NEW YORK ─ Maxim Biomedical this week is evaluating data from an undisclosed number of symptomatic and asymptomatic SARS-CoV-2 patient samples as part of a clinical study to validate a single-use antigen test it believes would provide results at the point of care in 15 minutes.
The firm expects that the data from its validation study will enable it to apply within two weeks to the US Food and Drug Administration for Emergency Use Authorization, Jonathan Maa, the company's chief operating officer, said in an interview.
If the FDA grants EUA, Rockville, Maryland-based Maxim Biomedical expects to produce a few million antigen tests before the end of this year and between 15 million and 20 million tests per month starting next year.
To gain acceptance in the market, the company has eliminated the use of an instrument and designed an assay with user safety and convenience in mind.
Maxim Biomedical's test strip uses proprietary detection nanoparticles conjugated to antibodies that target the SARS-CoV-2 nucleocapsid protein in a nasal swab sample to ascertain whether the test is positive or negative. The design enables a healthcare worker to take a nasal swab from a patient, insert the swab in the test tube that contains a reagent, and then break the swab so that the tube can be closed. Prior to closing the tube, the test strip is also inserted.
A change of color indicates a positive or negative result that can be accessed for up to two hours after taking a test, according to Maxim Bio.
"As a result, you have a system that removes the element of potential spillage and exposure for the healthcare provider," Maa said. "The test's key advantage lies in its simple, but functional design that would make it easier and safer to use than many other tests in the market."
Maxim Biomedical was recently awarded an undisclosed amount of funding to further develop and validate its test through the National Institutes of Health Rapid Acceleration of Diagnostics (RADx) initiative, which aims to support the commercialization of new tests and bring technologies to market within six months that would normally take years to develop and launch.
Through the RADx program, Maxim Bio is also receiving regulatory advice from the NIH.
The firm, founded in 2005, develops tests using different diagnostic technologies ─ including PCR-based assays, antibody-based ELISAs, and lateral flow assays ─ and develops tests for other manufacturers, including startups and multibillion-dollar organizations, according to Maa. It also sells an HIV test it developed and for which it has obtained FDA premarket approval.
In collaboration with the US Centers for Disease Control and Prevention, the company is developing a rapid lateral flow test that differentiates between recent infection and long-term HIV infections.
In March, the US Department of Defense, one of its customers, inquired about the potential for a rapid antigen test for SARS-CoV-2 detection, Maa said, and as a result, the firm developed the current antigen test and requested that NIH include it in its RADx program. The program is "helping us fund our scaleup to make sure that we can deploy millions of tests in the US market as soon as possible," Maa said.
Though it hasn't yet received FDA EUA for the antigen test, the firm is ramping up manufacturing. To expand capacity, the company is collaborating with Team Technologies, headquartered in Morristown, Tennessee, which provides manufacturing services for healthcare companies that include IVD manufacturers.
"We expect rapid antigen tests to enable quicker decisions and better clarity for patients and their physicians," Marshall White, Team Technologies' president and CEO, said in an interview. "From what I've reviewed and seen in the lab, this is a very effective test and we expect the clinical studies to confirm that."
Team Technologies has ordered new capital equipment and is repurposing existing equipment to help ramp up manufacturing, White said. "It's a challenge because we are working with a compressed timeline, but we have developed a phased approach to be able to deliver at the expected run rate," he said.
Performance levels for Maxim Biomedical's test will contribute to whether the firm obtains EUA, and assuming EUA success, how well the test will be accepted in the market.
Based on validation testing, the firm believes the performance of its antigen test will rival those of the highest-performing "tests currently in the market," Maa said. Specific levels of sensitivity and specificity are not yet available because they are being established during the clinical studies, he said, adding, however, that the company has already completed independent validation testing with the US Department of Defense, Emory University, Northwestern University, and the University of Massachusetts that has given it confidence to proceed with preparations for manufacturing.
Generally, concerns have surfaced about the potential for false negatives from antigen tests because the level of accuracy is less than that of highly sensitive RT-PCR SARS-CoV-2 tests. But many observers also view antigen tests as being vital to helping mitigate the pandemic and open up economies, enabling testing at the point of care in a variety of settings, including community clinics, school campuses, long-term care homes, and airports.
Thus far the FDA has granted EUA for six antigen tests, five of which are used to test specifically for SARS-CoV-2, and one developed by Quidel that tests for SARS-CoV-2 and influenza.
Quidel's Sofia SARS Antigen test has shown nearly 97 percent sensitivity and 100 percent specificity, according to documents filed with FDA, and Abbott's BinaxNow COVID-19 Ag Card has shown 97 percent sensitivity and nearly 99 percent specificity.
Siemens Healthineers last week announced that it had received CE marking for an antigen test that it said is easy to administer for healthcare professionals who collect a nasopharyngeal swab and insert it into a tube with a liquid to extract the target molecule. The sample is then dispensed onto a test cassette that indicates a positive or negative result.
The firm has launched the test in Europe and other regions that accept the CE mark and anticipates applying for an FDA EUA.
Of the antigen tests that have obtained EUA, Maxim Bio's is most like Abbott's BinaxNow assay because neither one requires an instrument, Maa said. Eliminating a reader has contributed to Maxim Bio being able to keep the price competitive with other antigen tests on the market, he said, but he is not yet disclosing pricing.
Depending on the results of validation testing, the company may seek an authorization that will enable testing of patients that are asymptomatic as well as symptomatic, Maa added.