NEW YORK – Some five years after the collapse of Theranos, a handful of diagnostic companies are once again trying to bring routine clinical testing to the point of care.
And while these firms appear to have more solid scientific footing for their technology than the now-infamous testing startup, they still face substantial technological, regulatory, and business challenges as they try to push their systems to market.
Point-of-care (POC) testing has become a mainstay of medical practice, but the bulk of routine testing is still done in central laboratories.
Companies developing devices for POC routine testing believe that moving it into spaces like doctors' offices or urgent care centers could streamline medical practice by allowing clinicians to order and receive lab results during a patient visit, reducing the need for follow-up and accelerating time to treatment.
Some industry observers also suggest that companies like Laboratory Corporation of America and Quest Diagnostics, whose businesses are built on the central laboratory model, might take an interest in these new technologies as they could speed return of results to their customers and reduce sample shipping costs.
No company has managed to bring a platform for routine POC testing to market yet, but there have been a number of significant developments in the space in recent months.
At the American Association for Clinical Chemistry (now the Association for Diagnostics & Laboratory Medicine) annual meeting in July, Canadian diagnostics firm Vital Biosciences, which is developing a clinical analyzer called the VitalOne for use in settings like doctors' offices and urgent care, was one of three finalists at the meeting's Disruptive Technology Award Competition. While the company, which has to date raised $48 million from investors including Northpond Ventures, Labcorp, and Inovia Capital, didn't win the competition, it was the audience favorite, taking 37 percent of the audience vote, compared to 35 percent for mass spectrometry firm MS Pen and 28 percent for microbiology outfit Pattern Bioscience.
Also at AACC, San Diego-based Truvian, which is likewise developing a point-of-care clinical analyzer, presented data from a reproducibility study and a multisite, 237-sample study comparing the results of its platform to results generated on central laboratory analyzers.
Another San Diego-based firm, Genalyte, is also working to push a POC routine testing platform to market. In April, the company closed a $67 million Series C financing round led by Verily Life Sciences and Boutique Venture Partners. The company's platform, called the Merlin Automated Lab, is based on its Maverick analyzer, which uses a form of whispering gallery mode resonance for analyte detection.
According to Donna Hochberg, a partner with Newton, Massachusetts-based healthcare consulting firm Health Advances, these three firms are the primary players in the POC routine testing space, with Genalyte likely the closest to a commercial launch. She said she believes that several other companies are also looking to tackle this market but haven't yet made their plans public.
Hochberg said there are clear advantages to bringing routine testing into the doctor's office. In the case of well visits, in-office testing would be more convenient for patients and would allow doctors to discuss test results with patients during their visit as opposed to having to follow up with them after receiving the results of send-out tests. In the case of sick visits, such testing could provide information not currently available at POC that could help in making a diagnosis.
"Physicians would definitely benefit," Hochberg said. She noted, however, that particularly in the case of sick visits, rapid turnaround time will be essential.
"Wellness exams tend to be a little longer than sick visits, so there you have a little wiggle room with turnaround time," she said. "But for this to work for sick visits where you are trying to figure out what is going on, it has to fit into that visit window, which on the long side is like 15 minutes."
At the moment, that 15-minute time frame doesn't appear to be within reach. Truvian CEO Jay Srinivasan said his company's platform currently delivers results in under 45 minutes and that it ultimately aims to reduce that between 30 and 40 minutes. Genalyte CEO Ashraf Hanna said that turnaround times for tests on his company's platform currently range from six to 22 minutes and that it is targeting 30 minutes as its goal. During Vital's presentation at AACC, Mounir Koussa, the company's cofounder and VP of R&D, said its platform's turnaround time is 20 minutes.
Hanna said Genalyte expects patients and physicians will be willing to extend their visits a bit longer if they can get lab results during it. He said that, according to the company's data, on average, 18.5 minutes elapse between the time a patient checks in for a visit and the time the doctor sees them.
"We're thinking that if we increase that by just 10 minutes, people will give us that 10 minutes to get all their lab tests," he said.
Hochberg said that she could envision such platforms finding a place in various other settings even without the turnaround time she expects will be needed to drive uptake in physician offices. She cited as examples oncology practices that need to do patient wellness checks prior to giving infusions as well as stat labs in small hospitals or larger physician practices that maintain their own in-house labs.
Srinivasan said Truvian is looking at a number of potential settings for its system, including doctors' offices, clinics like Carbon Health and One Medical, long-term care facilities, and dialysis centers.
"Our targets are anywhere … turnaround times of one to two days [are] impacting the quality of patient intervention," he said.
Stan Schofield, managing principal of lab trade federation The Compass Group and former president of the Maine-based regional laboratory system NorDx, said that the market for these systems will depend in large part on what degree of complexity the US Food and Drug Administration assigns to them. To offer CLIA-waived tests, a site must have a CLIA certification but does not need to undergo inspections or have a laboratory director overseeing it. Moderate-complexity testing requirements are more stringent and include inspections and oversight by a lab director.
While Vital has said it aims to make its platform CLIA-waived and, ultimately, available even to home users, Schofield said that waived versions of POC routine testing platforms are likely years off and that moderate-complexity platforms are more realistic in the near term, which could limit the reach of these systems.
Genalyte's Hanna agreed that CLIA-waived platforms are a heavy lift, at least in the short term.
"A lot of the tests you do regularly are not waived, and I think it would be a pretty big effort to get them to be waived," he said.
To get around this limitation, Genalyte has developed a workflow in which testing done on its Merlin systems will be overseen by a lab director.
"We are making our machine simple enough that anyone can operate it," he said. "All you do is drop in the [sample] tube and it will know what tests to run and it will run them."
The test data will then go to a laboratory director who will review it in compliance with CLIA guidelines, Hanna said. In Genalyte's ongoing beta testing, lab directors are reviewing the test data on-site. Ultimately, though, lab directors will review the test data remotely, he said.
"The lab results will come [off the machine], and they will go to the certified lab scientist [CLS], and our vision, what we have talked about with FDA, is that that CLS can be located anywhere," Hanna said. "And they can say, 'Yes, the machine was operating at the right temperature. I got the right quantity of blood, the right quantity of reagents. There were no errors. The machine was running correctly.' And based on that, they can say it is a valid result and they will send it out to the EMR where the doctor sees it."
Hanna said Genalyte has two models for this service: one in which the company provides this oversight and serves as the lab of record, taking responsibility for accuracy and release of results and for billing insurance for the tests; and a second model in which customers who already have their own lab infrastructure can purchase the Merlin system and then they serve as the lab of record.
Schofield said POC instruments could potentially find a market as secondary systems for some labs.
"You have big medical practices where there are a couple hundred doctors in a building and they have a real lab with real equipment," he said. "Could one of these devices be a backup system? Possibly."
Large national labs might also be interested in these platforms, Hochberg said, suggesting that they could potentially place them at draw stations, enabling them to deliver patient results much more quickly than is currently possible.
She noted that this would fit well with these companies' increasing focus on customer convenience and experience.
"An avenue for growth that these big labs are using is that sort of direct-to-patient engagement approach, and getting your results really quickly — patients love that kind of thing," she said. "All of the tests on these panels are the top priorities on their at-home collection [menus]."
Labcorp is an investor in Vital Biosciences. It did not respond to inquiries about its interest in the company.
Hanna said Genalyte has spoken to Labcorp and Quest about their potential interest in systems like Merlin. He said he believes the ability to reduce those companies' shipping and logistics costs could prove attractive.
"If you look at their annual report, logistics is one of their largest expenses," he said. "There are pilots, co-pilots, hangars, landing fees, drivers, all of that to move blood samples from where they are drawn to their lab. And you could really diminish that."
He added that while some samples would still need to go to central labs for testing, POC systems placed in draw centers could handle much of the lower-priced routine testing.
The tests shipped and done centrally "will be the more expensive tests, the tests that are $100 or $200 or $500," he said. "The $7, $8 test, you could potentially do on-site."
Robert Boorstein, medical director of Brooklyn-based Lenco Diagnostic Laboratory, said that while these emerging testing technologies "are pretty impressive," he remains skeptical that they will see significant uptake.
He said he sees a number of barriers to adoption.
"Point-of-care testing is valuable when it can be used to make significant immediate binary decisions," he said. "Most of the tests on these menus do not have such clear utility."
He also noted that while the vendors in question have said they can perform around 85 percent to 95 percent of routine lab tests, the more important question is what percentage of patients will still need additional tests sent out. Doctors are less likely to invest in these platforms if they still need to send out testing for most patients anyway.
Hanna acknowledged this point and said that Genalyte projects its full panel will cover the total testing needs of 80 percent to 85 percent of patients. Boorstein said, however, that based on his lab's experience, he would expect 80 percent to 90 percent of patients to need testing beyond that provided by the POC instruments. He noted, for instance, that over half of his lab's patients with blood draws also have urine testing done.
Operating, as they are, in the shadow of Theranos, perhaps the most pressing question facing these POC firms is: Does their technology actually work?
In its AACC poster, Truvian presented data from a reproducibility study in which researchers tested 25 assays, running each 60 times using low, normal, and high controls for a total of 180 runs per assay across five days on three instruments at a single site. The company found that 74 of the 75 controls met required reproducibility thresholds.
Truvian also presented data on the correlation between 32 assays run on its platform and the same assays run on a central lab analyzer, finding largely good correlation across 237 samples.
Srinivasan said the company has begun several additional studies assessing the performance of its instrument and assays and how they compare to the equivalent central lab assays. He said it plans to make a 510(k) submission to the FDA but declined to provide a timeline for when that might happen.
Vital is working with Labcorp to test the performance of its VitalOne assays against central lab analyzers and, according to Koussa, has now done so with thousands of samples. The company has posted white papers detailing the performances of many of its assays on its website.
Hanna said Genalyte is in the middle of trials to support an FDA submission for the Merlin instrument and aims to make a submission by the end of this year in hopes of receiving approval in 2024. He added that once the company is satisfied it has collected enough data demonstrating the concordance between its system and central lab analyzers, it may begin offering assays on it as laboratory-developed tests.