA approval in July 2025.

Through its Development Services division, Biodesix provided validation studies and data generation support for regulatory submission using its design-controlled laboratory processes and quality management systems. The company aims to expand its molecular diagnostic and NGS testing capabilities in tissue-based profiling.

Biodesix will participate in upcoming presentations about the NGS precision oncology solution at the CAP TODAY webinar on August 27, 2025, and the College of American Pathologists Annual Meeting on September 15, 2025.

Positive

• Recognition as Thermo Fisher Scientific Center of Excellence enhances company's credibility
• Successful validation partnership led to FDA approval of Oncomine Dx Express Test
• Potential future offering of Oncomine Dx Express Test expands diagnostic capabilities

Negative

• None.

Biodesix recently validated Thermo Fisher’s tissue-based Oncomine Dx Express Test for solid tumors on the Genexus Dx Integrated Sequencer

LOUISVILLE, Colo., Aug. 19, 2025 (GLOBE NEWSWIRE) -- Biodesix, Inc. (Nasdaq: BDSX), a leader in personalized diagnostics, announced that the company is designated as a Thermo Fisher Scientific Center of Excellence (COE) as part of Thermo Fisher’s collaborative initiative to advance NGS-based diagnostics. The services provided to Thermo Fisher are an example of Biodesix Development Services offerings, including customizable options that enable the world’s leading life sciences companies, biopharmaceutical, and medical research institutions with scientific, technological, and operational capabilities.

As Thermo Fisher announced in July 2025, Biodesix was an instrumental partner in the validation of the Oncomine Dx Express Test leading to the FDA approval of the Genexus Dx Integrated Sequencer. Biodesix Development Services conducted validation studies utilizing its design-controlled laboratory processes, quality management systems, and contributed data generation in support of regulatory submission.

“Working with Thermo Fisher, we continue to forge a path to conquer cancer, and we are delighted to expand our molecular diagnostic and NGS testing capabilities in tissue-based profiling,” said Scott Hutton, CEO at Biodesix. "Being a member of Thermo Fisher’s COE network puts us in excellent company with other global groups committed to transforming cancer diagnosis and care. We are excited about the potential to offer the Oncomine Dx Express Test in the future.”

Upcoming presentations to learn more about the Thermo Fisher NGS precision oncology solution and how Biodesix will apply the science for its industry clients and healthcare professionals:

• August 27, 2025 | CAP TODAY | Thermo Fisher Scientific Webinar: Introduction of new FDA approved rapid NGS solution for Companion Diagnostics & tumor profiling in oncology. Speakers: David Chi, PhD, Thermo Fisher Scientific, Bence Sipos, MD, and Gary Pestano, PhD, Chief Development Officer, Biodesix
• September 15, 2025 | Orlando, FL | College of American Pathologists (CAP) 2025 Annual Meeting | Thermo Fisher-sponsored Panel: "Introduction of new IVD solution for rapid NGS profiling in Oncology". Speakers: Mahmoud Elsayad, MD, FCAP, University of Texas Health, Alison Roos, Thermo Fisher Scientific, and Gary Pestano, PhD, Chief Development Officer, Biodesix

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.

About the Thermo Fisher COE Network:
Thermo Fisher’s NGS COE Network partners with leading global institutions to develop, validate, and refine its Ion Torrent™ Oncomine™ solutions portfolio. Through these COEs, Thermo Fisher collaborates with experts to accelerate oncology research, foster strategic alliances, and advance precision medicine.

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 is Biodesix's new designation from Thermo Fisher Scientific?

Biodesix has been designated as a Center of Excellence (COE) for NGS diagnostics as part of Thermo Fisher's collaborative initiative to advance NGS-based diagnostics.

What role did Biodesix play in the Oncomine Dx Express Test validation?

Biodesix conducted validation studies using design-controlled laboratory processes and quality management systems, contributing data generation for regulatory submission that led to FDA approval of the test on the Genexus Dx Integrated Sequencer.

When will Biodesix present at the College of American Pathologists Annual Meeting?

Biodesix's Chief Development Officer Gary Pestano, PhD, will present at the CAP 2025 Annual Meeting on September 15, 2025 in Orlando, FL, as part of a Thermo Fisher-sponsored panel on rapid NGS profiling in Oncology.

How does this partnership benefit Biodesix's diagnostic capabilities?

The partnership enables Biodesix to expand its molecular diagnostic and NGS testing capabilities in tissue-based profiling, with the potential to offer the Oncomine Dx Express Test in the future.