October 29, 2025 | Pangaea launches its next-generation platform; EpiSign launches its Methylation-based Episignature Testing and Reference-based Interpretation & Classification (METRIC); Biodesix signs an expanded partnership agreement with Bio-Rad Laboratories; and more.
Biodesix has signed an expanded partnership agreement with Bio-Rad Laboratories, under which Biodesix will conduct the development, clinical validation, and regulatory submissions of in vitro diagnostic assays to enable highly sensitive detection of multiple genomic markers focused on oncology applications. Following regulatory clearance, Biodesix will manufacture and distribute dedicated specimen collection kits for the developed assays. Press release.
EpiSign launched Methylation-based Episignature Testing and Reference-based Interpretation & Classification (METRIC). The platform provides a fast, standardized approach for interpreting methylation profiles across a broad range of clinical indications. METRIC integrates with existing hardware and software systems while connecting users to EpiSign's comprehensive epigenomic database. Powered by AI algorithms, the secure cloud-based platform enables users to autonomously access and interpret patients' DNA methylation data, which enhances efficiency and turnaround times. Press release.
Thermo Fisher Scientific has entered a collaboration with OpenAI. This collaboration will help to improve the speed and success of drug development, enabling customers to get medicines to patients faster and more cost effectively. As part of this collaboration, Thermo Fisher is embedding OpenAI Application Programming Interfaces into critical areas of its business, ranging from product development, service delivery, customer engagement and operational efficiency. Press release.
Thermo Fisher Scientific has also introduced a new laboratory developed test for post-transplant biopsy assessment designed to improve the detection of lung transplant rejection and injury. The Molecular Microscope Diagnostic System for Lung leverages the power of machine learning to profile gene expression data from lung biopsies, comparing each new sample to a reference set of over 896 lung biopsies. The system assesses the probability of rejection and provides molecular scores associated with injury, graft dysfunction, and rejection. The results may aid in a pathologist’s assessment, with the aim of enabling greater confidence in the diagnosis and treatment of a lung transplant recipient. Press release.
IMVARIA released their new platform Bronchosolve, an AI-powered diagnostic solution for assessment of suspicious pulmonary nodules, met the primary endpoints in the VIRTUAL-BRONCH Study, demonstrating significant improvement in the ability to diagnose lung cancer non-invasively. Bronchosolve is a completely automated, end-to-end platform with a streamlined workflow and doesn’t need manual data and imaging manipulation. Press release.
Pangaea launched its next-generation platform, which is designed to help clinicians close care gaps, find untreated and sub-optimally treated patients, and drive real improvement in patient outcomes, all with reduced costs and increased revenues for health systems. Pangaea’s platform has been deployed across 13 countries and uses proven capabilities to flag patients who are missing for appropriate screening or treatments, despite relevant data being present in their records. This will enable earlier diagnosis and more effective triaging of hard-to-diagnose conditions, as well as helping health systems deliver more efficient care for better patient outcomes. Press release.
Bio-Techne Corporation announced a significant enhancement to its agreement with Oxford Nanopore. The expanded agreement broadens Bio-Techne's ability to develop a portfolio of genetic products on Oxford Nanopore platforms and extends the collaboration through 2032. Building upon the successful launch of the AmplideX Nanopore Carrier Plus Kit in March 2025, the collaboration streamlines coordination on the development and commercialization of a broader portfolio of targeted enrichment sequencing kits for the screening and diagnosis of heritable genetic disorders. Press release.
GeneDX announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its whole genome and exome tests associated with causes of life-threatening diseases or genetic disorders to aid in diagnosis of symptomatic patients. FDA Breakthrough Device Designation is reserved for technologies that have demonstrated the potential to provide more effective diagnosis or treatment for life-threatening or irreversibly debilitating diseases. The designation provides GeneDx with an expedited pathway for FDA review, including prioritized feedback and closer collaboration with the agency, designed to accelerate the availability of safe and effective innovative diagnostic devices for patients in all 50 states. Press release.
GeneDx also announced the Autism Partnership Program to expand access to its industry leading exome and genome testing, the only autism testing program committed to delivering answers to families in weeks. Jaguar Gene Therapy joins the program as the founding partner, initiating a genetic testing program for individuals clinically suspected of having SHANK3-related autism spectrum disorder and Phelan-McDermid syndrome. The Autism Partnership Program aims to unite healthcare providers, advocacy groups, biopharmaceutical companies and payers, as well as eliminate barriers to testing and deliver clinically actionable insights earlier in the diagnostic process. Press release.
A team from RMIT University and Nexsen Limited have signed a $732,000 (AUD $1.125 million) research contract to develop point-of-care tests—based on their established platform technology—to identify acute kidney injury hours faster than current methods and to allow chronic kidney disease monitoring at home for the first time. Press release.
The START Center for Cancer Research (START), its preclinical division XenoSTART, and Minerva Imaging announced an expansion of their decade-long partnership to establish the industry's most comprehensive integrated platform for radiopharmaceutical drug development. This collaboration unites XenoSTART's repository of clinically annotated patient-derived xenograft models with Minerva Imaging's advanced molecular imaging and radionuclide therapy expertise, creating a single-source solution spanning discovery, translational research, and manufacturing. Press release.
Revvity announced a program for expansion of its type 1 diabetes (T1D) offering to include a population-scale assay for early detection with support from Sanofi. Revvity will develop a T1D 4-plex in vitro diagnostic assay based on its existing research-use 3-plex assay. The collaboration supports clinical validation and regulatory submissions of the new T1D 4-plex assay on Revvity’s GSP instrument using capillary dried blood spot and venous specimens. The GSP instrument’s high throughput capability enables population-level screening for early-stage T1D in clinical practice, an important advance in the evolution of the standard of care. Regulatory submissions are planned for the U.S. FDA, IVDR, and other major jurisdictions. Press release.
MiraDx announced that its PROSTOX ultra test is now available for ordering in the United States. The test is a clinically validated genetic test that identifies patients with localized prostate cancer at higher risk of developing late genitourinary toxicity—urinary side effects such as urgency, leakage, or discomfort that may occur after treatment—with stereotactic body radiation therapy. It has already helped over 3,500 patients as part of an Early Access Program involving select academic centers and private practices. Press release.
Ambry Genetics, now a wholly owned subsidiary of Tempus AI, announced an enhancement to the Ambry CARE Program (CARE), Ambry's digital platform that streamlines cancer risk assessment and genetic testing workflows. The update integrates breast density into the Tyrer-Cuzick breast cancer risk score within the electronic health record, providing clinicians with more precise and personalized risk estimates at the point of care that can guide recommendations for breast cancer screening and risk reduction. Press release.
Mindpeak announced the European launch of PhenoScout AI, its advanced multiplex immunofluorescence (mIF) analysis solution. Developed with support of ZEISS and other industry partners, PhenoScout AI uses Mindpeak’s proprietary mIF algorithms to deliver actionable insights and spatial biology data with speed and reproducibility. By eliminating manual inefficiencies and enabling automated analysis of complex tissue samples, the platform accelerates biomarker discovery, standardized translational research, and advances the future of precision diagnostics. Press release.