Lexagene Holdings Inc. has successfully configured its Miqlab system to detect the U.K. and South African variants of SARS-CoV-2. The open-access point-of-care system can simultaneously screen for multiple respiratory pathogens and identify COVID-19 strains. Lexagene started studies to support its filing for U.S. FDA emergency use authorization (EUA) in late December 2020. If authorized, it would be the first open-access point-of-care (POC) device to gain an EUA.
Infectious diseases diagnostics company Lucira Health Inc. launched an IPO of 9 million shares of common stock at $17 per share, for expected gross proceeds of $153 million. Friday’s Wall Street debut was a show of confidence, upsized from an original plan to offer 7.8 million shares at $15 to $17. The Emeryville, Calif.-based company has granted the underwriters a 30-day option to acquire up to an additional 1,350,000 shares of common stock at the initial public offering price, less underwriting discounts and commissions.
Visby Medical Inc. secured $12.3 million in funding from the U.S. Biomedical Advanced Research and Development Authority (BARDA) to develop a next generation device to detect influenza and COVID-19 in a single point-of-care rapid PCR test and, subsequently, as an over-the-counter test for consumer use. The contract may be extended up to a total of $48.7 million over a period of 38 months based on meeting certain milestones in the base period, according to Visby Founder and CEO Adam de la Zerda.
Thermo Fisher Scientific Inc. has inked a definitive agreement to acquire Mesa Biotech Inc., a privately held molecular diagnostics company with a point-of-care (POC) platform, for approximately $450 million in cash. The scientific instruments and testing giant said it will pay an additional $100 million in cash upon the completion of certain milestones. The planned acquisition will expand Thermo Fisher’s franchise of diagnostic test options with a novel platform that enables nucleic acid polymerase chain reaction (PCR) testing at the point of care.
Lexagene Holdings Inc. started a series of studies for submission to the U.S. FDA for emergency use authorization (EUA) for its point-of-care system and adaptable COVID-19 assay. The open-access technology enables rapid configuration for new COVID-19 variants.
TORONTO – Waterloo, Ontario-based health startup Kenota Inc. has raised $9 million in series A funding to develop an in-clinic allergy test that takes less than 30 minutes and requires only a few drops of blood from a mild finger prick. This brings the total investment to $11 million for a point-of-care system that detects antibodies signaling allergies to egg, milk and peanuts and that will eventually search out environmental allergies to bee stings and shellfish.
Clinics, urgent care centers, busy hospitals, and patients can count on Hemoscreen, a miniaturized point-of-care hematology analyzer made by Pixcell Medical Technologies Ltd., to provide accurate complete blood count (CBC) results, according to a study published in the Journal of Applied Laboratory Medicine. The study found the small unit better differentiates between cells and adapts to inference than conventional laboratory blood analysis.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA delays comment period for electromagnetic compatibility draft; CMS, ONC post info sharing, prior authorization rule; Van Hollen debuts diagnostic accuracy bill; CDC updates POC testing guidelines; GAO: Specimen biopsy handling errors relatively low.
PERTH, Australia – Gbs Inc. reported filing an initial public offering on the Nasdaq for $20 million, as the company looks to launch the first noninvasive SARS-Cov-2 test. A subsidiary of Sydney-based The Iq Group Ltd. (NSX:IQG), Delaware-based Gbs has developed a biosensor platform that enables real-time diagnostic point-of-care (POC) tests, and the funds raised will enable the company to launch its SARS- CoV-2 test and a saliva glucose test.
Lumos Diagnostics Holdings Pty. Ltd. scooped up AU$25 million (US$17.9 million) in an oversubscribed pre-IPO ahead of its anticipated 2021 listing on the Australian Securities Exchange (ASX). The funds will be used to expand manufacturing operations in California and Florida and to grow the commercial footprint of Febridx, a rapid point-of-care (POC) test that can determine if a person has a viral or bacterial infection within 10 minutes.