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.
On September 18, Magellan Biosciences announced that the FDA had granted a CLIA waiver for its new LeadCare® II blood-lead testing system, developed and marketed by the company’s subsidiary, ESA Biosciences. This device is now cleared to be used in non-laboratory settings, such as schools and mobile lead testing vans. The device is a key element of Magellan’s strategy to expand its offerings into the global point-of-care clinical-diagnostic market.
Any CLIA waver for a test is significant because it implies that the diagnostic technology will allow any operator to perform the test without special training or advanced certification – and get accurate, reliable, and reproducible results. Magellan’s President and CEO, Robert J. Rosenthal, says that Magellan’s plans are to use the LeadCare II platform to develop additional point-of-care tests.
DARK Daily suggests that existing laboratories take note of this news item for a number of important reasons. First, it is becoming cheaper, simpler, and faster to perform the latest generations of diagnostic tests. In the case of LeadCare II, the instrument costs $2,200 and each test kit costs $7. It uses a capillary or venous blood sample and EDTA or heparin is the anticoagulant. Two drops of blood, about 50 µl, are mixed with the reagent, transferred to a sensor strip, and a reliable answer is produced in three minutes. This allows the patient to wait in case a second sample is needed for further testing.
Second, the CLIA waiver granted for LeadCare II shows how biotech companies are investing heavily to create new technology and instrument systems that can be used outside a core laboratory to perform testing at patient’s bedside or in the physician’s office.
Third, the potential market for the LeadCare II test is large. Estimates are that one out of four children under six live in a home that has significant lead contamination. Detecting children with lead poisoning is the type of public health issue that attracts wide support and ample funding. Those are key reasons why ESA Biosciences developed this particular test.
DARK Daily predicts that much of the new diagnostic technology soon to hit the market will make it simple and reliable to perform certain diagnostic tests outside the core laboratory. In the case of the LeadCare II system, the instrument is affordable, the test kit relatively cheap, a finger stick specimen is all that is needed, and the results are provided in just three minutes. 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 play the “If I can’t beat ’em, I’ll join ’em” game and develop mobile units to administer point-of-care tests.
Magellan Biosciences Subsidiary Receives CLIA Waiver from FDA for LeadCare II