NEW YORK – True qPCR at the point of care is a rarity, but startup Kryptos Biotechnologies believes its novel engineering combined with a collaboration with a South Korean diagnostics developer will give its Kuick system a competitive leg up that will translate to successful adoption.
Kryptos announced last week that it won a product development grant from the RIGHT Foundation — a nonprofit funded by the Bill and Melinda Gates Foundation and the government of South Korea — to help it craft a 20-minute, CLIA-waived qPCR assay for sexually transmitted infections suitable for use in low- and middle-income countries.
The STI work will be done in collaboration with early investor Osang Healthcare, also called OHC, Kryptos CEO Jinyong Lee said in an interview. The firm has its sights set on the broader point-of-care market, as well, Lee noted, and expects its technology to offer advantages in clinics and emergency departments compared to other commercial offerings.
Hayward, California-based Kryptos was cofounded in 2017 by Jun Ho Son, a former staff scientist in the laboratory of Luke Lee at the University of California, Berkeley. Son pioneered a method called ultrafast photonic qPCR that merges an optically thin material, microfluidic cartridges, and photothermal heating using LED lights.
The technique can generate temperatures in the range of 100 degrees Celsius needed for qPCR, Lee said, while obviating the need for more typical heating elements that tend to increase manufacturing costs.
Photothermal PCR is not new, per se, however, "most of the previous approaches use a high-powered light source, like a laser diode," Lee said. "We use LED light — which is very cheap, and very stable — and combined with a thin material, the method very efficiently converts light to heat," he said.
At Kryptos, Son and colleagues have also further developed the method to perfect the cartridge and test instrument, Lee said, including adding proprietary integrated sample preparation.
The funding announced last week, totaling $1.2 million, also stipulates collaboration with South Korea's OHC to develop the qPCR assay. In the US, Osang is perhaps best known as a supplier of immunoassays, and during the pandemic, it supplied 100 million COVID-19 tests to the US government.
Dan Lee, CEO of Osang's US division, said this accounted for 40 percent of its total sales, adding that OHC projects its US sales to grow to approximately half of its total revenues in 2025.
This week, Osang received US Food and Drug Administration clearances for two combination antigen tests to detect COVID, influenza A , and influenza B — one for professional use and the other for over-the-counter use. Osang's Lee noted that this marked the first combo COVID/flu antigen test clearance for professional use and the second OTC combo test clearance following Healgen Scientific's de novo clearance in October.
Now, "we are collaborating with one of the largest IVD companies to distribute our tests in the US," Osang's Lee said in an email but did not specify the collaborator.
Meantime, in the qPCR space most of OHC's assay revenue comes from European countries, Osang's Lee said, but the firm hopes that partnering with Kryptos will help it to expand its molecular business, leveraging Kryptos' platform technology alongside its capability to mass-produce and design molecular reagents.
In April last year, OHC led Kryptos' $10 million Series A financing round, and Osang's Lee noted that this was motivated by the firms' "shared vision to advance point-of-care molecular diagnostics."
Osang's molecular tests are differentiated in the market by the firm's capability to design and produce the reagents and all-in-one cartridges in-house leveraging its proprietary lyophilization tech.
"By integrating these strengths with Kryptos’ photothermal PCR technology, we aim to establish ourselves as the industry leader and first mover in the rapid molecular diagnostics POC segment," Osang's Lee said.
Molecular testing has been recommended for chlamydia and gonorrhea, and a number of players are vying for the growing POC and at-home markets, including startups like Detect, Visby Medical, Scout, Midge Medical, Prompt, Credo Diagnostics, and Aptitude Medical, while the more established firms eyeing the space include OraSure and Becton Dickinson.
But Kryptos' Lee noted that, currently, only a few CLIA-waived POC systems are commercially available that can perform true qPCR at the point of care, namely those manufactured by Roche and Binx Health. Roche launched the Liat in 2015, has been gradually expanding the menu ever since, and earlier this week, it obtained clearance and CLIA waiver for a test on the Liat to detect and differentiate chlamydia, gonorrhea, and mycoplasma in approximately 20 minutes.
Binx, meanwhile, was the first manufacturer to get a CLIA waiver for a POC test to detect sexually transmitted infections back in 2019, and raised $65 million last year in a Series F round to refocus its business on the point of care.
There are also qPCR-based systems that tend to operate more in the "near-patient" space, such as the Cepheid GeneXpert, as well as Visby Medical's handheld test that use endpoint PCR. Meantime, others leverage rapid isothermal technologies, such as in the Abbott ID Now system.
But Kryptos thinks its system will be unique because it will offer the speed required for test-and-treat approaches at the point of care with the accuracy of qPCR and at a low cost.
The Osang collaboration also engenders advantages in terms of manufacturing and distribution, Kryptos' Lee said.
In particular, "they have very strong manufacturing capabilities … and they've already started to give us a line for our first product," he said.
Kryptos also expects to offer a wide testing menu in collaboration with Osang, including tests for strep A and other infectious diseases.
As it continues to develop the STI assay, its first commercial test is expected to be a multiplex assay for COVID-19, influenza A and B, and respiratory syncytial virus.
Kryptos plans to enter clinical trials later this year with its respiratory test and complete them by the end of the respiratory virus season in early 2026.