Microbiology Insider

Dear Microbiology Insider,

The Microbiology Community of has been most active lately, which is understandable in light of the continuing public health emergency due to COVID-19.

The impact of the COVID-19 pandemic is being felt far and wide, with a silver lining for some. A recent report from market research firm Kalorama Information, a sister company of, showed that the molecular diagnostics market will exceed $13 billion in 2020, which is $5 billion higher than in 2019. The growth is largely being attributed to sales for COVID-19 tests. And if present disease trends continue, COVID-19 testing and related sales are slated to continue into 2021, the analysts noted.

Second-quarter earnings have illustrated the experience of leading manufacturers in the space. For example, in its July 23 report for the first half of 2020, Roche said that its sales had been hit by the pandemic, but that its molecular diagnostics division was up by 61%, helping to offset losses. The company noted that the outlook started to improve in June with the lift of some lockdowns.

And in our feature article for this Insider, Kalorama analyst Justin Saeks reported on how volumes of coronavirus testing have varied across the world, along with differences between when the virus arrived and whether mitigation and suppression efforts were successful.

This Insider includes links to stories exploring the effect of the novel coronavirus on labs from many different angles, including perspectives on clinical, business, and regulatory issues.

For clinical labs, the pandemic has meant a dramatic decrease in the volume of many non-COVID-19 tests, as shown by surveys conducted in April by Kalorama Information and the College of American Pathologists (CAP). Kalorama and CAP conducted follow-up surveys and both found an improved outlook, though testing levels were still well down from the days prior to the pandemic.

On the regulatory front, the U.S. Food and Drug Administration has been very active in issuing emergency use authorizations during the pandemic for diagnostics, testing methods such as sample pooling, and novel collection kits for specimens at the point of care. The agency has also been working to alert labs when things go wrong with products cleared quickly, such as the risk for false positives with Becton Dickinson SARS-CoV-2 reagents and the removal of faulty antibody tests from stock.

But it's not all about COVID-19! Coverage in other therapeutic areas included launches of tests for sexually transmitted diseases and cancer. In May, we reviewed results from a study evaluating Binx Health's newly approved point-of-care polymerase chain reaction (PCR) test for chlamydia and gonorrhea in women and men.

More recently, company researchers at Quest Diagnostics evaluated cotesting with human papillomavirus screening and the traditional Pap test versus either test alone for cervical cancer detection in a real-world study published in the American Journal of Clinical Pathology.

For the full picture on microbiology, be sure to visit our community.

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