Castle Biosciences Inc.'s Decisiondx Diffdx-Melanoma test is now commercially available to help dermatopathologists better characterize melanocytic lesions. About 15% of suspicious pigmented skin lesions cannot be definitively determined to be benign or malignant using common methods. The new gene expression profile test reduces the number of indeterminate results by more than 70%.
Illumina Inc. crushed analysts’ estimates for the third quarter, posting revenue of $794 million vs. the Street consensus of $716 million. Driving results were sequencing consumables, which racked up $500 million in the period, with clinical sequencing hitting 96% of pre-COVID-19 levels, up from 84% in the second quarter.
Precision oncology company Genetron Holdings Ltd. has entered an exclusive licensing agreement for Seq-MRD, a diagnostic assay for detecting and monitoring minimal residual disease (MRD) in select hematologic cancers from med-tech startup Hangzhou Immuquad Biotechnologies Co. Ltd.
TORONTO – Whether it’s President Trump obtaining the drug Regeneron or COVID-19 test kits fast tracked in the U.S. and Canada, this has been the year of temporary emergency approvals for drugs and medical devices. What is sometimes overlooked are permanent programs like Canada’s Special Access Program and the U.S.’s Expanded Access Program, designed to provide therapeutics to patients who have exhausted every avenue for a cure or relief from a devastating disease.
If a new federal rule withstands politics and potential court challenges, U.S. health care prices may finally be freed from their historic black box. The Centers for Medicare & Medicaid Services, along with the Departments of Labor and the Treasury, issued the Transparency in Coverage final rule Oct. 29 requiring most private health plans to disclose pricing and cost-sharing information so Americans will know in advance how much they will have to pay for prescription drugs, medical devices and other health care products and services.
Keeping you up to date on recent developments in diagnostics, including: A case for pooled testing of SARS-CoV-2; FIT as effective as colonoscopy in ruling out suspected colorectal cancer; Looking to comparative genomics analysis to explain COVID-19 susceptibility.
The U.S. FDA moved the goal posts for other companies with its expansion of the emergency use authorization for Helix Opco LLC’s COVID-19 test to include both unsupervised self-collection of samples and testing of asymptomatic individuals. The new indications promise to make the Helix test the preferred tool for schools, universities, and work settings by reducing costs and increasing flexibility.
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