NEW YORK ─ MatMaCorp is expanding into human diagnostic testing with the development of a molecular test for SARS-CoV-2 active infection that it anticipates will be affordable for rural hospitals and has the potential to broaden testing in an underserved population.
The firm was one among nine companies that recently received a total award of $129.3 million as part of the NIH Rapid Acceleration of Diagnostics initiative to expand testing and manufacturing capacity and to support development of new rapid SARS-CoV-2 tests.
Though the Lincoln, Nebraska-based firm is not disclosing the amount of NIH funding it has received, it said the award has supported its development of an RT-PCR system for the detection of SARS-CoV-2, which it has adapted from a testing platform it is supplying for agricultural diagnostic applications, such as the detection of congestive heart failure in cattle.
The company has completed validation of the SARS-CoV-2 molecular test and applied for Emergency Use Authorization to the US Food and Drug Administration.
MatMaCorp, founded in 2014, said its platform eliminates the time-consuming step of RNA extraction and with it a challenge that has hampered the availability of testing during the pandemic: a shortage of RNA extraction kit reagents.
During testing for SARS-CoV-2, about 2.5 microliters of a patient sample ─ either a nasal or nasopharyngeal swab in viral transport media ─ is treated with a lysis buffer and then introduced directly for testing, the firm said. The test system uses traditional RT-PCR to amplify the viral sequence and then verify whether the amplified sequence is specific to SARS-CoV-2 using a padlock probe specific to the SARS-CoV-2 RdRp gene. The padlock probe uses rolling-circle amplification and a fluorescent dye-labeled primer to detect the gene, the firm said.
Abe Oommen, MatMaCorp's founder, president, and chief technology officer, said in an interview that the company set out to "develop a method that eliminated RNA purification and was also very accurate." Without RNA extraction and purification, the system still provides levels of sensitivity and specificity similar to current RT-PCR testing systems, he said.
Its Solas 8 instrument, a four-channel fluorescence detector, looks for different targets in different channels enabling the detection of human internal controls as well as the virus in a single reaction. Small enough to fit in a backpack, the instrument provides results for active infection in one and a half hours, according to MatMaCorp. The device enables touch-screen control and provides step-by-step testing instructions so that it is easy to use and its data can be accessed and shared remotely via mobile phone or computer.
Though the company has developed its test system internally ─ including hardware, software, and SNP-calling algorithms ─ its technology originated with the advent of padlock probes in the early 1990s, Oommen said.
Padlock probes are long oligonucleotides, whose ends are complementary to adjacent target sequences. Upon hybridization to the target, the two ends are brought into contact, allowing padlock probe circularization by ligation. For COVID-19, the company designed a padlock probe that will ligate only if the SARS-CoV-2 sequence is present, using a comparatively small amount of sample, Oommen said.
Though the firm's testing platform is portable enough for point-of-care use, the company initially is not planning to place the test near patients in clinics and other CLIA-waived settings for which it would need to obtain a specific regulatory approval. Its highest priority is targeting instruments and test placements in CLIA-certified laboratories attached to critical-care hospitals located in rural communities that are a few hours driving distance from a reference laboratory, MatMaCorp CEO Phil Kozera said in an interview.
"Prior to the pandemic, our focus was solely on animal health and veterinary diagnostics," he said, "but because of the number of calls we received from colleagues in the rural community, we decided to develop a test for COVID-19. Our colleagues were either unable to get testing done because of the lack of availability or they had to wait too long ─ anywhere from seven to ten days ─ to get results."
As a result of the NIH program, MatMaCorp has been able to "put a structure around" its entry into human health testing, Kozera said.
The NIH Rapid Acceleration of Diagnostics initiative has been established to speed innovation in the development, commercialization, and implementation of technologies for COVID-19 testing. As part of the program, the NIH is working to expand testing development and distribution across the country in partnership with other government organizations such as the Biomedical Advanced Research and Development Authority, Centers for Disease Control and Prevention, Defense Advanced Research Projects Agency, and US Food and Drug Administration.
The NIH noted in a statement that the pandemic has created a need "for accurate, reliable, and readily accessible testing on a massive scale, and returning safely to normal life depends on the ability to streamline and speed up the testing process," including in underserved and vulnerable populations in rural areas.
If MatMaCorp obtains FDA EUA, it plans to manufacture instruments and test kits internally. Leveraging an internal sales team, it will aim to target placements of its molecular test at $9,500 per instrument that runs assays at about $30 per test, pricing that's more affordable than for current RT-PCR-based systems, Kozera noted.
The firm's Solas 8 instrument can test six samples per run, a level of throughput far lower than many current RT-PCR machines used in hospitals, which can process thousands of samples per day. But the instrument is still suitable for rural community hospitals that must provide testing but have comparatively lower test volumes, Kozera said. The instrument uses lyophilized reagents that operate at ambient temperatures and don't require refrigeration, an important consideration for rural point of care use, he noted.
Despite being "pivotal to opening up communities," most rural hospitals have tighter budgets that preclude them from purchasing more expensive platforms that are on the market, and many are finding it challenging to gain access to the level of testing that meets demand, Kozera noted.
Kearney Regional Medical Center, an acute-care 94-bed hospital in Kearney, Nebraska, is beta testing MatMaCorp's molecular test system and encountering such challenges.
Use of MatMaCorp's molecular platform can help the hospital provide better service to its patients "with accurate, timely testing" and the assurance that it is not going to be placed on allocation, Tori Seberger, a medical laboratory technician at the hospital, said in an interview.
Kearney Regional is limited in the amount of testing it can do by its reference laboratory, Regional Pathology Services, and its rapid testing vendor, Danaher's Cepheid, she said.
Its allocation of about 50 tests per week from Cepheid limits the hospital to testing specimens collected from patients being admitted to the hospital to determine whether they need to be isolated. With its weekly allocation, the hospital also needs to test its essential workers to keep staffing levels at appropriate levels for patient care, Seberger added.
The hospital sends all non-stat COVID-19 testing requests to Regional Pathology Services and receives most results in between 48 hours and 72 hours from the time the lab receives the specimen. That's an "unacceptable timeframe for many of those being tested," Seberger noted.
Kearney Regional can better reduce the rate of infection by rapidly isolating people who have SARS-CoV-2 and "allowing healthy people to return to work and stay productive" with use of MatMaCorp's testing system, she said.
As the firm's business expands, it may also expand its internal sales team or look to engage with a distributor. For its product pipeline, the company is considering developing a multiplex respiratory panel that includes SARS-CoV-2, flu A, and flu B among its targets, and it is exploring the potential to develop new molecular platforms that may be suitable for over-the-counter testing.