During the first round of discussion at its two-day hearing on a World Trade Organization proposal to expand the intellectual property (IP) waiver from COVID-19 vaccines to diagnostics and therapies, the U.S. International Trade Commission (USITC) got an earful from both sides of the debate.
The U.S. FDA gave Bot Image Inc. a coveted threefer with 510(k) clearance for its Prostatid artificial intelligence (AI) software for detection, diagnosis and monitoring of prostate cancer using both standard MRI and a non-invasive bi-parametric MRI, which does not require a contrast agent.
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.
Previous studies have identified a promising target and potential biomarker for diagnosing and treating gastrointestinal and esophageal cancers: claudin18.2 (CLDN18.2), a tight junction protein overexpressed in these and other solid tumors.
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.
Theranocure Co. Ltd. has divulged gadolinium complexes targeting β-amyloid protein acting as magnetic resonance imaging (MRI) contrast agents reported to be useful for the diagnosis of Alzheimer's disease and the treatment of Parkinson's and Alzheimer's disease.
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.
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