NEW YORK – Bolstered by substantial funding rounds and a US Food and Drug Administration clearance, diagnostic firms are progressing toward the goal of bringing routine clinical testing to the point of care.
Recent data releases and product demonstrations indicate that POC platforms can now approach or equal the performance of conventional clinical analyzers for many routine tests. Whether these technologies will meet success in the market, however, remains to be seen.
Point-of-care testing has become commonplace for a wide range of applications like glucose monitoring, pregnancy testing, and for various infectious diseases. Most routine clinical testing, however, is still done in central laboratories on large clinical analyzers.
In recent years, a handful of companies including the San Diego-based firms Truvian Health and Genalyte, Canadian firm Vital Biosciences, and Fremont, California-based Chronus Health, have worked to develop devices capable of performing many routine lab tests at the point of care, the notion being that moving such testing to settings like doctors' offices and urgent care centers could speed and streamline the delivery of results and, consequently, the delivery of care.
Industry observers have also suggested 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 more quickly return results to their customers and reduce sample shipping costs.
Recent months have seen notable activity in this space, as, in July, Chronus introduced its electrical sensing-based POC technology, Truvian closed a $74 million funding round, and Genalyte received FDA 510(k) clearance for a thyroid stimulating hormone (TSH) immunoassay on its POC Maverick testing platform. Additionally, Vital Bio presented data on its platform's performance and offered user demonstrations at the Association for Diagnostics and Laboratory Medicine (ADLM) annual meeting.
In an interview earlier this month with 360Dx, Truvian CEO Jay Srinivasan said the company plans to use its newly acquiring funds for clinical trials evaluating its clinical analyzer. Truvian aims to make a submission to the FDA in late 2024 or early 2025.
Srinivasan said the firm will launch its system with its Truvian Wellness Panel, which will feature routine tests including a complete blood count differential, lipid panel, chemistry panel, HbA1c, and TSH.
Genalyte, meanwhile, is working to build out its assay portfolio, having received 510(k) clearance for its TSH immunoassay. The TSH test runs on the company's Maverick platform, which uses a form of whispering gallery mode resonance for analyte detection.
Genalyte CEO Ashraf Hanna said the company is now working to generate data for FDA submissions of tests on the Maverick platform including HbA1c, vitamin D, HIV, hepatitis B and C, and CRP. He said it expects to make an additional FDA submission every two to three months with the goal of having FDA-cleared tests for 80 to 90 percent of routinely ordered immunoassays by early 2025.
Genalyte is taking a different strategy from its competitors in the POC routine testing space, as it plans to use its own Maverick platform for the immunoassay portion of its test menu but use third-party instruments for the hematology and clinical chemistry portions of its menu. The company will combine these three instruments in its Merlin product, a fully automated testing system about the size of a small refrigerator.
Hanna noted that compact, FDA-approved hematology and clinical chemistry analyzers have existed for years but said they have received relatively little uptake in the POC markets Genalyte is targeting due to the fact that they require hands-on operation and, on their own, cover only a limited portion of typical routine testing menus. Genalyte expects that by combining such analyzers with its Maverick device and automating upfront sample prep it will better meet the needs of POC settings.
Hanna declined to say whether the company has secured agreements with any third-party vendors to provide the hematology or clinical chemistry portions of its Merlin system. He said, though, that he has received encouraging feedback from at least one potential supplier who viewed inclusion in the Merlin device as a potentially new source of sales for its instruments and reagents.
Genalyte is currently running studies comparing the performance of the Merlin device to that of traditional analyzers and plans to submit that system to the FDA in the near future, Hanna said.
Vital Biosciences also continues to push its POC platform, the VitalOne, toward FDA approval. Stan Schofield, managing principal of lab trade federation The Compass Group and former president of the Maine-based regional laboratory system NorDx, put the company's analyzer through its paces at a demonstration during the recent ADLM annual meeting in Chicago.
During the demonstration, Vital representatives took a blood sample from Schofield and ran roughly 20 tests on the company's platform including a complete blood count, a chemistry panel, and several routine immunoassays. Schofield said the Vital results matched the results from lab work that he recently had done at a central lab.
The instrument took around 20 minutes to deliver the results and was operated by an individual without medical technologist training, similar to personnel who might operate a CLIA-waived testing system, Schofield said.
A spokesperson for Vital said that in most of the company's demos at ADLM it returned roughly 40 test results including a CBC with a five-part differential, most of a comprehensive metabolic panel, including electrolytes, a lipid panel, and immunoassays including TSH, fT4, D-Dimer, and CRP. The platform used roughly 500uL of whole blood dividing across a li-hep sample for clinical chemistries and immunoassays and an EDTA sample for hematology, the spokesperson added.
Vital declined to comment further on the development of its platform and its progress toward regulatory approval and commercial launch.
Chronus, likewise, highlighted its POC analyzer at the ADLM meeting. Unlike most clinical analyzers, which typically use optical-based detection methods, Chronus uses electrical-based detection, which CEO and Cofounder Anand Parikh said the company believes will allow it to offer more rapid, less expensive testing than its competitors. The system measures changes in electrical current to detect, for instance, the presence of different blood cells for a hematology assay or binding of an affinity agent to its target in an immunoassay.
Chronus is also breaking with traditional lab testing by using aptamers instead of antibodies for its immunoassays. Ashish Jagtiani, Chronus's cofounder and CTO, acknowledged that antibodies are a well validated, widely used technology but said the company sees significant advantages in moving to aptamers.
"They are very simple to produce, they are very reliable, and they are very low cost," he said. "DNA technology has come very far from where it was even five years ago."
Parikh said the company has run thousands of samples on its platform, comparing them to results generated on traditional analyzers. He said Chronus plans in the near future to close a Series B funding round raising "north of" $20 million after which it will launch clinical trials to support an FDA submission for the system. Chronus closed a $22 million Series A round in 2022.
As Genalyte's FDA clearance and Vital's ADLM demos suggest, routine testing at the point of care is approaching technical feasibility.
Vital, Truvian, Genalyte, and Chronus "are making material progress… and the quality of tests is pretty good," said Donna Hochberg, a partner with Newton, Massachusetts-based healthcare consulting firm Health Advances.
The next step is demonstrating commercial viability. This, Schofield suggested, will largely come down to price, turnaround time, and throughput.
Price, in particular, will be important in determining how large a market routine POC systems reach, Schofield said, noting that the declining reimbursement rates for much routine testing could prove a challenge, particularly when it comes to penetrating physician offices, a target of several routine POC testing firms. Payments for testing in physician offices has come under pressure in recent years from both private and government payors, Schofield noted, adding that in general POC testing is more expensive than central lab testing.
Hochberg said that this could be a particular challenge for companies like Truvian and Vital Bio whose systems are designed to run large panels even in cases where a doctor wants only a subset of the offered tests.
"For the full panel you would imagine that the reimbursement is sufficient to cover the cost," she said. "It's when you start to get down to smaller pieces of the panel, what do the economics look like? For some of these tests included on these panels, reimbursement is really low. A metabolic panel or a CBC, the reimbursement rates for those are pretty low, and so, in order for this to work you are going to have to have a per test [cost of goods] that is in that range."
None of the mentioned companies have released pricing for their platforms or their tests, but during a presentation at the 2023 ADLM Disruptive Technology Award Competition, Mounir Koussa, Vital Bio's cofounder and VP of R&D, said that the system is cost-competitive with send-out tests even when only reporting a metabolic panel and a CBC.
Chronus's Parikh, meanwhile, said his company's system will be "extremely low cost," with per test costs "much below the reimbursement," though he declined to provide specific figures.
Truvian has said that, when produced at scale, its test panels can be manufactured for under $10, though it has not said what price it will charge users for the panels.
Turnaround time will also be key, with Hochberg suggesting that platforms will ideally return results in less than 30 minutes. Truvian said it can return results in under 30 minutes, Vital said it can deliver results in 20 minutes, and Chronus said it has turnaround time of 15 minutes. Genalyte's recently cleared TSH assay delivers results in around 30 minutes.
Schofield also raised throughput as a potential concern, noting that a rate of one sample every 20 to 30 minutes may not be sufficient for some settings like larger physician practices that might want to run 10 or more patient samples in an hour. Chronus' modular platform design may prove an advantage in this regard as users can mix different numbers of CBC, chemistry, and immunoassay modules depending on their needs.
Hochberg questioned more generally whether physician offices were a favorable setting for these businesses, at least at the outset, given the challenges involved from a sales and distribution perspective.
"The primary care call point is just enormous and very hard to manage, to try and drive test volume and sell things," she said, suggesting that settings like surgery centers, urgent care centers, and infusion centers might be better initial targets.
"They are a little more niche but easier to manage from a sales and distribution perspective," she said.
While routine testing POC firms have in the past identified physician offices as a key target, recent comments from some indicate they may be thinking along the lines Hochberg suggested.
Genalyte's Hanna said that while the company is still evaluating what settings it will target first, it sees surgical centers as a particularly interesting opportunity.
For such centers a major concern is patients showing up for surgery without having the required lab results, he said. "And for the sake of $50 worth of labs, your surgical suite sits idle for three hours."
Chronus is looking at settings like skilled nursing facilities, urgent care, and infusion centers as initial targets for its platform, said Parikh. He said the company plans to launch into these markets with its CBC and metabolic panel modules and then potentially expand into areas like primary care as it builds out its test menu.
"You have markets right now that need this… that all they need is a CBC and a CMP and they can make the [clinical] decision right there," he said.
One challenge companies may confront in entering these spaces is a lack of personnel trained to oversee moderate complexity CLIA testing, meaning their platforms may need to be CLIA-waived. 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.
Chronus, Vital, and Truvian have all said they ultimately aim to receive CLIA waivers for their systems. Genalyte, meanwhile, plans to offer a model in which the company provides oversight for facilities not equipped to run moderate complexity testing and serves as the lab of record, taking responsibility for accuracy and release of results and for billing insurance for the tests.