On Wednesday, October 18, Abaxis, Inc., a manufacturer of portable blood analysis systems, revealed that the FDA granted waived status under CLIA regulations for six additional analytes, when those analytes are used in conjuction with the Piccolo point-of-care analyzer for the medical market. The analytes include: Amylase, Gamma Glutamyltransferase, Total Bilirubin, and Total Protein. The company noted that including the six analytes, it now has a total of 12 analytes that have received the CLIA waived status.
The CLIA waiver granted to Abaxis allows the company to offer the Liver Panel Plus test, along with the Lipids Panel and Lipids Plus Panel tests as waived tests to the medical market. This waiver comes on the heels of the waiver that DARK Daily reported was issued to ESA Biosciences, a subsidiary of Magellan Biosciences, for the LeadCare® II blood-lead testing system.
DARK Daily surmised that the LeadCare® II CLIA waiver was issued in part because lead poisoning is such a “hot topic” in the medical community and in the media. It is noteworthy that tests that monitor lipids and liver function have now received a similar waiver. These tests, although every bit as useful and vital to patients, are not the result of a “hot topic” medical condition. This suggests that the medical community may see CLIA waivers for additional diagnostic tests more quickly than previously thought.
Laboratories will likely feel the impact of simple and reliable diagnostic tests moving outside the core laboratory setting in the near future. Outpatient testing will be more convenient for patients and doctors alike, providing immediate answers to health questions. As more testing can be done in near-patient settings, the test mix in core laboratories is likely to shift away from routine testing and toward more complex reference and esoteric testing. Laboratories will have to adjust their focus so that these tests are viewed as their primary source of revenue. As point of care tests become more popular, laboratories may also want to develop mobile units to administer point-of-care tests.