CDC coronavirus test comes to labs | A closer look at payment policy | CRISPR drives diagnostics

Dear LabPulse Member,

The number of confirmed cases of the novel coronavirus -- 2019-nCoV -- has been mounting, with 40,554 infected people globally in 25 countries, including 40,235 in China, as of February 10, according to the World Health Organization.

With uncertainty about how the virus is transmitted and the ultimate toll it will take, the U.S. moved to declare a public health emergency and to bar entry to non-U.S. nationals coming from China. Soon afterward, on February 4, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) paving the way for use at qualified labs of a reverse transcription polymerase chain reaction (RT-PCR) diagnostic developed by the U.S. Centers for Disease Control and Prevention (CDC). The diagnostic panel is being distributed through the CDC's International Reagent Resource in Manassas, VA.

The U.S. Centers for Medicare and Medicaid Services (CMS) then provided guidance for labs on use of the test, stressing that providers must adhere to CLIA regulations and be qualified by the CDC. Qualified labs need to verify test performance specifications, and surveyors will be on the lookout for labs using a coronavirus assay without an EUA, CMS advised.

In separate news, published an editorial about CMS' first national coverage determination (NCD) on next-generation sequencing for somatic and germline mutations. Lisa Schlager, a patient advocate with the nonprofit organization Facing Our Risk of Cancer Empowered (FORCE), explored what the NCD really means for Medicare patients with hereditary breast or ovarian cancers in getting access to testing.

Payment policy appears to be more effective than practice recommendations when it comes to steering the utilization of lab tests, according to a study of health systems in the U.S. and Canada that was just published in JAMA Internal Medicine. Researchers evaluated the effects of Choosing Wisely recommendations and payment policy changes on the utilization of unnecessary vitamin D and thyroid function tests and found that reimbursement is an "underused lever."

Potential applications of clustered regularly interspaced short palindromic repeats (CRISPR) technology include genome editing to eliminate single-gene diseases. But CRISPR is also a platform for diagnostics. In an article we published yesterday, contributing writer Joseph Constance reported on some of the ongoing activity for applying CRISPR to the development of rapid, point-of-care diagnostics. One startup called Sherlock Biosciences, for example, is developing CRISPR diagnostics for infectious diseases; it expects to evaluate the technology in clinical trials in two years and to commercialize it in three years.

Page 1 of 1