NEW YORK (360Dx) – Belgian diagnostics firm MyCartis is taking aim at the point-of-care testing market with the development of its Antelope Dx platform.
Based on a silicon photonics technology developed at Ghent University, the system could enable the use to rapid, multiplexed immunoassays in the point-of-care setting but at levels of performance comparable to that provided by a conventional clinical analyzer, said Jan-Willem Hoste, a senior scientist at Ghent University and one of the inventors of the platform.
Hoste led development of the system working under Ghent University professor Peter Bienstman in the photonics research group headed by professor Roel Baets. The researchers formed a spinout, Antelope Dx, to commercialize the technology. MyCartis announced this month that it had acquired the platform.
Hoste said MyCartis has as its initial focus for the platform two tests — one a sexually transmitted infection test for diagnosing gonorrhea and chlamydia, and another for distinguishing between acute bacterial and viral infections.
He said the company aims to launch the STI test in 2021 for home use and to launch the test for distinguishing between bacterial and viral infections for use in doctors' offices shortly thereafter.
Hoste said the STI test will address the desire of patients to access such testing without involving their doctor or other outside party.
"When we look at what propositions make the most sense [for a POC platform], we see that for STIs there is a very big threshold for patients to get over in terms of shame and embarrassment," he said. "People have a clear desire to have a test they can use at home without having to interact with the healthcare system."
Demand for the bacterial versus viral infection test comes primarily from physicians who would like to be able to quickly assess whether or not a patient should be treated with antibiotics, Hoste said.
For both tests, MyCartis is focused primarily on converting existing assays and markers to the Antelope platform, as opposed to discovering new markers, said Wouter Laroy, chief science officer at MyCartis.
"I think we consider the most innovative part of Antelope to be the [biosensor] technology itself, not discovering or inventing new biomarkers or biomarker panels," he said.
In the case of the planned STI test, there exist established markers that are effective at diagnosing gonorrhea and chlamydia. Markers also exist for distinguishing between bacterial and viral infections, but their effectiveness is debatable. For instance, while the markers C-reactive protein and procalcitonin are commonly used to determine if an infection is viral or bacterial, their effectiveness is still a matter of debate.
For instance, in an interview earlier this year, Nathan Ledeboer, medical director of clinical microbiology at the Medical College of Wisconsin, noted that while procalcitonin initially showed great promise, this promise has dimmed somewhat as it has been tested in larger and more diverse patient cohorts.
"Whether people use procalcitonin or not really comes down to the question of what study you believe," he said.
MyCartis will have competition for both tests. Several companies are pursuing STI home testing, including Los Angeles-based MyLabBox, which offers direct-to-consumer testing for STIs including chlamydia, gonorrhea, HIV, herpes, syphilis, and human papillomavirus; and Dublin-based LetsGetChecked, which closed a $12 million Series A funding round in March and offers tests covering various STIs including chlamydia and gonorrhea.
On the bacterial versus viral front, the company will face competition from tests like Thermo Fisher Scientific's BRAHMS PCT POC assay and the MeMed BV test from Israeli diagnostics firm MeMed. That firm has also developed a proprietary POC testing platform, the MeMed Key, on which it plans to run the BV test along with other POC assays.
Hoste said MyCartis plans to sell the Antelope Dx testing system for under €100 ($114) with the assays themselves running around €10 per test, with the cost varying with the number of markers comprising a test. He said the system will be able to multiplex in the range of 10 to 20 analytes.