Medical Device Daily Contributing Writer
A Canadian company has received FDA approval for a one-minute rapid HIV antibody test, marking the first time in five years such a test has been approved for point-of care use in the U.S. FDA approval of the INSTI test, says bioLytical Laboratories' (Richmond, British Columbia) chief technical officer Rick Galli, is almost as significant as the speed of test itself. Only eight Canadian companies have ever received FDA approval for a medical diagnostic device, he said.
“A PMA process is the most rigorous regulatory procedure you can go through,“ Galli told Medical Device Daily.“ A lot of medical devices do not make it through that process. It's something to be proud of to pass that level of scrutiny.“
Rapid HIV antibody testing represented a quantum leap over conventional lab testing about a decade ago when it began paring down the turnaround time for test results from as long as two weeks to 20 minutes. In August that bar dropped even lower when a clinic in London boasted a test that takes a mere five minutes to complete – and proved it by timing the test against a Ferrari speeding through the streets of Soho.
Rick Galli has stopped short of pitting his one minute test against a Formula One racing car. That's because the test has already been shown to be effective in Canada and more than 50 other nations. U.S. approval represents a major marketing breakthrough for the company.
“It allows us to enter the U.S. which is a rapidly growing market for this type of device and one in which we have invested a lot of time and energy . . . There has been a lot of interest in the one minute test concept. People in the U.S. have never had that choice before.“
Someone whose patients have had that choice is Jane Greer, a nurse and administrator at Canada's largest anonymous HIV test center, the Hassle Free Clinic (Toronto). Greer said the test is part of a comprehensive pre- and post-counseling session patients at her clinic must undergo if they are to be tested. Staff, she added, couldn't be more delighted.
“It's fantastic,“ Greer told Medical Device Daily. “It's improved our patient care in so many ways. It reduces client anxiety like crazy and because of this, actually encourages testing.“
Greer stressed that the INSTI test is not a confirmed result, but “is so sensitive and specific“ that it provides clinical staff and patients with an extraordinarily high level of comfort. This should make the test particularly attractive to those U.S. jurisdictions where the rates of patients returning for HIV testing, she said, is “abysmally“ high.
Rick Galli agreed. His test removes the worry patients experience waiting for the longer test and encourages more people who may be HIV positive to be tested. Even waiting for twenty minutes, he said, creates “a level of anxiety that is hard to take for some patients.“
“What we're hearing from the provider perspective, especially in emergency room settings where you really don't have twenty minutes to administer a test and wait for a result is that the one-minute test is really valuable.“
bioLytical's faster results are achieved by utilizing flow-through instead of lateral-flow technology, Galli said. The test has been approved for detecting antibodies to HIV-1 in whole blood, finger stick blood, or plasma specimens, with clinical trial data demonstrating a minimum sensitivity and specificity for those methods of between 99.5% and 99.8%. The INSTI test includes a unique antigen construct comprised of recombinant proteins for HIV-1 (gp-41) and HIV-2 (gp-36).
These unique antigens, Galli said, are particularly important as the HIV testing community heads toward a multi-rapid test algorithm, eliminating the need for the more costly and time-consuming Western Blot and Indirect Fluorescent Antibody tests. He added they also provide bioLytical an advantage in a marketplace that sees “tens of millions of HIV tests conducted annually in the U.S.“
Someone else who has thrown his weight behind the one-minute test is Robert Gallo, MD, co-discoverer of the Human Immunodeficiency Virus and currently director of the Institute of Human Virology (IHV) at the University of Maryland School of Medicine (Baltimore). “The Institute for Human Virology would be willing to collaborate with bioLytical to explore the use of the product in novel settings worldwide and in the USA by providing both the population and expertise necessary,“ Gallo said. “A rapid, accurate, sufficiently sensitive and inexpensive field testing kit for HIV has been needed for a long time.“
Getting both FDA approval and Gallo's public endorsement is a major accomplishment for his firm, Galli said. That's because organizations like IHV do a lot of work in a variety of settings, including very difficult to reach populations. “It's always good to have groups like that work with the test and be able to comment on its performance. It's difficult for a company like bioLytical to do that work itself.“
Even with Gallo's endorsement and FDA approval, some U.S. patients will have to wait a while longer before they can take the one-minute test. That's because some labs and end users in the U.S. have a waiver certification exempting them from Congress's Clinical Laboratory Improvement Amendments (CLIA) legislation which establishes quality standards for all laboratory testing. bioLytical must wait for the results of its waiver designation application before those users can employ the INSTI test. Typically, a waiver designation is only granted if it is simple enough to render the likelihood of erroneous results negligible.
A waiver designation, said Galli “means we could market the test to any level of facility including those that have a certificate of waiver of CLIA. Right now we are restricted to people who are certified to do moderately complex procedures.“
Assuming it passes this last hurdle, Galli said the INSTI test would be the most cost-effective rapid test on the market. At a cost of $8 to $12 U.S. per kit, the company's 30,000 square foot robotics-based facility is capable of producing 80 kits a minute or 1.5 million kits a month.