NEW YORK – Molecular diagnostics startup Detect plans to pivot to sexually transmitted infection testing soon after completing a series of clinical validations.
The Connecticut-based firm is partnering with Planned Parenthood and the AIDS Foundation to help assess its 15-minute multiplex molecular tests with eyes toward beginning clinical validation studies in the next few months to support a US Food and Drug Administration submission.
Detect's technology was developed by Jonathan Rothberg and Hugo Barra, a consumer hardware engineer and former executive at Google and Meta, in an effort to help combat the COVID-19 pandemic.
Initially known as Homodeus, the company was founded in Rothberg's 4catalyzer tech incubator; 18 months later, it was one of three companies to obtain Emergency Use Authorization for an over-the-counter molecular SARS-CoV-2 test.
Detect relies on loop-mediated isothermal amplification (LAMP) and a simple instrument to make its testing low cost, rapid, and easy to use, according to Owen Kaye-Kauderer, the firm's cofounder and chief product officer.
Although LAMP is a commonly used technology, Detect has made a number of improvements to the reaction over the last few years, Kaye-Kauderer said in a recent interview.
Historically, LAMP has challenged diagnostics developers in terms of the primer design and the speed of the reaction. But the Detect team uses an artificial intelligence-based primer design tool to help create very sensitive and specific tests. Testing also incorporates proprietary biologics, such as enzymes that the Detect team designs and builds themselves, which in turn can yield results more quickly and accurately, according to the company.
Taken together, "that gives us an advantage compared to others taking a similar approach," Kaye-Kauderer said.
The company claims to have ultimately placed more than 30,000 of its Hub test instruments with businesses and consumers, sold more than 250,000 COVID-19 tests, and raised more than $100 million in capital.
In late 2021, Detect was awarded $8.1 million from the National Institutes of Health's Rapid Acceleration of Diagnostics (RADx), and in early 2022, Detect was awarded $22.9 million from the US Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA) to further develop its COVID-19 and influenza A/B combo test.
The Detect EUA COVID-19 test remained on the market through the Omicron surge and into the end of 2022. Then, Detect decided to take the EUA product off the market.
The goal was "to focus on using the same technology to create a much broader menu of applications and update the system to make it even faster, easier to use, and more sensitive," Kaye-Kauderer said.
The firm recently reemerged from this R&D mode with an updated, point-of-care system and a new menu strategy involving multiplex molecular tests.
"Our focus is on making the cost of goods for the system extremely low, and the way to achieve that is to make the hardware as simple as possible," Kaye-Kauderer said. For example, to simplify processing, the instrument runs parallel reactions to enable rapid multiplexing, as opposed to running single-tube reactions.
Detect is now pushing forward on two initial isothermal multiplex panels — one for respiratory viruses and one for sexually transmitted infections.
With a legacy in COVID testing, sexually transmitted infection testing served up a sample prep challenge. Unlike spit or snot, vaginal matrix can require additional sample prep steps to make any pathogens within accessible. "It's probably the biggest technical challenge that needs to be overcome for an STI test," Kaye-Kauderer said.
Detect has solved this problem by developing a very low-cost, miniaturized sample prep element for its system. The overall test cartridge is essentially made from very simple plastic fluidic components, he said, shifting any complex electronics or motors from the cartridge to the hub to reduce cartridge cost.
This is in part because Detect's initial target customers are point-of-care testing sites like physician offices, urgent care centers, nursing homes, and pharmacies. Kaye-Kauderer said these customers tend to be very sensitive to the recurring cost of consumables, but much less sensitive to the upfront cost of the testing instrument itself.
Nevertheless, Detect expects its platform to be significantly less expensive than other point-of-care systems that are currently commercially available, although Kaye-Kauderer declined to specify the estimated price.
Going forward, Detect is also hoping to target the pediatrician office space for its respiratory panel and a possible strep throat assay. And, it plans to offer an update to the STI panel in the future to detect certain SNPs in gonorrhea bacteria that make it resistant to a low-cost antibiotic called ciprofloxacin.
POC STI MDx
Firms such as Sherlock Biosciences, Cue Health, Novel Microdevices, Lucira Health (recently acquired by Pfizer), and Aptitude Medical have all declared their intent to enter the point-of-care STI testing market, as well. And, a 30-minute PCR test from Visby Medical is FDA-cleared and CLIA-waived to detect CT/NG and Trichomonas, while QuidelOrtho is developing a multiplex STI panel for its recently cleared Savanna point-of-care PCR system.
At-home, over-the-counter STI testing is a long-term goal for many of these firms, as it is for Detect, but Detect will prioritize the point-of-care market first, Kaye-Kauderer said.
"There is a very strong need there," he said. Between 35 million and 50 million chlamydia and gonorrhea screening tests are performed each year in the US. This is in part due to guidelines recommending annual screening for many sexually active people and even more frequent screening for certain at-risk populations.
Kaye-Kauderer also said that half of women who are eligible for screening are not screened properly each year, "so there is a lot of undertesting."
Furthermore, the delays associated with lab-based testing can lead to a patient remaining untreated and possibly spreading the infection, or to proactive "best guess" treatments that ultimately prove inappropriate, leading to unnecessary cost, side effects, and possible development of antimicrobial resistance.
"With our track record of having brought a product to market so quickly and innovating with technology, we're confident that we're going to produce the best platform here," Kaye-Kauderer said.
For point-of-care testing, Detect plans to approach physicians with messaging about the affordability of the system and the potential for billing using existing reimbursement codes, Kaye-Kauderer said.
An alternative approach to tackle these same issues might be at-home collected samples that are mailed to a lab, as in the case with LetsGetChecked — the first test to receive FDA clearance for at-home sample collection — or Binx's recently divested digital health offering.
For over-the-counter testing requiring consumers to maintain their own test instrument at home, Cue Health might be an example of a platform launched during COVID using this approach that has since faced some challenges.
Kaye-Kauderer said that for healthcare consumers with large families or school-age children that get sick often, keeping a testing hub at home might make a lot of sense. But the price of the instrument is the key. "If the economics don't make sense for a customer, then it's not going to be sustainable, and so that's why we're really focused on cost."
To help with the development of the STI testing, Detect is partnering with the AIDS Foundation and Planned Parenthood.
For example, Detect partnered with the national Planned Parenthood Research Network to complete a study that supports the development of the Detect STI test.
Lisa Della Badia, director of Affiliate Research at Planned Parenthood, said in an email that PPRN was established in 2002 and has over 30 participating sites that coordinate with approximately 400 health centers across the US. The overall network is managed by the Planned Parenthood Federation of America through its Research and Evaluation department, and PPRN's projects are centrally coordinated and managed.
With Detect, the PPRN will help to validate the rapid molecular STI assay by recruiting and testing approximately 2,000 participants from four Planned Parenthood sites.
Detect also plans to continue working with Planned Parenthood's clinics once it begins the clinical validation studies that are required to obtain FDA clearance. The firm expects this stage of the process to begin in the next few months.
Della Badia noted that Planned Parenthood performed more than 3.7 million STI tests last year alone. "Almost all of these tests are sent to a lab for testing," she said, and that meant some results took a few days or even a few weeks. "With a rapid, portable molecular test, patients and providers could get test results in real time, allowing for more immediate treatment," she said, potentially improving health outcomes for patients who might otherwise defer or delay treatment or skip testing altogether.