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Biodesix Expands MRD Testing With Tumor-Informed and Tumor-Naive Tests

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Key Takeaways

  • Biodesix is advancing tumor-informed and tumor-naive MRD programs for blood-based cancer monitoring.
  • BDSX's tumor-informed test uses Bio-Rad technology to detect ctDNA below 1 part per million.
  • Biodesix's tumor-naive assay uses Thermo Fisher's Genexus platform and does not require tumor tissue.

Biodesix (BDSX - Free Report) recently announced strategic progress in two molecular residual disease (MRD) programs to expand access to blood-based cancer monitoring. The company is developing tumor-informed and tumor-naive solutions that detect circulating tumor DNA (ctDNA), with the programs being advanced through collaborations with Bio-Rad Laboratories (BIO - Free Report) and Thermo Fisher Scientific (TMO - Free Report) .

Per management, the company is pursuing both MRD approaches to combine ultra-sensitive testing with broader patient access. Through collaborations with global partners, Biodesix is developing tumor-informed and tumor-naive assays that can be deployed across laboratories worldwide. Offering both approaches allows the testing strategy to be aligned with specific clinical needs, rather than relying on a single approach, while helping extend MRD testing to more patients beyond centralized laboratory settings.

BDSX Stock Trend Following the News

BDSX stock has lost 1% since the announcement on Thursday. Year to date, the stock skyrocketed 327.9%, outperforming the industry’s 5% growth and the S&P 500’s 12.6% gain.

Biodesix’s expansion into MRD testing could broaden its precision oncology opportunity beyond its existing focus on lung diagnostics. Leveraging established technologies from Bio-Rad Laboratories and Thermo Fisher Scientific could strengthen BDSX’s relevance among oncology-focused laboratories and biopharma customers. Successful validation and commercialization could also enhance the company’s ability to participate in larger diagnostic programs and diversify its revenue base. Upcoming clinical data readouts may provide further visibility into the commercial potential of these initiatives.

BDSX currently has a market capitalization of $307 million.

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More on Biodesix’s MRD Programs

Biodesix’s tumor-informed approach profiles a patient’s tumor tissue through its proprietary Diagnostic Cortex bioinformatics platform to identify multiple complex genomic alterations unique to the tumor. Bio-Rad Laboratories’ Droplet Digital PCR technology then tracks these alterations in blood samples by partitioning each blood sample into thousands of reactions to quantify individual tumor molecules. Biodesix’s informatics and analysis workflows can detect ctDNA at levels below 1 part per million of total DNA.

BDSX’s tumor-naive MRD program takes a different approach by detecting methylated ctDNA in blood through rapid next-generation sequencing on Thermo Fisher Scientific’s Genexus platform. Since it identifies methylation patterns rather than tumor-specific mutations, the test does not require tumor tissue. This expands MRD testing to patients whose archived tissue is unavailable or inadequate.

Biodesix has begun developing and validating the tumor-naive assay in its CAP-accredited, CLIA- and NYS CLEP-certified laboratory as part of the Thermo Fisher Center of Excellence Network.

Both MRD approaches will be validated in collaboration with investigators at Memorial Sloan Kettering Cancer Center and are designed to operate on partner platforms already installed in laboratories worldwide. Data supporting both programs are expected to be presented at the AMP 2026 Annual Meeting in November, with additional data planned for the San Antonio Breast Cancer Symposium in December.

Industry Prospects Favoring the Market

Going by the data provided by Grand View Research, the global MRD testing market is estimated to reach $3 billion in 2026 and is projected to expand at a 13.2% CAGR through 2033.

Factors such as the increasing adoption of MRD testing in precision oncology, advances in molecular diagnostics and growing use of MRD assessment in cancer treatment monitoring are supporting market growth.

BDSX’s Zacks Rank & Other Key Pick

Currently, Biodesix carries a Zacks Rank #2 (Buy).

One of the top-ranked stocks from the broader medical space is Veracyte (VCYT - Free Report) , currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Veracyte reported a second-quarter 2026 adjusted earnings of 54 cents per share, which surpassed the Zacks Consensus Estimate by 25.6%. Revenues of $150.3 million beat the Zacks Consensus Estimate by 4.1%.

VCYT has an estimated earnings growth rate of 8.4% for 2026. The company’s earnings beat estimates in each of the trailing four quarters, the average surprise being 41.8%.

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