Call for more vitamin D testing | What's in FDA's private safety database? | Putting lab guidelines to the test

Dear Lab Pulse Member,

Vitamin D testing was back in the news this week. Researchers affiliated with the Children's Health Study, which is supported by the U.S. National Institutes of Health, linked low levels of vitamin D as measured on a liquid chromatography-tandem mass spectrometry assay in newborns with the development of elevated blood pressure in childhood.

Their recommendation? Screening and vitamin supplementation for pregnant women and babies at higher risk for developing cardiovascular problems, they reported July 1 in the journal Hypertension.

The latest news follows an analysis we covered last month that found vitamin D does not help prevent cardiovascular problems, with the authors suggesting the nutrient is not the panacea to many health problems it is portrayed to be. Debates about the value of testing and supplementation are sure to carry on.

In other news, the U.S. Food and Drug Administration ended its Alternative Summary Reporting (ASR) program, a private database for logging problems with devices that was maintained apart from a publicly accessible forum. In the process, the agency published ASR data it had collected for about 20 years, noting that the data are unverified. Word soon spread of millions of reports of problems with glucose meters in the agency's "hidden" database. However, as market research firm Kalorama Information pointed out, there are as many as 20 billion patient interactions every year with glucose meters in the U.S.'s contributing writer Joseph Constance weighs in on different ways of evaluating whether practice guidelines are being adopted in clinical laboratories. The study of the adoption of guidelines from the College of American Pathologists (CAP) highlights the downsides of checking with staffers by phone. Separately, CAP opened a public comment period on a new guideline for whole slide imaging, with feedback open through July 19.

Recent product news includes an announcement by new artificial intelligence-driven diagnostics company RenalytixAI that its KidneyIntelX test for predicting rapid decline in kidney function has been assigned a current procedural terminology (CPT) code for use in U.S. reimbursement, effective in October. The company is developing products aimed at predicting -- and hopefully preventing -- common, costly conditions. A Medicare payment rate for the new code will likely kick in next year, the company said.

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