NEW YORK – With the launch of two point-of-care molecular assays for sexually transmitted infections, Roche Diagnostics is preparing to enter a new commercial market.
The firm received 510(k) clearance and CLIA waiver from the US Food and Drug Administration for two assays last month, one that detects Chlamydia trachomatis, Neisseria gonorrhoeae, and Mycoplasma genitalium from a single sample and one that detects C. trachomatis and N. gonorrhoeae alone.
The assays run on the firm's Cobas Liat instrument, a PCR-based platform that is used in near-patient settings, like doctors' offices and urgent care centers, and return results in about 20 minutes.
The tests require minimal sample preparation. For vaginal swab samples, the swab is inserted into the Cobas PCR transport media, and that matrix is pipetted into the assay tube. For urine samples, the urine is collected in a urine collection cup and pipetted into the PCR media, where a small volume of media is then pipetted into the assay tube. No other sample preparation is required.
According to Ian Parfrement, head of the near-patient care customer area at Roche Diagnostics, Roche has an installed base of 8,000 Cobas Liat instruments across the US, largely within integrated healthcare networks and in decentralized settings. The majority of the menu on the Liat platform is for respiratory diseases, with some tests for hospital-acquired infections. The launch of the STI tests, he said, "marks the broader expansion of the menu."
"We see STIs as being a very significant unmet need … in the point-of-care area," he noted, adding STIs have been a key focus area for Roche's existing users and the expansion to STI testing is highly anticipated.
The STI rapid molecular testing market has been expanding in recent years, although many companies that were working on these tests before the COVID-19 pandemic refocused their development on tests for SARS-CoV-2 during its height. In 2019, Binx Health received FDA clearance for its Binx io instrument and an assay for chlamydia and gonorrhea. The Binx test takes 30 minutes to return a result, and the platform can multiplex up to 24 targets in one test.
Last year, Binx inked a US-wide distribution deal with healthcare services firm Cardinal Health for the Binx io platform and STI test.
Other rapid point-of-care molecular systems that have been cleared by the FDA and/or received CLIA waiver include Danaher subsidiary Cepheid's GeneXpert Xpress, Abbott's IDNow, and QuidelOrtho's Savanna. Of those, none offer tests for chlamydia, gonorrhea, or M. genitalium, although QuidelOrtho does have a test for herpes to which it plans to add a syphilis target, and the GeneXpert Xpress offers a multiplex vaginal infection panel.
Becton Dickinson, meantime, has begun clinical trials for its BD Elience point-of-care molecular platform and a CT/NG assay that can detect targets in 15 minutes.
Smaller companies are also moving forward as competitors in the space. Singapore-based Credo Diagnostics has developed a near-patient molecular diagnostic platform called the VitaSIRO Solo and plans to launch a four-target STI test in 2027, while Visby Medical's instrument-free PCR test for sexual health detects chlamydia, gonorrhea, and trichomoniasis and received FDA clearance and CLIA waiver in 2023. Detect, which uses loop-mediated isothermal amplification, is developing a multiplex panel for STIs, and Scout received $1 million in funding from the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator last year to develop its point-of-care molecular test for chlamydia and gonorrhea.
In Parfrement's view, the addition of M. genitalium in the Liat CT/NG/MG test is a key differentiator, although the reimbursement landscape is less established than for chlamydia and gonorrhea. It has similar symptoms to both chlamydia and gonorrhea, but the disease has different treatment pathways and "needs to be treated just as proactively" as chlamydia and gonorrhea.
"The three targets meet an emerging strong medical need," Parfrement said.
In 2021, the US Centers for Disease Control and Prevention updated its guidelines for the diagnosis and treatment of STIs to include the use of nucleic acid amplification-based tests to diagnose M. genitalium.
While the tests officially launched in the US last month, Parfrement said that they have received CE-IVD clearance as well, and the company intends to commercialize them in countries accepting the CE mark later this quarter. Roche also plans to "continue to work on market access and regulatory approval" for the rest of the world.
Liat menu expansion will not stop at STIs, Parfrement noted. Roche is looking to build out the Liat menu with whooping cough panels and lesion panels, although nothing else has yet received FDA approval.