NEW YORK – As point-of-care test makers face new challenges following the boom times early in the COVID-19 pandemic, companies used the annual Association for Diagnostics and Laboratory Medicine in Chicago last week to showcase new capabilities of their technologies.
While POC technologies have not quite taken off in the way some anticipated it would in the wake of the pandemic, firms operating in the space said at the conference that the market remains a crucial opportunity and the focus remains bringing testing closer to patients and shortening turnaround times.
Nate Patton, VP of near-patient-care marketing for Roche, said that the company is seeing rising use of the PCR-based Cobas Liat platform in primary care, urgent care, and emergency facilities where the 20-minute turnaround times are used to provide answers within a patient's visit and start them on treatment right away. Expanding point-of-care testing at those sites helps to reduce hospitalization, expand access to testing, and reduce healthcare costs, he said.
The Liat's point-of-care menu encompasses tests for COVID-19, strep A, and the detection and differentiation of COVID-19, flu A/B, and respiratory syncytial virus. The firm also offers a Clostridioides difficile test for use on the Liat that can be performed in labs that have CLIA certification for moderate complexity testing.
Patton said that the firm plans to launch by early 2025 a Cobas Liat point-of-care multiplex panel for sexually transmitted diseases.
Meanwhile, Sharon Bracken, head of diagnostics for Siemens Healthineers, said that healthcare providers in North America and other developed markets have been turning to the firm's point-of-care technologies to help address bottlenecks in emergency and critical care through shorter times to results and improved ease of use. In developing markets globally, however, government healthcare authorities are more often seeking tools to expand access to testing in remote areas. Siemens' POC offerings include its portfolio of analyzers for blood gas, diabetes, and urinalysis testing.
At BioMérieux's press conference, Spencer Hunt, a product manager for the firm's molecular respiratory testing business, said that the firm has leveraged its laboratory-grade PCR technologies to deliver timely and actionable information in emergency rooms and physician offices through its SpotFire analyzer. The company launched last year the sample-to-answer instrument for multiplex PCR testing at the point of care and since has received FDA clearance and CLIA waiver for four syndromic panels, with the most recent regulatory green light given this summer for the BioFire Spotfire Respiratory/Sore Throat Panel Mini test.
Hunt said that the firm is focused on delivering its SpotFire syndromic respiratory testing products through the outpatient market including physician offices and urgent care facilities. He added that the analyzer helps to deliver results on upper respiratory tract infections within an actionable time frame, offers a simplified testing process, and helps to reduce the unnecessary or inappropriate prescribing of antimicrobials.
While the big, multinational firms may garner most of the attention, midsized and smaller firms also dot the POC landscape, and at ADLM, they vied for attention and stressed the importance of the ability to do rapid, accurate testing in point-of-care settings.
Co-Diagnostics CEO Dwight Egan said that it is inevitable that more of the infectious disease testing that is currently conducted in labs will migrate to decentralized sites such as pharmacies, physician offices, dental offices, community clinics, schools, and skilled nursing facilities. His firm hopes to meet that demand as well as use its point-of-care instruments to bring molecular testing to communities in India that currently rely on older, more time-consuming testing technologies.
"The whole world changes when you have a $300 real-time PCR multiplex box," he said.
Co-Dx recently submitted its Co-Dx PCR Pro instrument and COVID-19 test for FDA 510(k) clearance for over-the-counter use and said it plans to subsequently pursue POC clearance. Egan said that Co-Dx also is developing a multiplex test for COVID-19, flu A/B, and RSV as well as tests for tuberculosis, human papillomavirus, and group A strep. Though the firm had its instruments on hand for the Chicago meeting, Egan noted that it is developing an updated molecular testing instrument with expanded multiplexing from about five targets to upward of a dozen.
Amaru Araya-Williams, director of mechanical engineering for UK-based startup Lex Diagnostics, said that in the fall his company is starting clinical studies of the firm's ultra-fast PCR platform and respiratory panel tests in support of a dual submission for US Food and Drug Administration 510(k) clearance and CLIA waiver. The firm has found that its combination test for flu A/B and SARS-CoV-2 can deliver positive results within five minutes and negatives within 10 minutes. The company is subsequently developing a strep test.
"It's been an interesting couple of years in the point-of-care space," he said. "The market is consolidating at the moment, but that's, I think, actually really good for us."
That's because the company is poised to offer at low cost a test that would deliver results within the time of a typical patient-doctor visit. The company is leaning toward adopting a model in which the instrument would be offered at no cost to a user who would be charged only for the cartridge-based tests, he said, though he declined to be more specific.
According to Araya-Williams, "the market's screaming for it."
Dan Yeager, senior sales consultant for Werfen, meantime, talked up the firm's new Gem Premier 7000 platform with iQM 3 blood gas testing. The system adds the capability of hemolysis detection at the point of care, which he said could be used to address the top source of preanalytical error.
The FDA 510(k)-cleared instrument uses acoustofluidics for plasma separation and photometric determination to identify the amount of hemolysis in the sample and help healthcare providers to determine whether they need to draw a new blood sample. Yeager noted that hemolysis results in elevated potassium concentrations, which can lead to inappropriate patient management.
Yeager said that eight early adopters have been using the instruments in their hospitals, and they are seeing that hemolysis was more common than expected. Werfen also said in a statement that previously published studies suggest that hemolysis occurs in upward of half of whole-blood samples that are collected in neonatal intensive care units and 20 percent that are collected in emergency departments. Offering detection at the point of care will help clinicians make safe and rapid care decisions, according to Werfen.
At Polymedco, Todd Kelley, VP of medical affairs, said that his firm's point-of-care test for high-sensitivity troponin allows clinicians to quickly identify which patients with chest pain are having a heart attack, with results in 17 minutes. In emergency departments, those patients account for only 5 percent to 10 percent of those who present with chest pain, he said.
The firm secured FDA 510(k) clearance this spring for its PathFast hs-cTnI-II point-of-care assay for high-sensitivity troponin to aid the rapid diagnosis of myocardial infarction, and Kelley noted that the assay is the first high-sensitivity troponin test that has been cleared by the FDA for use at the point-of-care.
"Having that capability close to the patient, we think, is going to be a game changer," he said.
The company has developed a menu of tests for cardiac biomarkers at the point of care, including NT-proBNP to aid in the diagnosis and risk-based stratification of patients with suspected congestive acute heart failure. He said that point-of-care testing has become a focus for emergency medicine physicians because it lets them deliver care more quickly to improve outcomes.
QuantuMDx CEO Jonathan O'Halloran said that his firm has been developing a 2.0 version of the company's CE-IVD marked Q-POC point-of-care PCR instrument, and the new version will incorporate mass-multiplexing capabilities that will allow it to compete with the point-of-care offerings from BioMérieux's BioFire business and Qiagen. The firm plans to conduct clinical studies this year ahead of early 2025 submissions to the FDA for 510(k) clearance of the platform, and the firm plans to launch late next year a TB monitoring test that uses fingerprick blood samples to monitor six mRNA biomarkers of host immune response.
The firm currently markets a syndromic assay for the detection and differentiation of SARS-CoV-2, flu A/B, and RSV.
O'Halloran said that QuantuMDx is also developing a fingerprick-based sepsis test that would be used to detect host immune response and provide within 20 minutes a risk-based score of the likelihood that a patient will develop sepsis. The firm also has longer-term plans to develop syndromic infectious disease tests that incorporate the detection of markers for antimicrobial resistance.
"We think that the market's really going to be moving to multiplexing and antimicrobial testing in a big way over the next three to five years, and we really want to be positioned to be the lead player," he said.