Week in Review: FDA warns about Janssen COVID-19 vaccine | BD nabs green light for molecular STI panel | Lab co-owner indicted for COVID-19 testing fraud

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Dear LabPulse reader:

Earlier this week, the U.S. Food and Drug Administration (FDA) said it has revised a fact sheet and reissued an emergency use authorization (EUA) for the Janssen COVID-19 vaccine to include a warning about health risks. The warning states that reports of adverse events after use of the vaccine under the EUA suggest increased risks of myocarditis and pericarditis, particularly from zero through seven days following vaccination.

On Thursday, Becton Dickinson said the FDA has granted 510(k) clearance for the BD Vaginal Panel on the BD Cor molecular diagnostic system. The diagnostic test directly detects the three most common infectious causes of vaginitis using the firm’s high-throughput platform for large laboratories.

In other company news, PerkinElmer announced that it has completed the previously announced divestiture of its Applied, Food, and Enterprise Services businesses to New Mountain Capital. Werfen completed a $2 billion acquisition of Immucor, a privately held IVD company with a global presence in the transfusion and transplant markets. Bionano Laboratories expanded its clinical testing menu with the launch of two new tests based on optical genome mapping. And Biosynex extended the expiration time for a previously announced tender offer to purchase all shares of Hauppauge, NY-based Chembio Diagnostics.

Among the emerging technologies with promise to solve serious health issues, Amplified Sciences is developing a platform and tests for the early detection of pancreatic cancer and other diseases. Tests under development by the Purdue Research Foundation-affiliated startup use dyes to identify the potential for malignancy in fluid extracted from a cyst on the pancreas.

Meanwhile, in a study, researchers have evaluated a test that provides early detection for infants with homocystinuria (HCU) -- a rare inherited disease that, if not treated early, causes serious complications. Other researchers are developing a molecular point-of-care testing device that identifies individuals for whom hypnosis may relieve postoperative pain. The research, published earlier this year in The Journal of Molecular Diagnostics, may help reduce the use of opioids for pain management, the study investigators say. Separately, newly developed glow-in-the-dark proteins could make viral disease diagnosis quicker and easier, according to researchers in the Netherlands.

Like many others before him, a Chicago man, co-owner of a testing laboratory, has run into trouble for allegedly seeking improper reimbursement for COVID-19 testing. He has been indicted by a federal grand jury on 10 counts of wire fraud and one count of theft of government funds, the U.S. Attorney's Office, Northern District of Illinois, said on Tuesday.

Thank you for reading.

Leo O’Connor

Editor in Chief

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