Biodesix Announces Progress In Two Collaborative Programs For Tumor-informed And Tumor-naïve Molecular Residual Disease Solutions

Biodesix, Inc. (NASDAQ:BDSX), a leading diagnostics solutions company, today announced strategic progress in two collaborative programs for tumor-informed and tumor-naïve Molecular Residual Disease (MRD) solutions intended to support cancer centers and clinical laboratories. Both solutions detect circulating tumor DNA (ctDNA), the tumor DNA that a cancer sheds into the blood, to assess whether disease remains or is returning after treatment. The tumor-informed solution is the result of a multi-year collaboration with Bio-Rad Laboratories. The tumor-naïve solution is a newly launched program with Thermo Fisher Scientific that extends a collaboration for companion diagnostic validation and other development work. Both approaches will be validated by Biodesix in collaboration with key investigators at Memorial Sloan Kettering Cancer Center (MSK) and are designed to run on partner platforms already installed in laboratories around the world."Our approach to MRD reflects a core conviction: sensitivity matters, and so does patient access. We are building ultra-sensitive assays with global collaborators whose platforms can carry those assays to laboratories and patients around the world," said Scott Hutton, Chief Executive Officer of Biodesix. "Offering both tumor-informed and tumor-naïve MRD means the clinical question can drive the testing strategy, rather than forcing a single approach in every situation. We believe this work positions Biodesix to participate in the growth of MRD testing well beyond the patients that can be reached through a centralized laboratory model."No single MRD approach serves every patient. Tumor-informed testing is generally the most sensitive option when tumor tissue is available, and tumor-naïve testing extends monitoring to patients whose tissue is unavailable or insufficient. Biodesix is advancing both, drawing on its proprietary Diagnostic Cortex® bioinformatics platform, its experience developing, validating, and commercializing diagnostic tests in its CAP-accredited, CLIA- and NYS CLEP-certified laboratory, and its track record in companion diagnostics test validation with global partners. The two programs build on MRD data that Biodesix and its collaborators have presented at scientific meetings over the past two years. Together they represent the first time Biodesix has outlined its MRD strategy as a whole and represents an expansion of the company’s focus beyond lung diagnostics into a rapidly growing area of precision oncology.Tumor-informed MRDFor the tumor-informed solution, Biodesix profiles a patient's tumor tissue using its proprietary Diagnostic Cortex® bioinformatics platform to identify multiple complex genomic changes unique to that individual. Bio-Rad’s Droplet Digital™ PCR technology is then used to track those changes in blood over the course of the patient's care, partitioning each sample into thousands of separate reactions so that individual tumor molecules can be counted. The ultra-sensitive informatics and analysis workflows detect ctDNA below 1 part per million (ppm) of the total DNA in a blood sample."Detecting molecular residual disease means finding a handful of molecules in a complex background, the precise application for which Droplet Digital PCR has an advantage over other technologies. Our multi-year work with Biodesix has focused on making that sensitivity practical in routine laboratories. We look forward to supporting broad access to these solutions and the positive impact they will have on patient lives," said Steve Kulisch, Vice President of Genomics Product Management, Bio-Rad Laboratories.Tumor-naïve MRDThe tumor-naïve solution detects methylated ctDNA in blood using rapid next-generation sequencing on the Genexus™ platform from Thermo Fisher Scientific. Biodesix has begun developing and validating this assay in its CAP-accredited, CLIA- and NYS CLEP-certified laboratory as part of the Thermo Fisher Center of Excellence Network. Because the method reads methylation patterns rather than mutations unique to an individual tumor, it requires no tumor tissue. This means the test can potentially help patients who otherwise would not have been eligible for an MRD test because their archived tissue is unavailable or insufficient."Methylation carries a rich biological signal, and rapid analytic and informatics workflows make it possible to act on that signal in a clinically relevant timeframe," said Gary Pestano, Ph.D., Chief Scientific Officer of Biodesix. "By providing both tumor-informed and tumor-naïve approaches, Biodesix can reach more of the patients who may benefit from molecular monitoring throughout their cancer journey."