Clinical Lab Business Picking Back Up, New Survey Says

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The American Clinical Laboratory Association has sued to block proposed 2018 Medicare payment rates for clinical tests calculated under the Protecting Access to Medicare Act (PAMA). [Source:  Clinical Center
[Source: Clinical Center]

Clinical laboratories are showing signs of rallying after the recent slump in activity due to COVID-19, according to a new study from Arlington, Va.-based Kalorama Information, an in vitro diagnostics market research firm.

The study, released June 25, found labs are running more tests and a greater variety of them since May, but they are still reporting “a major decline,” when compared to pre-COVID-19 times.

Kalorama’s survey of labs nationwide found that currently labs are reporting a decline of 54% in lab tests other than for COVID-19, including tests for cancer, autoimmune diseases, diabetes and allergies—up from 62% reported at the end of May and 82% reported on May 7.

“While still not optimal for the laboratory industry and IVD firms that sell products to them, the steep drop in clinical labs reporting major declines is promising,” Kalorama said.

A small number of labs are reporting no decline. The study found that 15% of labs were now reporting “no decline at all in non-COVID-19 test volumes”—up from 3% in May.

Kalorama researchers attributed the increased lab activity to hospitals in some states re-opening for elective surgeries and for care other than what is needed for COVID-19. Thirty states, including California, Texas, Ohio, Mississippi and Utah, have recently relaxed restrictions on elective surgeries, the firm said. “This means more cancer testing, more pre-op and post-op blood work is being performed, and patients may be tested for diabetes and other conditions,” Kalorama researchers said.

The study also found that in addition to increased lab activity, there has been a surge in the development of in vitro diagnostic device lab supplies and products as IVD vendors tackle the COVID-19 crisis. More than 100 lab tests of various types have received Emergency Use Authorization from the U.S. Food and Drug Administration, with hundreds more are being sold under the European Union CE mark.

Vendors continue to enlarge the number of tests in molecular and immunoassay tests, including several recent innovations, according to Kalorama. Among them: Illumina obtained an authorization for a COVID-19 test on its high-volume NovaSeq, and Roche received authorization for an IL-6 test designed to detect patients who are having a severe inflammatory response.

Kalorama Information covers clinical diagnostic markets, with its essential report on the IVD industry, “Worldwide Market for In Vitro Diagnostics,” considered to be “a leading market research tool.” On April 7, Kalorama also published a specific report on COVID-19 impact, titled, “Kalorama COVID-19 Update: Molecular Diagnostics, Immunoassays, Vaccines, Telehealth and Other Areas.

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