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.

Press Release:
Magellan Biosciences Subsidiary Receives CLIA Waiver from FDA for LeadCare II