LONDON – Final results of the community pilot in Liverpool, U.K., that used the controversial Innova Medical Group Inc. lateral flow device to test all comers for COVID-19, show new cases fell by 21% compared to other areas of the U.K., because infections were detected early and people quarantined sooner.
GE Healthcare and Sophia Genetics SA partnered to develop new artificial intelligence (AI)-powered analytics and workflow solutions to improve patient matching with cancer therapies.
PERTH, Australia – Rapid point-of-care (POC) diagnostics company Lumos Diagnostics Holdings Ltd. completed a A$63 million (US$47.44 million) initial public offering (IPO) on the Australian Securities Exchange (ASX) on July 5. “The funds raised will support U.S. commercialization of Febridx, to build our pipeline and to expand our operations so that we have the facilities and infrastructure in place to do automated assembly and manufacturing,” Lumos Diagnostics CEO Rob Sambursky told BioWorld.
The U.S. National Institutes of Health (NIH) has waded into the controversial question of the respective roles of rapid antigen and polymerase chain reaction (PCR) tests for detection of the SARS-CoV-2 virus, a question that roiled relations between the FDA and public health experts. According to NIH, three rapid antigen tests administered at three-day intervals offer the same level of sensitivity as PCR, a finding that will likely make itself felt in future communicable disease outbreaks.
The FDA has given a green light to Foundation Medicine Inc.’s Foundationone CDx as a companion diagnostic for Takeda Pharmaceutical Co. Ltd.’s Alunbrig to identify patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small-cell lung cancer (NSCLC). The approval comes as Laboratory Corp. of America Holdings (Labcorp) is launching a companion diagnostic to identify NSCLC patients with the KRAS mutation. NSCLC accounts for about 85% of all lung cancers, with an estimated 1.8 million new cases diagnosed each year worldwide. Of those, 3% to 5% carry the ALK gene mutation, which is often missed with standard testing methods.
PERTH, Australia – With FDA approval of its Guardian system to detect early heart attacks, Angel Medical Systems Inc. (Angelmed) will launch the device in the next six weeks in the U.S., and partner Hydrix Ltd. will launch the devices in eight Asia Pacific markets.
Looking to allow customers to directly purchase its diagnostics system that runs a full panel of blood tests, Babson Diagnostics Inc. raised $31 million in new series B financing. The proceeds will be used to scale the Austin, Texas-based company to bring its finger-prick blood microsampling system to retail locations across the country.
An artificial intelligence (AI)-powered tool invented by researchers from a trio of Singaporean institutions could speed up the diagnosis of cardiovascular diseases. The innovation uses electrocardiograms (ECGs) to diagnose coronary artery disease, myocardial infarction and congestive heart failure.
As the first flagship action of Europe’s plan to beat cancer, the European Commission launched its Cancer Knowledge Center June 30. The new online platform will map the latest evidence on cancer, provide health care guidelines and quality assurance schemes, and monitor and project trends in cancer incidence and mortality across the EU, where cancer is the No. 1 killer for people younger than 65.
Mfb Fertility Inc. received CE mark approval for its Proov PdG tests, giving European women direct access to information about ovulation without a prescription. The test enables a woman to test her urine for production of sufficient progesterone to confirm ovulation and favorable conditions for conception.
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