North Korea’s admission that it is battling an “explosive” COVID-19 outbreak raised concerns that the virus could devastate a country with an under-resourced health system, limited testing capabilities, and no vaccine program.

The U.S. Food and Drug Administration on March 2 warned people against the use of unauthorized versions of certain COVID-19 rapid antigen tests currently being marketed in the United States.

U.S. health officials said on February 16 they are preparing for the next phase of the COVID-19 pandemic as Omicron-related cases decline, including updating CDC guidance on mask-wearing and shoring up U.S. testing capacity.

CVS Health Corp. expects to administer 70% to 80% fewer COVID-19 vaccines in 2022 compared with 2021, adding that in-store diagnostic testing could fall 40% to 50%.

Peregrine Market Access, a leading life science commercialization partner, was selected by Nonagen Bioscience to become its contract commercialization organization for Oncuria. The breakthrough bladder cancer diagnostic test Oncuria is being developed to aid in detection, therapy choice, and disease monitoring. Under a multiyear, multimillion dollar agreement, Peregrine Market Access will lead the U.S. launch of Oncuria.

Abbott Laboratories will pay $160 million to resolve claims that two of the company’s units submitted false claims to Medicare by providing kickbacks to diabetes patients, including “free” or “no cost” glucose monitors, the U.S. Department of Justice said.

The U.S. Centers for Disease Control and Prevention (CDC) said on May 7 that U.S.-bound international air travelers can meet Covid-19 entry requirements using certain self-administered tests.

NASH

France-based Genfit launched NASHnext, a novel, non-invasive diagnostic test for nonalcoholic steatohepatitis (NASH) powered by the company’s proprietary diagnostic technology, NIS4. The test is offered in the United States through Labcorp.

FDA

The U.S. health regulator granted emergency use authorization for Abbott Laboratories’ molecular test to detect and distinguish the coronavirus and two types of flu viruses with a single test.

FDA

A molecular test from Becton Dickinson that detects viruses that cause Covid-19 as well as influenza and produces result in 2-3 hours was given emergency use authorization by the U.S. health regulator.