April 30, 2025 | Cleveland Diagnostics announced the results of a new independent study published in Urology; Illumina and Tempus AI collaborate to accelerate clinical adoption of next-generation sequencing tests through novel evidence generation; LinusBio announced a new partnership with the BRAIN Foundation to support advancing autism biomarker research and facilitating early identification and intervention of autism spectrum disorder; and more.
Illumina and Tempus AI announced a collaboration to accelerate clinical adoption of next-generation sequencing tests through novel evidence generation. The collaboration will combine leading Illumina AI technologies with Tempus's comprehensive multimodal data platform to train genomic algorithms and ultimately accelerate clinical adoption of molecular testing for patients. This partnership will leverage Tempus multimodal data to further improve Illumina's AI-driven molecular analysis technologies and generate new insights supporting the clinical value of sequencing, which will be used to build evidence packages needed to standardize use of comprehensive genomic profiling and other molecular testing across all major diseases. Press release.
Cleveland Diagnostics announced the results of a new independent study published in Urology. The longitudinal study demonstrates the ability of the company’s IsoPSA prostate cancer test to help identify low-risk patients who can avoid or defer unnecessary interventions such as biopsy, while identifying high-risk patients who would benefit from closer monitoring. Prostate cancer remains the second most common cancer in American men, with one in every eight men diagnosed during their lifetime. IsoPSA is a highly accurate blood test that provides insight into patients’ elevated PSA levels by analyzing PSA protein structure to determine if the proteins may have originated in cancer cells. Press release.
Karius launched Karius Focus | BAL, a microbial cell-free DNA test that helps physicians accurately identify the pathogens causing pneumonia and other lung infections. The product became available nationwide on April 28, 2025. This test is designed to rapidly identify the etiology of lung infections and improve diagnostic yield over standard-of-care testing. With just 1 mL of BAL fluid, Karius Focus | BAL can detect and classify over 500 pathogens associated with lung infections—all within a single day of sample receipt. Press release.
Baylor Genetics announced their collaboration with the Child Neurology Society (CNS) as an official 2025-2026 genetic testing partner. Comprehensive genetic testing is an important step to ending long diagnostic journeys for patients and families facing neurodevelopmental disorders (NDD), epilepsy, and other neurological concerns. Baylor Genetics’ Neurodevelopmental Disorders Panel is designed for patients affected by a suspected or clinically diagnosed neurodevelopmental disorder, autism spectrum disorder, intellectual disability, and/or developmental delay. The partnership with the CNS is part of a broader commitment to improving access to genetic testing across the US. Press release.
Veracyte has launched its Decipher Prostate Metastatic Genomic Classifier for use in patients whose prostate cancer has spread beyond the primary tumor. The Decipher Prostate test is now the only gene expression test available and covered by Medicare to inform treatment decisions for patients across the full continuum of prostate cancer risk. Press release.
Mayo Clinic researchers have identified a potential new way to monitor the progression of high-grade gliomas, one of the most aggressive types of brain cancer. Their feasibility study suggests that a personalized blood test tailored to each patient's tumor DNA could provide a faster and less invasive way to determine if the cancer is advancing. Currently, clinicians rely on scans and surgical biopsies to monitor gliomas, but both methods have limitations. For example, scans often cannot distinguish tumor growth from treatment effects such as inflammation. Biopsies require invasive procedures, making them impractical for routine monitoring. This new approach may provide clinicians with another tool to monitor tumor changes over time and adjust treatment as needed. Press release.
Osaka Metropolitan University scientists have developed a light-induced DNA detection technique, using heterogeneous probe particles, that enables ultra-sensitive and ultra-fast genetic analysis without the need for PCR amplification. This advancement is lighting the way for faster, more affordable, and precise genetic analysis across medicine, environmental science, and portable diagnostics. Unlike PCR, which amplifies DNA sequences by making millions of copies of target DNA for detection, this method directly detects DNA by concentrating it and enhancing specificity through strong optical forces and photothermal effect. Press release.
BillionToOne announced that its comprehensive genomic profiling assay Northstar Select has met Medicare coverage criteria established by Palmetto GBA, a Medicare administrative contractor that administers the Molecular Diagnostics Services program (MolDx). This coverage, which was effective as of February 14, 2025, ensures Medicare beneficiaries will have access to BillionToOne's liquid biopsy test for cancer therapy selection. Northstar Select is an ultra-sensitive, 84-gene next-generation sequencing (NGS)-based ctDNA panel that helps oncologists identify genomic alterations in patients with advanced solid tumors to guide therapy selection. Press release.
Bruker announced a majority investment in RECIPE Chemicals + Instruments GmbH, based in Munich, Germany. RECIPE is a European provider of vendor-agnostic therapeutic drug monitoring (TDM) and other clinical in vitro diagnostic kits for LC-MS/MS, HPLC, and ICP-MS assays. The majority investment and strategic collaboration will enhance Bruker's capabilities in small molecule clinical diagnostic assays with RECIPE’s ClinMASS kits for Bruker’s EVOQ liquid chromatography triple-quadrupole mass spectrometers, as well as for LC-TQ-MS systems by other vendors. In addition, the companies are preparing the introduction of high-throughput, chromatography-free (‘chrom-free’) RECIPE ClinDART kits running on flexible EVOQ-DART TQ⁺ systems that can easily switch between established LC-TQ-MS methods, and the novel high-throughput ClinDART workflows. Press release.
RadNet and iCAD have entered into a definitive merger agreement under which RadNet will acquire iCAD in an all-stock transaction. The acquisition is intended to unite complementary leading AI-powered cancer detection and workflow solutions focused on improving the accuracy and early detection of breast cancer. With iCAD’s commercial and engineering team anticipated to join DeepHealth, RadNet’s wholly owned subsidiary, the combination is expected to accelerate RadNet’s growth and leadership in cancer screening and artificial intelligence. Following the completion of the acquisition, iCAD will be integrated into DeepHealth’s portfolio of solutions. Press release.
Vibrant Wellness has launched the Hormone Zoomer, an innovative wet urine test that gives integrative medicine professionals a comprehensive view of hormone health, endocrine disruption, and aging-related factors. The Hormone Zoomer analyzes how the body metabolizes hormones and identifying environmental toxins that may interfere with hormone function and receptor signaling. It uses clinically validated LC-MS/MS and GC-MS/MS methods for high-precision analysis and delivers detailed, clinically relevant insights to guide personalized care. Key advantages include comprehensive hormone metabolism profiling, endocrine disruption detection, bone and longevity insights, and more. Press release.
A new study led by the London School of Hygiene & Tropical Medicine (LSHTM) reveals the potential benefits of a simple $6 blood test for the protein troponin that could predict a person's risk of heart attacks and strokes with greater accuracy than ever before. High-sensitivity troponin blood tests are currently used in hospitals to diagnose heart attacks. LSHTM suggests also using the tests routinely to spot people who might be at increased risk of heart problems. Press release.
LinusBio announced a new partnership with the BRAIN Foundation to support their shared missions of advancing autism biomarker research and facilitating early identification and intervention of autism spectrum disorder (ASD). Both organizations will share knowledge and resources to advance research, increase awareness, and reduce barriers to achieving these goals. As part of this partnership, the BRAIN Foundation will facilitate academic collaborations for BRAIN-funded researchers to incorporate LinusBio’s proprietary temporal exposome sequencing platform into their studies. Press release.
Revvity announced that the US Food and Drug Administration (FDA) has approved the Auto-Pure 2400 liquid handling platform with the T-SPOT.TB test. Initially launched outside the US in 2024, this combination allows laboratories to improve productivity while maintaining clinical performance in latent tuberculosis (TB) detection. This milestone marks a significant advancement in the fight against TB with a faster high-throughput solution delivering accurate diagnostic results to support timely treatment and containment in the US, as well as other locations around the world. Press release.
Heranova Lifesciences announced the successful completion of Laboratory Developed Test (LDT) validation for HerResolve, a non-invasive diagnostic test designed to transform the management of endometriosis. HerResolve will initially be launched at selected clinical centers, with nationwide expansion planned to maximize patient accessibility in collaboration with commercial partners. Endometriosis has historically required invasive diagnostic procedures, which cause discomfort, risk, and distress for patients, as well as delayed diagnosis. HerResolve offers a new, non-invasive process designed to aid in diagnosis via a simple blood test capable of diagnostic accuracy that is equivalent to, or better than, the current gold standard. Leveraging clinically significant miRNA biomarkers, proprietary AI algorithms, and sophisticated bioinformatics, HerResolve translates complex medical data into clear, actionable “positive/negative” results. Press release.