The U.S. Federal Trade Commission (FTC) issued a final order in connection with the proposed reacquisition of Grail Inc. by Illumina Inc., in an action that might seem to finally conclude a matter that has stretched over several years. However, the FTC acknowledged that Illumina has 60 days to petition the order, which Illumina said it intends to do in conjunction with an effort to overturn a similarly adverse outcome in the EU.
Ixlayer Inc. expanded access to diabetes screening by offering its test via retailers, health systems and payers, making it easier for consumers to measure and track their blood glucose levels without requiring a doctor’s visit or prescription. If an individual’s test results indicate that they have or are at risk of developing diabetes, however, the company will offer to connect them with a health care provider available through the reseller’s network to discuss next steps.
Genialis Inc. reeled in $13 million in a series A financing co-led by Taiwania Capital and Debiopharm Innovation Fund. The funds will be used to build out the company’s store of clinically validated biomarker models for individualized cancer diagnosis.
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.
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