Reports of multiple new variants of the SARS-CoV-2 virus have emerged, raising questions about the efficacy of vaccines, but also regarding the utility of diagnostic and other tests. The U.S. FDA’s Tim Stenzel said single-target tests are thus at a greater risk of returning a false negative result, adding that these developers “should consider this carefully” in surveillance of their tests.

Diagnostics innovator Renalytix AI plc and dialysis giant Davita Inc. partnered to develop a program to identify individuals with early-stage kidney disease and improve outcomes for the 37 million Americans with chronic kidney disease (CKD). The companies plan to launch the collaborative effort in three cities in 2021 to build a diverse, real-world evidence dataset as a base for moving forward.

LONDON – The U.K. has launched a nationwide free testing program to diagnose COVID-19 in people who are asymptomatic, in the latest attempt to stem the tide of infection. Through the program, all local authorities will provide rapid testing using lateral flow devices. In addition, companies will be provided with free tests to set up workplace screening. Initially, the focus of both strands will be on getting people who cannot work from home to come forward for regular checks.

Helix Opco LLC, a company specializing in population genomics, has received de novo marketing authorization from the U.S. FDA for its whole exome sequencing platform, which covers roughly 20,000 genes. The San Mateo, Calif.-based company also picked up 510(k) clearance from the FDA for the first test to run on the Helix Laboratory Platform, a genetic health risk application for late-onset Alzheimer’s disease. That test has been cleared for over-the-counter use in conjunction with the Helix Laboratory Platform.

Pharmaceutical pain management has aided billions of patients, but has also created millions of cases of addiction, a problem that is driving research into pain. Omowunmi Sadik of the New Jersey Institutes of Technology, said on a recent webinar that the Biosensor Materials for Advanced Research & Technology (BioSMART) Center, is working on a suite of biosensors that may aid in the detection of the molecular markers associated with pain.

NEW DELHI – India, which has the highest incidence of tuberculosis (TB) in the world and the second highest of COVID-19, is looking to artificial intelligence (AI) to help detect and classify cases of both and lower the cost of diagnosis.

Ultromics Ltd. received U.S. FDA 510(k) clearance for its artificial intelligence-driven decision support tool for the diagnosis of coronary artery disease (CAD). Used in conjunction with a clinician's assessment, Echogo Pro's algorithms improve disease prediction and support more accurate diagnosis. Echogo Pro is a stress-Echo module in the Oxford, U.K.-based company's Echogo suite for CAD diagnosis.

Just a week into 2021 and Hologic Inc. is planning another acquisition. The company announced that it has agreed to acquire the molecular diagnostics testing company Biotheranostics Inc. for roughly $230 million cash up front. This comes on the heels of completing the acquisition of Somatex Medical Technologies GmbH for about $64 million. The acquisition of San Diego-based Biotheranostics is expected to close in February 2021, pending antitrust clearance.

Perkinelmer Inc. is aiming to boost its infectious disease testing footprint with the acquisition of Oxford Immunotec Global plc for $591 million in cash. The purchase, reported Thursday, will allow Perkinelmer to expand its current offerings with solutions for tuberculosis (TB) detection. Perkinelmer shares (NYSE:PKI) hit a high of $162.16 Thursday morning, before closing at $160.53 – up 2.66% from the Wednesday’s close of $156.37.