The idea of a molecular diagnostic test winning a waiver under CLIA regulations was far-fetched at one time. But Idaho Technology, a DNA analysis firm in Salt Lake City, believes it’s an idea whose time has come.
The company, which has a long track record licensing its innovations to the military and companies like Roche, last year received a National Institutes of Health grant for $3.6 million and a $3.3 million grant from the U.S. Department of Defense to develop its FilmArray system and pursue a CLIA waiver for it.
Wade Stevenson is product manager for the FilmArray, a 10-inch by 15.5-inch instrument with technology that integrates the entire PCR process of sample preparation, amplification, detection, and analysis. “The major difference between FilmArray technology and the others out there for RVPs is user-friendliness,” he says.
“You put in a raw patient sample, hit ‘Go,’ and an hour later you have results for 21 different viruses and bacteria. Two to five minutes of hands-on time and you’re done.” Based on his demos of the instrument, he estimates labs will be able to train technologists to run it in 10 minutes.
That would suit the Defense Threat Agency, which made the award to Idaho Technology on behalf of the U.S. Air Force Assistant Surgeon General Modernization Directorate. The Pentagon is concerned about infectious disease in garrison and deployed troops and wants a test that novice laboratory personnel can perform that would provide the military with a near real-time force protection.
FilmArray is “as close as you can get to being able to do molecular testing without knowing anything about molecular testing,” says Dr. Richard L. Hodinka of Children’s Hospital of Philadelphia. “You add specimen into one port at one side of a small pouch-like device, add diluent to the other side to rehydrate the reagents, flip it in to the instrument, and away you go.”
“It’s a very exciting platform,” says Dr. Gregory Storch of Washington University School of Medicine, who is on Idaho Technology’s advisory board. “They’ve utilized very sophisticated microfluidics tests that can be carried out in an automated fashion with rapid extraction of the sample, amplification, and detection.”
The drawback is throughput, because, unlike the Luminex, FilmArray can process only one sample at a time. “Larger labs would have to buy several to meet their throughput needs, and that’s one reason why it will be more attractive to smaller labs,” Stevenson says. For one instrument the list price now is $49,500, but Idaho Technology plans to offer an aggressive multi-instrument discount.
It’s possible that labs could use FilmArray for clinical testing without FDA approval. “The only option would be an RUO—research use only—but for clinical testing, labs would have to do really extensive and onerous in-house validation, and you can’t get reimbursed for RUOs. So we’re not going to see significant traction in the market until it’s FDA-approved,” Stevenson says.
There is a sticking point, of course. “In order to be CLIA-waived you have to show your test has a low probability of false-positives in the intended-use setting,” he says. The process cannot require precise pipetting, for example. “But there’s a high degree of variability in training and in expertise in people who run CLIA-waived tests. It’s uncharted territory that’s been referred to quite accurately as the Wild Wild West.”
The company is hoping for an FDA nod allowing it to get the product to market before the next flu season starts in late October. “This summer I am setting up a number of ‘early access’ partners, labs who may want to ‘kick the tires’ and evaluate the instrument before launch.”
The H1N1 pandemic may have cast molecular testing in a new light, Stevenson points out. “There might be at most 200 to 300 labs in the U.S. right now using any molecular technique for respiratory pathogens. But the pandemic opened a lot of doors in the marketplace, because it really shed light on the lack of sensitivity that the rapid tests have, and it helped a lot of labs realize there could be a better solution.”