The dominoes are falling on European clinical trials as the unintended consequences of the EU’s In Vitro Diagnostics Regulation take hold. Last year’s implementation of the regulation has resulted in the delay of up to 160 drug trials to date, with as many as 420 trials expected to be delayed over the next three years, according to an EFPIA member survey.
The France Biotech business association released its latest annual survey covering the health-tech sector in France. According to the 2022 edition of the Panorama, 1,440 med-tech, 880 bio-tech and 4,000 health and artificial intelligence software companies have been surveyed, responsible between them for $1.4 billion in sales revenues and 14,000 direct jobs, not counting the 2,200 new jobs planned for 2023 mainly in R&D, production and support services.
Cardio Diagnostics Holding Inc. launched Precisionchd, a blood test for the early detection of coronary heart disease. The test will initially be available for existing customers, with nationwide rollout to follow shortly thereafter, the company said.
A cancer therapy test unveiled by Exact Sciences Corp. will be able to provide a complete molecular picture of a patient’s tumor allowing for them to receive the most effective treatment as quickly as possible. Exact’s Oncoextra therapy selection test, recently launched in the U.S., enhances the ability of doctors to characterize and understand solid tumors.
Epigenetic testing company Trudiagnostic LLC has linked up with Rejuve.AI, an artificial intelligence (AI)-powered longevity research network, to develop more accurate tools for predicting chronological age. Specifically, the collaboration seeks to shed new light on the biology of aging and connectedness of DNA methylation (DNAm), metabolomics and proteomics.
Any decision on whether to expand a five-year World Trade Organization (WTO) waiver of intellectual property rights for COVID-19 vaccines to diagnostics and therapies likely will be delayed longer than proponents had hoped. WTO members originally were scheduled to vote on expanding the waiver in December, but the deadline was extended indefinitely when key members, including the U.S., pushed for a delay.
Nervtex Co. Ltd.’s diagnostic assessment software Modas for movement disorders such as Parkinson’s disease has been given NMPA approval in China. Using smart mobile devices, Modas can process video data collected from people with potential or existing movement disorders when they are in any specific motion state.
Act Genomics (Hong Kong) Ltd. won U.S. FDA approval for its genomic profiling test for solid tumors, Actonco. This marks the first time an Asia-based company has received FDA clearance for a comprehensive genomic profiling test.
Nuralogix Corp. is taking its selfie-based health monitoring platform to the next level, offering continuous health and vital signs tracking during video calls. The launch of Anura Telehealth is the newest addition its Anura app, which uses video cameras on smartphones and other consumer devices to extract facial blood flow information and provide a personalized snapshot of health and wellness.
The U.S. FDA has approved Polarean Imaging plc’s drug-device combination product, Xenoview, for use with magnetic resonance imaging (MRI) in evaluating lung ventilation in adults and children aged 12 and older. The hyperpolarized contrast agent, which is prepared from the Xenon Xe 129 gas blend, is expected to be commercially available in the U.S. starting next month.
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