Case Western Reserve University and Hemex Health are developing a rapid, noninvasive chairside oral cancer test, supported by a $2.93 million NIH grant, aiming to reduce unnecessary biopsies and enable point-of-care diagnostics.
Concert has issued a coverage policy deeming the EsoGuard Esophageal DNA Test medically necessary for eligible patients, with multiple client health plans now adopting the policy.
A Cedars-Sinai study in JAMA Network Open reports women testing negative for BRCA mutations but with a family cancer history face a 25% lifetime breast cancer risk, underscoring the importance of family history in risk assessment.
The company is showcasing newly cleared tests and platforms for multiple myeloma, lung cancer, connective tissue disease, and other laboratory applications.
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Researchers report that inherited CDK12 gene variants may increase risk for early, aggressive prostate cancer, suggesting inclusion of CDK12 in hereditary screening panels could improve risk identification in men.
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Ibex Medical Analytics has received IVDR certification for its breast cancer diagnostic tools, completing regulatory approval for ER, PR, and Ki67 tests, according to a company press release.
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The test uses intact circulating tumor cells instead of cell-free DNA fragments to analyze more than 500 genes and identify tumor markers.
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The assay is designed to detect minimal residual disease with greater sensitivity than conventional flow cytometry.
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A new study in The Journal of Nuclear Medicine reports that a noninvasive DNA blood test can help select advanced prostate cancer patients most likely to benefit from 223Ra radiopharmaceutical therapy and monitor treatment response.
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The deal adds a blood-based test for viral-mediated cancers to the company’s portfolio of transplant and cell therapy services.
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A multi-center study found that AI-assisted prostate biopsy review improved diagnostic consistency, reduced lab workloads, and cut turnaround times by nearly a day in UK NHS pathology labs.
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A Kanazawa University study found that a blood-based gene expression test detected 90% of early-stage pancreatic cancer cases, outperforming CA19-9, which identified only 10%.
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A3P Biomedical’s Stockholm3 test showed 90% sensitivity in detecting aggressive prostate cancer in a study of 12,670 men, outperforming traditional PSA screening.
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Researchers identified coordinated lipid, metabolite, and protein signatures in symptomatic patients, supporting a multi-omic strategy for earlier ovarian cancer detection.
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Spotlight Medical’s myStage Dx AI breast cancer test has received CE marking under EU IVDR, enabling adoption in European oncology and pathology labs for recurrence risk assessment in ER+/HER2- early breast cancer patients.
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Freenome’s updated SimpleScreen CRC blood test met all primary and secondary endpoints in clinical validation, with improved sensitivity for precancerous lesions and colorectal cancer.
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A highly sensitive blood test for KRAS mutations detected pancreatic cancer recurrence in more patients than standard methods, according to Northwestern Medicine research.
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NeoGenomics has launched the first FDA-approved PTEN IHC companion diagnostic for prostate adenocarcinoma, enabling identification of patients with PTEN deficiency who may benefit from AstraZeneca’s capivasertib therapy.
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