NEW YORK – After receiving Emergency Use Authorization from the US Food and Drug Administration earlier this month, Minute Molecular Diagnostics is working on the launch of its rapid COVID-19 test and instrument for later this year.
Targeting a Q3 launch date, the Northwestern University spinout is in the process of lining up manufacturers and commercial partners to prepare its rapid PCR test for COVID-19 and portable Diagnostic Analyzer for Specific Hybridization, or DASH, system, said Wally Narajowski, the firm's chief operating officer.
When it does, it will mark a milestone for the firm which has been working for five years to get to this point. David Kelso, the company's CEO, and Sally McFall, its CSO and director of research at Northwestern's Center for Innovation in Global Health Technologies, have been working together since 2006 on developing diagnostic technology, primarily for low- and middle-income countries, McFall said in an interview.
In 2015, Kelso began developing the analyzer, which was originally intended for the doctors' office market, and formed Minute Molecular in 2017. Then the COVID-19 pandemic hit, and like so many other diagnostic companies, Minute Molecular pivoted to developing a SARS-CoV-2 test, McFall said. The pandemic accelerated the development of both the DASH instrument and the test cartridge, while a $21.3 million contract from the US National Institutes of Health's Rapid Acceleration of Diagnostics program in April 2021 further sped things along, she added.
Additional funding for the company came from private investors and NIH's National Institute of Biomedical Imaging and Bioengineering, and the firm has raised $8 million so far.
To run the DASH SARS-CoV-2/S test, a user inserts a nasal swab into the single-use cartridge and puts the cartridge into the analyzer, which performs the PCR process and returns a result. While the total assay time is about 15 minutes, Narajowski said that the actual RT-PCR step is only about five minutes — the sample extraction and concentration make up the bulk of the assay's run time.
Although both Narajowski and McFall declined to go in-depth on how exactly the test is able to complete RT-PCR in only five minutes, citing proprietary technology, Narajowski noted that there is "magic in the chemistry." The cartridge itself is "thin-walled" and the instrument has fixed temperature heaters, allowing for rapid heat transfer and the ability to run 40 cycles in five minutes, he said. And though the swab and cartridge are both single use, the "instrument life is years," he said.
Another asset, McFall said, is that the swab goes directly into the cartridge without a viral transport medium, making it easier to concentrate the viral particles. In the studies conducted for the firm's EUA submission, the test and analyzer detected 47 out of 49 positive samples and had 98 percent specificity, McFall said.
Moving forward commercially, Narajowski emphasized that Minute Molecular is "fundamentally a virtual company," outsourcing everything to other firms except for test and technology development, which will continue in McFall's laboratory at Northwestern.
To get the test and analyzer on the market, the firm is working with contract manufacturers who will make the analyzer, cartridges, and reagents, and it plans to partner with a larger diagnostic company to commercialize the test, Narajowski said. Minute Molecular is in "final discussions" with the undisclosed partner.
The partner will be in charge of marketing, sales, and distribution for the test and analyzer, and once the partner is on board, the firm will finalize its regulatory strategies, Narajowski said — although he noted that it will likely target CE marking next, with a 510(k) submission to the US FDA next year. He added that the company will be looking into requirements for Europe's new In Vitro Diagnostic Regulation after the test's US launch.
Pricing will also be dependent on the partner, but he said that it will be "competitive" with other rapid molecular tests available and would use existing COVID-19 reimbursement codes. Although Narajowski didn't specify other competitors, there are multiple rapid point-of-care molecular systems with COVID-19 tests available in the US, including the Roche Cobas Liat and the Cue Health Monitoring System.
Narajowski said the test is intended for use at the point of care, particularly in emergency rooms, urgent care centers, and doctors' offices, although it is authorized for use in both CLIA-certified labs and CLIA-waived settings. He added that potential customers have shown interest in using the test in emergency rooms and conducting utility studies. A potential future embodiment of the COVID-19 test could be optimized for pooled sampling, with a six-in-one cartridge to allow for higher-throughput testing, Narajowski said.
As of now, there are no plans to seek authorization for use of the test or analyzer at home, he noted.
The Evanston, Illinois-based company has other tests in the works, too. Narajowski said the firm has a "road map" of 26 different tests to put onto the system, including a COVID-19 and influenza A/B combination test, a group A Streptococcus assay, and a tuberculosis test. The platform can also run a variety of different specimen types, McFall said, opening the company up to more kinds of assays.
Minute Molecular is targeting the completion of EUA studies for the combo COVID-19/flu test by the end of this year and the launch of the strep A test next year, Narajowski said. Any launches after that will depend on the commercial partner, he said.
Regardless of what test comes next, the company's current focus is on COVID-19, and it believes "having this test is going to really help in the fight against COVID," particularly in light of the increasing availability of new drug therapies for the virus, Narajowski said. The assay's sensitivity and rapid turnaround time can ensure patients receive the treatment they need as soon as possible, he added. "The key is that this is real lab-quality PCR at the point of care."