Non-clinical testing for the SARS-CoV-2 virus has been a major goal for regulators across the globe for months. Emergency use authorization (EUA) was just granted by the FDA is for the Quidel Quickvue COVID-19 test, an at-home antigen test with a turnaround time of 10 minutes. It’s the latest in a series of approvals of home tests and collection kits that promises to help control the pandemic.
Hologic Inc. continues to strengthen its diagnostics businesses via tuck-ins, this time with the acquisition of Diagenode SA for $159 million. The Belgium-based developer of molecular assays and epigenetics products counts more than 30 real-time polymerase chain reaction (PCR) tests in its portfolio. Marlborough, Mass.-based Hologic has been on a spending spree in recent months. In January, the company completed the acquisition of Somatex Medical Technologies GmbH for about $64 million and agreed to buy molecular diagnostics company Biotheranostics Inc. for $230 million.
HONG KONG – Vuno Inc. saw its shares soar on their first day of trading on the Kosdaq board with a $33.4 million IPO. The shares closed at ₩32,150 (US$28.89) on Feb. 26. Vuno had priced the 1.8 million new shares on offer at ₩21,000, exceeding its desired range of ₩15,000 to ₩19,500 and raising ₩37.8 billion, or $33.4 million, to boot.
Truvian Sciences Inc. has closed more than $105 million in an oversubscribed series C financing round that will help jumpstart the evaluation of the company’s automated benchtop blood testing system. The round was led by TYH Ventures, Glen Tullman of 7wireventures, and Wittington Ventures.
Test developers and the U.S. FDA are scrambling to meet the testing needs of the American public, however, it's somewhat unclear what the agency's priorities are for the emergency use authorization (EUA) program. Jeffrey Shapiro, of Hyman Phelps & McNamara, made the case that the FDA’s Center for Devices and Radiological Health (CDRH) should be more transparent about its priorities for EUA review.
Adaptive Biotechnologies Corp. posted revenue of $30.2 million for the fourth quarter of 2020, up 25% from the corresponding prior year period. The tally beat consensus by $3.3 million. Clinical sequencing volume grew 41% to 4,539 clinical tests, compared with the fourth quarter of 2019. For the full year, revenue increased 16% year over year to $98.4 million, and clinical sequencing volume topped out at 15,216 clinical tests delivered, up 50%. The results coincided with the launch of the company’s T-Detect COVID, the first clinical T cell-based test to confirm recent or prior COVID-19 infection.
HONG KONG – Wuxi Diagnostic Investment (Cayman) Ltd. has raised $150 million in a series B financing round, while netting a number of new investors along the way. The new investors to come on board include Thermo Fisher Scientific Inc., Shiyu Capital, ABC International Holdings Ltd., Sunland Capital and CCBI Tech Venture.
Keeping you up to date on recent developments in diagnostics, including: Atherosclerosis precedes clonal hematopoiesis; AI-driven tool to assess kidney function; Deep learning-powered classification of lung cancer types.
The U.S FDA’s response to the pandemic has been all-consuming, but epidemiologist Michael Mina of Harvard blasted the agency’s handling of rapid testing. Mina said the agency is in possession of emergency use authorization filings for rapid antigen tests that should be acceptable, but that the FDA is “the only bottleneck” in the rapid antigen testing pipeline.
The National Institutes of Health selected Pixcell Medical Ltd.’s Hemoscreen hematology analyzer as part of the six-year Risk Underlying Rural Areas Longitudinal (RURAL) research study, aiming to gain insight into the specific health-related concerns of the rural southeastern United States' population. The RURAL study is funded by the National Heart, Lung and Blood Institute and aims to understand health concerns specific to rural communities in the South, particularly related to increased rates of heart, lung, blood and sleep disorders.
RSS
