LONDON – The first human challenge study of SARS-CoV-2 infection has reported initial results, showing it is safe to infect healthy volunteers with the virus in controlled conditions, and paving the way for the model to be used to accelerate clinical trials of COVID-19 vaccines, antivirals and diagnostics.

The availability of rapid antigen tests for the COVID-19 pandemic has been far short of ideal in recent weeks despite a recent order by the Biden administration for half a billion tests. The question of whether additional federal dollars are forthcoming for additional tests is up in the air, however, due to congressional concerns that there is roughly $800 million in unspent federal dollars, a signal that any additional monies might not be made available any time in the near term.

With the rates of nonalcoholic steatohepatitis (NASH) rapidly rising, Glympse Bio Inc. and Laboratory Corp. of America Holdings Inc. (Labcorp) have announced new tests that can assess the risk of the liver condition without the traditional biopsy.

A wearable biosensor developed by Scottish startup Pneumowave Ltd. has been tapped for a clinical trial investigating respiratory depression at King’s College London (KCL). Pneumowave’s respiratory monitoring platform will be used to collect breathing data from patients at risk of experiencing slow and shallow breathing as a side effect of opioid medication.

Molecular diagnostics could dramatically improve care for one of the most common infections women face, vaginitis. A study by Becton, Dickinson and Co. (BD) found that clinicians miss more than 45% of positive cases and misidentify an additional 12% of negative cases as positives when compared to diagnostic findings.

PARIS – Mikajaki SA reported the commercial launch of Eyelib, a robotic ophthalmic diagnostics platform. One year after obtaining CE marking, the Swiss-based med-tech is rolling out a wide-scale launch of its automatic ophthalmology examination system onto the European market.

Targetingone Corp. Ltd.’s new testing kit based on digital polymerase chain reaction (dPCR) techniques has received approval from China’s NMPA. It is the first dCPR-based testing kit to receive the country’s class III medical device registration certificate. The Beijing-based company collaborated with Tsinghua University, several hospitals and the Chinese Center for Disease Control and Prevention (CDC) participated to research and develop the testing kit.

Clinisys Inc. has signed a deal to buy laboratory information company Horizon Lab Systems LLC and combine Sunquest Information Systems under the Clinisys brand. The resulting group will be one of the world's largest laboratory informatics organizations. Clinisys and Sunquest share the same parent company – Roper Technologies Inc., which trades on the NYSE stock exchange. The addition of Raleigh, N.C.-based Horizon provides Clinisys with expertise in the public health, environmental, water quality, toxicology and agriculture markets.

Sema4 Holdings Corp. sent a bold message to the market with a definitive agreement to acquire Genedx Inc. from Opko Health Inc. for $623 million. The deal comes as Sema4 winds down its COVID-19 testing by the end of March. The company has been one of the largest testing organizations in Connecticut since its first contract in May 2020, but has lately come under scrutiny because of an investment by Annie Lamont, the governor’s wife.