NEW YORK – When MyCartis announced in August it was spinning off its point-of-care business into a separate company called Antelope Dx, company executives said that the reason was to focus on developing and commercializing a POC multiplex test for chlamydia, gonorrhea, and other conditions.
According to Antelope Dx Founder and COO Jan-Willem Hoste, if all goes according to plan, in about three years physicians will be able to use the company's tests in their clinics to evaluate patients, and consumers will use the tests at home.
"We felt that after an initial scale up, this was the perfect moment to spin off Antelope and give its tests the best chance of success," Hoste said in an interview.
Being part of a centralized diagnostic test developer has been valuable in accelerating the Antelope Dx platform development. In particular, having access to MyCartis' knowledge of assay development, quality initiatives, and regulatory activities has proved invaluable, and the two firms continue to collaborate and share facilities, Hoste said.
However, making Antelope Dx a standalone entity gives it the opportunity to establish its own identity, and as the firm seeks to "bring quality healthcare into the hands of people … business development knowledge, market access, and a branding strategy" specific to a point-of-care testing business were needed, he said.
Hoste and his colleagues began work on the Antelope Dx technology — which combines a photonic lab-on-a-chip with a lateral flow immunoassay testing architecture — as part of the photonics research group at Ghent University.
Using Flemish government and university funding, the researchers incubated the platform with a goal of building a system, developing a business proposition, and raising additional capital to bring the technology to the market.
Prior to Ghent, Belgium-based MyCartis taking on development of the platform at the end of last year, the researchers had spent about 10 years developing the technology. "We knew that we needed a system and the fabrication routes around the photonic chip that would allow decentralization of testing," Hoste said.
MyCartis provided additional diagnostic product development know-how and facilities to enable the Antelope Dx university researchers to continue their development work.
Each firm's immunodiagnostic system is different but the biological principals underlying testing on both platforms have similarities, Hoste said. Similar to the Antelope Dx platform, the MyCartis microparticle-based immunodiagnostic platform has a reader and cartridge. It uses microfluidics and multiplexing assays that provide rapid measurements and high sensitivity, Hoste said.
In parallel with announcing Antelope Dx's spin off, MyCartis said that Ghent-based RMM and Gooik-based Saffelberg Investments have led the investment of €5.1 million ($5.7 million) in the new company.
Hoste said that Antelope Dx, also based in Ghent, is looking to undertake clinical testing to validate its platform and assays in advance of seeking regulatory clearances. The firm will seek regulatory approvals to market all of its tests in Europe, and it is deciding whether to simultaneously seek US Food and Drug Administration clearances.
Antelope Dx is targeting the first half of 2022 for the release of its first chlamydia/gonorrhea multiplex test for use in homes and clinics. Its second test in development uses a panel of protein markers to differentiate viral from bacterial infections and could enable physicians to decide whether to prescribe antibiotics and could be available in the second half of 2022.
Similar to MDx platforms, the Antelope Dx immunodiagnostic system will provide multiplexing capabilities; the firm is developing the system to measure between 10 and 20 targets.
For its STI test, the firm aims for a clinical sensitivity of between 90 percent and 95 percent, and a clinical specificity of 95 percent.
Among Antelope Dx's core competencies are its ability to develop technology and then look for the appropriate commercial partners to take it to specific markets. The home testing market may require different sales channel partners than the market for physician office testing, Hoste said.
The firm is exploring partnerships with distributors and companies, including pharmacies, that have access to potential customers for at-home diagnostics, he said, adding, "We do not have the ambition to build a huge consumer or over-the-counter brand, but we are developing the technology" for such a brand.
The MyCartis announcement to spin off Antelope Dx came on the heels of a decision in mid-August by the FDA to grant a first of its kind 510(k) clearance permitting sale of Binx Health's point-of-care test to detect chlamydia and gonorrhea, enabling its use in the US in clinics that have clearance to run tests that are deemed moderately complex. The FDA clearance of the platform, which provides sample-to-answer results in about 30 minutes for the two STIs, has been referred to by some industry executives as a watershed moment for sexual health testing.
With increasing recognition of the importance of rapid testing at the point of care for sexual health applications, competitors are developing tests in anticipation of future market entry. For example, Johns Hopkins University recently funded Novel Microdevices, a firm working on a 20-minute CT/NG test. And SpeeDx is developing STI tests on Cepheid's FleXible Cartridge program.
For sexual health testing, Antelope Dx doesn't intend to compete head-to-head with providers of molecular instruments and tests used in centralized laboratories, Hoste said. Instead, he said the Antelope Dx system could actually drive sales of MDx instruments and assays because those instruments will be needed to perform follow-up tests to confirm positive results obtained with Antelope Dx's tests.
And as STI rates continue to grow, new testing modalities may be needed to address the problem, according to Anna Dixon, chief technology officer at Binx Health.
While low costs and fast time-to-results are important, so is high performance, "so it will be essential that tests like the Antelope Dx [platform] are able to accurately identify positive patients at levels already established in order to obtain good uptake and participate in the established market with confidence," Dixon said. "With over 350 million new STIs diagnosed globally every year, a community of entrants into the POC STI market is good for everyone and the Binx io platform will be the vital high bar against which others will be measured."
Citing World health Organization numbers, she noted that 1 million new STI infections are transmitted each day, necessitating new methods for tackling the growing epidemic. Companies such as Antelope Dx aim to use innovative technology to compress the sample-to-answer time from days to minutes, and simplify the testing process by bringing it to patients' living rooms.
Barbara Van Der Pol, president of the American STD Association and the director of a diagnostic lab at the University of Alabama at Birmingham School of Medicine, said in an interview that, in general, the Antelope Dx STI test "has the potential to be useful," but the price point of such tests needs to be in the range of $5 to $20. Especially as the price gets closer to $5 per test, a diagnostic platform could then "have an enormous impact on STI control efforts globally."
She noted that STI rates are highest among youth, the disadvantaged, and the marginalized. With better access to rapid and accurate tests, "we will have the opportunity to reduce stigma by placing agency in the hands of the user and making sexual health screening as normative as using condoms or performing a pregnancy test," Van Der Pol said.
Hoste said Antelope Dx expects that its chlamydia/gonorrhea multiplex tests — including the instrument and cartridge — will be available for less than €70 ($77) each. The cartridge is likely to be priced at between €10 and €15, he said.