FDA Grants 510(k) Clearance to Roche’s Cobas Liat Molecular Test for Sexually Transmitted Infections

Image Credit: Adobe Stock Images/phurinee

Roche announced that it has received FDA 510(k) clearance and a Clinical Laboratory Improvement Amendments of 1988 (CLIA) waiver for the cobas liat sexually transmitted infection (STI) multiplex assay panels. The assays include panels for detecting chlamydia, gonorrhea, and Mycoplasma genitalium, allowing clinicians to diagnose and differentiate multiple STIs from a single sample. The tests are expected to be commercially available in the United States later this year.¹

“Rapid molecular point-of-care testing can revolutionize the clinical management of STIs in decentralized and community-based healthcare settings, enabling informed treatment strategies, better health outcomes for patients, and contain further spread by providing timely diagnosis.” said Matt Sause, CEO, Roche Diagnostics, in a press release.

According to Roche, over one million people contract an STI globally on a daily basis. The more common STIs can be asymptomatic, which creates a challenge in their diagnosis. STIs such as chlamydia and gonorrhea can lead to serious health complications, including pelvic inflammatory disease, urethritis, ectopic pregnancy, infertility, and an increased risk of HIV infection if left untreated.¹

According to the Centers for Disease Control and Prevention (CDC), there were over 2.4 million cases of syphilis, gonorrhea, and chlamydia diagnosed in 2023. These numbers include over 209,000 cases of syphilis, over 600,000 cases of gonorrhea, and over 1.6 million cases of chlamydia. However, the rate of STIs decreased 1.8% from 2022 to 2023 despite a 1% increase in total syphilis cases, primarily stemming from a 7.2% decrease in gonorrhea cases and stable chlamydia trends.

Also in 2023, an estimated 48.2% of chlamydia, gonorrhea, and syphilis cases were reported in adolescents and young adults between 15 and 24 years of age. In the same year, 32.4% of all cases of chlamydia, gonorrhea, and primary and secondary (P&S) syphilis occurred in non-Hispanic Black or African American people, despite only representing 12.6% of the United States population. The CDC noted that gay and bisexual men are disproportionally impacted by STIs, including gonorrhea and P&S syphilis.²

In November 2024, the Department of Health and Human Services (HHS) announced the STI National Strategic Plan, with the goal of preventing STIs while improving patient access to prevention, care, and treatment free from discrimination. The goals include:

1. Prevent new STIs.
2. Improve the health of people by reducing adverse outcomes of STIs.
3. Accelerate progress in STI research, technology, and innovation.
4. Reduce STI-related health disparities and health inequities.
5. Achieve integrated, coordinated efforts that address the STI epidemic.

The plan is also designed to support groups that HHS considers to suffer the greatest impact from STIs, including adolescents, young adults, men who have sex with other men, and pregnant women. The plan is also intended to support certain racial and ethnic minorities, such as Black, American Indian, Alaska Native, and Hispanic populations.³

“Individuals who are infected with an STI may not be aware of their infection but can transmit the infection to others and may go on to develop long term and potentially fatal outcomes including cancer, chronic pelvic pain, ectopic pregnancies, and infertility. STIs can also be transmitted vertically from mother to infant during pregnancy or at delivery with potential adverse consequences for the infant. Infection with one STI may also facilitate the transmission of other STIs, including HIV,” reported the World Health Organization.⁴

References

1. Roche receives FDA clearance with CLIA waiver for cobas® liat molecular tests to diagnose sexually transmitted infections at the point of care. Roche. January 21, 2025. Accessed January 22, 2025. https://www.roche.com/media/releases/med-cor-2025-01-22

2. National Overview of STIs in 2023. CDC. Accessed January 22, 2025. https://www.cdc.gov/sti-statistics/annual/summary.html

3. STI National Strategic Plan Overview. HHS. Accessed January 22, 2025. https://www.hhs.gov/programs/topic-sites/sexually-transmitted-infections/plan-overview/index.html#:~:text=Progress%20Indicators,available%2C%20sex%20of%20sex%20partners.

4. Global and regional STI estimates. WHO. Accessed January 22, 2025. https://www.who.int/data/gho/data/themes/topics/global-and-regional-sti-estimates