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The laboratories most likely to survive the cuts to the clinical laboratory fee schedule are those that are operationally efficient, financially fit, and strategically diversified. As labs now see the 2018 rates reflected in their books, the real effects of the Protecting Access to Medicare Act that called for the…
Cardiac troponin testing has been adopted world wide as part of the workup for suspected myocardial infarction. In other parts of the globe high-sensitivity assays have been used for many years in clinical practice. Now, as these assays are beginning to enter the U.S. market, the Food and Drug Administration…

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Bench Matters

Federal Insider

In its haste to guarantee payment for one breakthrough test, CMS may have stumbled as the agency ventures into contentious territory around laboratory developed tests. This might spell trouble for labs using other methods, according to AACC and other laboratory organizations.
After throwing out a plan for bundled Medicare payments drawn up by the previous administration, the CMS is launching a new take on how to move from fee-for-service to value-based care. The new program emphasizes voluntary participation aimed at reducing paperwork and overhead for providers who are not yet ready.

Industry Playbook

Singapore-based Vela Diagnostics has signed a license agreement with the University of California, San Francisco for two technologies for enriching rare sequences in nucleic acid libraries known as Finding Low Abundance Sequences by Hybridization (FLASH) and Depletion of Abundant Sequences of Hybridization (DASH).

Mini Review

Rising opioid abuse during pregnancy has boosted the number of expectant mothers on opiate maintenance therapy and the incidence of neonatal abstinence syndrome. Neonatal toxicology testing is a unique area of laboratory stewardship that encompasses managing test utilization, educating stakeholders, interpreting results, and contributing to the development of institutional policies.

Regulatory Roundup

DxNA has received Food and Drug Administration clearance for the DxNA GeneSTAT.MDx Coccidioides test, making this the first FDA-authorized molecular test for the rapid detection of coccidioidomycosis, a fungal infection also known as valley fever.
Hologic’s CE-marked Aptima HIV-1 Quant Dx assay has been awarded the World Health Organization prequalification for in vitro diagnostics, which allows global health organizations to consider this test for public sector procurement in resource-limited countries.

The Sample

A study of 12 cardiac biomarkers in four cohorts comprising 22,756 participants found that different biomarkers predict incident heart failure with preserved ejection fraction versus heart failure with reduced ejection fraction. The findings highlight the need for future studies to better understand the role of biomarkers in estimating risk for…