It comes down to a prick to the finger and counting to 60.
After giving a small blood sample, a patient can find out with nearly 100% accuracy whether he or she is HIV-positive.
The INSTI test, which was developed at Richmond-based bioLytical Laboratories and approved by Health Canada in 2006, has been building momentum in the United States since being allowed to be used in non-lab settings, thanks to something called the Clinical Laboratory Improvement Amendments (CLIA) waiver.
The CLIA waiver has been instrumental in the company’s rapid growth abroad, bioLytical’s executive director Christopher Shackleton told Business in Vancouver.
“You really can’t use a point-of-care (POC) product like this without having that designation for your kit in the U.S. The types of groups that are doing this type of testing are all CLIA-waived facilities,” Shackleton said. “We’re really only now touching the surface of many of these markets.”
Worldwide sales of INSTI test reached $3.92 million in the third quarter of 2013, and it was the first quarter that U.S. sales topped $1 million. That’s more than double the $1.83 million in sales bioLytical made in the same quarter a year earlier.
The near-instant results stand in contrast to all other CLIA-waived competitors, which take 15 to 30 minutes for results.
Because the 60-second INSTI test provides faster turnaround, more tests can be administered in a single day. This means that clinics, hospitals and correctional facilities go through more of them in a shorter period and maintain more frequent purchase orders.
INSTI tests were even used to break the Guinness World Record in 2012 for HIV testing in one day. Tests were administered to 745 people over eight hours at a single site in London.
Julio Montaner, director of the B.C. Centre for Excellence in HIV-AIDS, said POC testing that provides near-instant results has been a great asset to the province’s own efforts to eliminate HIV.
“It gives an opportunity to bring the tests to people that would otherwise not come to me for the test. I can do it in [greater] numbers very effectively, very rapidly and so in one minute you can actually know your answer,” he said.
“We need every single tool in the toolbox if we’re going to defeat this epidemic,” Montaner added.
