GC Genome Corp. priced a Kosdaq offering of 4 million shares at ₩10,500 per share May 27, entailing a gross ₩42 billion (US$30.5 million) raise in early June. The Yongin, South Korea-based genomics subsidiary of GC Biopharma Corp. fixed its shares price to the top of its ₩9,000 to ₩15,000 price band May 27 after conducting demand forecasting on domestic and international institutional investors from May 19 to May 23.
The U.S. FDA approved the PMA application for the Shield test by Guardant Health Inc., a diagnostic for colorectal cancer that avoids some of the issues with alternative diagnostic methods. There are lingering questions about Medicare coverage and physician adoption, however, the answers to which may take a couple of years emerge.
The U.S. FDA’s May 23 advisory hearing for the Shield test for colorectal cancer by Guardant Health Inc., included the expected debate over whether patients would abandon colonoscopy thanks to the advent of a new blood-based test. While much of that debate was fed by what some saw as the test’s poor performance regarding adenoma, the advisory committee voted 6-3 that the benefits outweigh the risks in a decision the FDA is likely to affirm.
If Freenome Holdings Inc.’s $254 million funding round is a sign, the capital markets for med-tech may finally be thawing. The cancer diagnostics company’s latest cash infusion brings its total funds raised to date to more than $1.3 billion. Freenome co-founder and Chief Product Officer Riley Ennis told BioWorld the company’s success in raising cash in a challenging market was attributable to the “perfect storm of huge unmet need and the opportunity that we have, given the treatment advancements.”
Elypta AB has devised new multi-cancer early detection technology leveraging plasma and urine glycosaminoglycans which can detect more than a dozen types of cancer in adults showing no symptoms.
Research led by Chalmers University of Technology and the Karolinska Institute in Sweden shows that glycosaminoglycans in the blood and urine can be used to detect 14 early-stage cancers.
Pharus Diagnostics Inc. emerged from stealth mode to streamline precision medicine-based cancer screening with its new multi-cancer early detection liquid biopsy test. Spun out from Hsinchu, Taiwan-based Quark Biosciences Taiwan Inc. in July 2022, Pharus is developing solutions to detect cancer early via Oncosweep, its multi-cancer early detection (MCED) liquid biopsy test that evaluates microRNA (miRNA) within the body.
The European Commission (EC) is proposing a novel cancer screening program that would improve cancer outcomes by fostering more frequent cancer screenings among European Union (EU) member nations. The primary focus is on screening for breast, cervical and colorectal cancers, but the plan carries a lofty target of providing screening services for 90% of those who qualify for screening.
Inoviq Ltd. and The University of Queensland (UQ) are expanding a collaboration to develop an exosome-based ovarian cancer screening test. Researchers from UQ identified and validated exosomal protein and micro-RNA (miRNA) biomarkers that when combined in its OCRF-7 algorithm showed more than 90% accuracy to detect stages I and II ovarian cancer in an independent 500-sample retrospective case-control study, Inoviq CEO Leearne Hinch told BioWorld.
Truscreen Group Ltd. completed its largest clinical trial to date that showed its cervical cancer screening device surpassed liquid-based cytology (LBC) screening in 15,651 women across 64 hospitals in nine provinces in China over three years.
