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Co-Diagnostics to Seek FDA EUA for At-Home PCR Diagnostic System, COVID Test in Q1


NEW YORK – Molecular diagnostic kit developer Co-Diagnostics anticipates that its merger last month with assay and instrument developers Idaho Molecular and Advanced Conceptions Incorporated will soon culminate in a platform for at-home PCR testing using small, multiplexed panels.

The newly joined firms have been collaborating for the past year on a PCR platform called the Eikon and an assay for COVID-19. The team has already performed usability studies and is on the precipice of beginning clinical trials toward an Emergency Use Authorization submission to the US Food and Drug Administration. The firm expects to submit for an at-home indication in the first quarter of this year.

The cartridge-based Eikon instrument performs multiplex qPCR of up to six targets, with fluorescent readouts interpreted by cloud-connected software. It delivers a diagnostic result in 30 minutes and is expected to cost in the $300 range, with a test cartridge price of approximately $15 to $20. Eikon is also portable and amenable to personal use, being shaped like a tapered five-inch cube.

Co-Diagnostics began developing a SARs-CoV-2 assay kit in January 2020, and was the first US developer to obtain a CE mark for a COVID-19 assay in February of that year. Two months later, it was among the first to obtain EUA for a lab-based test.

However, Dwight Egan, Co-Diagnostics' CEO, said in a recent interview that even then he could see the pandemic would soon advance the frontier of home-use molecular testing.

Egan said he believes the "trifecta" of low cost, rapid results, and true gold-standard PCR will set the Eikon platform apart from potential at-home testing competitors, and also make it more broadly accessible. The firm also expects to offer the system to various point-of-care testing markets.

Early on the path to developing Eikon, Co-Diagnostics set about to adapt its CoPrimer technology to a lyophilized format that would enable tests to work directly from saliva. CoPrimers are a proprietary chemistry that attaches primers to probes with a polyethylene glycol-based linker. In a 2014 Journal of Molecular Diagnostics proof-of-concept study, they were shown to reduce nonspecific PCR amplification by a factor of 2.5 million.

Co-Diagnostics next sought out an in-development instrument that it could accelerate toward potential home use, Eagan said. The Salt Lake City-based firm discovered what it was seeking a mere four miles away, at Idaho Molecular.

The teams were already somewhat acquainted, as cofounder of Idaho Molecular, Kirk Ririe, had co-authored a commentary on the JMD study, deeming CoPrimers "an important technical contribution" to the field of nucleic acid amplification.

Ririe founded Idaho Molecular along with PCR authority Carl Wittwer. The two had previously founded a firm called Idaho Technology which developed the LightCycler PCR system that was acquired by Roche. Idaho Technology then developed the FilmArray system for syndromic molecular testing, rebranded itself as BioFire Diagnostics, and was ultimately acquired by BioMérieux.

When Ririe and Wittwer founded Idaho Molecular in 2020, it was essentially an incubator, Ririe said. The team soon began collaborating with another firm in the incubator, Advanced Conceptions, which was also founded by ex-BioFire employees.

"They were working on the hardware side, and Carl and I came in more on the chemistry side of the platform," Ririe said.

According to Egan, Co-Diagnostics approached this team for a collaboration because, for small PCR device design, they were arguably "the very best ... not only in Utah but in the entire world."

The teams worked side by side in 2021, Egan said, culminating in the Eikon instrument.

Then, "We made the decision ... that we would be in a much stronger position going forward if we could have a fully integrated company," Egan said, rather than paying ongoing royalties or having IP for a flagship product that was not fully owned and in-house.

In December, Co-Diagnostics merged with the two firms through an offer of 4.72 million shares of newly issued common stock and 465,000 common warrants, thereby acquiring all existing and future assets and intellectual property related to the platform.

Detailed specs and spaces

Eikon processes a single sample but is capable of performing low-plex testing enabled by CoPrimers and fluorescence detection, according to Ririe.

The assays have fluidic elements, he said, but more like "macrofluidic" rather than microfluidic. The sample prep component on the instrument is not a classical extraction, but more of a sample treatment prior to PCR, Ririe said. He declined to provide details on the precise mechanism of thermal cycling the instrument uses except to say that it is not the extreme PCR that Wittwer has pioneered.

Although the Eikon system can report multiple Ct values, whether that will be needed by customers or amenable to the FDA is not yet known. That said, the fact that test results are cloud-based engenders epidemiological tracking, Egan noted, which might make it more appealing to regulators and hospital labs overseeing point-of-care testing.

Overall, the system has been designed so that "it can live in the same room as your toothbrush," Ririe said. In the home environment, the risks of PCR might be paradoxically lower, he said, than for example in a reference lab that processes hundreds of infectious samples per day.

The firm's next plans after COVID testing are to launch panels on the instrument, for example to simultaneously test for influenza A and B along with respiratory syncytial virus and COVID-19, all in a single cartridge.

In addition to home use, Egan envisions the Eikon being used at sites like schools, and physician and dentist offices. Enabled by the low cost, it could also be used in "every room of a hotel or every stateroom of a cruise ship," to monitor for infectious diseases.

And, Eikon could find a home in places like India — where the firm already has a presence and 11 assays with regulatory approval, Egan said — by potentially turning rural diagnostic labs into molecular labs at a low price point, with low test cartridge prices.

"This is a long ball for Co-Diagnostics," Egan said.

No small potatoes

Wittwer and Ririe have collaborated for more than 30 years, first at University of Utah, then at BioFire/Idaho Technology, and most recently as cofounders of Idaho Molecular.

But Ririe takes the blame for the Idaho naming scheme, which he said sprouts from the fact that Idaho Technology was initially incubated at his parents' potato equipment company. "I believe that the world takes itself too seriously," he explained. "We've always taken a very lighthearted approach."

Although Idaho Technology was a humorous reference to his "spud country" origins, the firm moved to Utah in 1999 after licensing the LightCycler platform to Roche. When it began very seriously developing the FilmArray in 2012, the company was renamed BioFire. It was subsequently acquired for $450 million in 2014 by BioMérieux.

Then, "We spent years working with BioMérieux very closely to help make that platform a worldwide success," said Ririe. He retired from his position as chief innovation officer at BioMérieux in 2019.

In 2020, Ririe and Wittwer launched the "even sillier-named" Idaho Molecular, or IdMo as he calls it, and began working with the equally tongue-in-cheek-named Advanced Conceptions Incorporated.

All joking aside, the FilmArray has consistently provided molecular diagnostics revenue growth to BioMérieux, with a current tally of 21,400 systems placed worldwide. Ririe highlighted that syndromic molecular testing is now widely adopted, and it is making a difference in patient care, in part by performing "extremely well" at distributed settings.


Although many small qPCR and isothermal molecular testing instruments emerged during the pandemic, Ririe believes Eikon has a leg up.

Relative to small isothermal systems for home-use testing — from Lucira Health, Cue Health, Detect, Talis Biomedical, and others in development — the fact that firms have advertised them as "PCR-like" essentially acknowledges that PCR is the gold-standard technology, he said.

And, two years into the COVID-19 pandemic, "the fact that your best option at home is to buy a rapid antigen test ... [shows] no one has gotten this right yet," Ririe said.

Eikon's capability for robust multiplexing — enabled in part by the CoPrimer technology — also differentiates it from isothermal assays, Egan said.

Compared to other small multiplex PCR instruments — such as the Quidel Savanna, Meridian Revogene, QuantumDx Q-POC, or Scope Fluidics PCR One — Eikon is differentiated in part by the fact that it will be more focused on the home testing environment.

At-home molecular infectious disease testing is a step in a different direction from the syndromic testing of the FilmArray, but Ririe said that PCR in the home is inevitable.

"I believe 100 percent that PCR technology will eventually live in the spaces we're talking about here," he said. "I cannot guarantee that we'll succeed in being that platform, but that is our clear aspiration and we think we have a real chance of accomplishing it."

Ririe will now serve as president of the wholly owned subsidiary, while Wittwer will serve as chairperson of the scientific advisory board at the merged entity, leading the scientific mandate of the company going forward.

"One of the great pleasures of the last year has been to watch Dr. Wittwer and to see his mind at work," Egan said. "We really believe that this is a platform, software, and cloud-based system that is a revolutionary device," he added.

Egan noted that Co-Diagnostics currently has no debt and "a lot of money in the bank," which gives the firm "a tremendous amount of flexibility" in charting its own path to commercialization in the near term.