The SARS-CoV-2 virus has now had ample time to mutate, as reports of the proliferation of multiple variants make clear, and the U.S. FDA’s Tim Stenzel said the agency is now focused on three variants, including one recently reported from Israel. Stenzel said on the latest COVID-19 testing town hall that one of the key concerns regarding existing authorized tests is the potential for loss of sensitivity, a problem the agency hopes to overcome without the use of live virus.

A Swiss diagnostics company is looking to tap into China’s vast patient pool to validate its diagnostic test for prostate cancer. Schlieren-based Proteomedix AG inked a partnership with Zhengzhou University Henan Cancer Hospital in China to validate its Proclarix diagnostics test in the local population.

Abbott Laboratories reported 2020 fourth-quarter revenue up 29% year over year to $10.7 billion, outpacing the consensus estimate of $764 million. The positive growth was largely fueled by sales in diagnostics, which surged 111% to $4.35 billion, from $2.10 billion in the prior year period. Net earnings for the period totaled $2.16 billion, or $1.20 per share, up from $1.5 billion, or $.59 per share a year ago. Adjusted earnings per share (EPS) was $1.45, ahead of the Street target of $1.35.

Driving to a laboratory for blood testing may soon be a thing of the past. Babson Diagnostics Inc. just completed a pivotal study of its new system for collecting and analyzing blood from a finger prick at a pharmacy counter. The results indicate that the microsample system provides comparable results to phlebotomist-drawn venipuncture blood samples.

The implementation date for the European Union’s In Vitro Diagnostic Regulation (IVDR) is a mere 16 months away, although there is widespread interest in a delayed implementation date. Nonetheless, Warren Jameson, principal regulatory consultant for North American Science Associates (NAMSA) of Toledo, Ohio, urged test makers to conduct a gap analysis of the conformity of their currently marketed tests to the new regulations because a large percentage of the underlying dossiers would not pass muster under the terms of the new regulatory regime.

HONG KONG – South Korea’s Ministry of Food and Drug Safety (MFDS) has greenlighted Seoul-based Vuno Inc.’s artificial intelligence (AI)-based solution Vuno Med Deepbrain for use as a class III medical device, which is a classification for moderate risk level devices. The MFDS approval was given on Dec. 29, 2021, a Vuno spokesperson told BioWorld, but the company only disclosed the approval earlier in the week. The reasons for the delayed announcement were not disclosed.

A green light from the U.S. FDA has significantly brightened Seno Medical Instruments Inc.’s image of its immediate future. The San Antonio-based company developed a novel breast cancer imaging technology that combines noninvasive opto-acoustic (OA) technology with ultrasound (US) to more accurately distinguish benign from malignant breast lesions following ambiguous mammography results.

The U.S. Department of Health and Human Services (HHS) has awarded a contract for validation of lab-developed tests (LDTs) for the pandemic to a private company, a move that was apparently an effort to address the resource crunch at the U.S.

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.