Sexual health and sexually transmitted infections (STIs)

Sexually transmitted infections are on the rise. Access to screening and diagnostic testing can be the first line of defense. Diagnostics and innovative testing can make STIs manageable conditions.

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Illuminating the importance of diagnostics for sexual health

Rising concerns

STIs on the rise

Sexual health is threatened by higher prevalence of existing STIs and newer infections with ambiguous transmission rates. It’s never been more important to provide accurate testing information quickly to healthcare providers and their patients for assessing risk and helping to diagnose, monitor, and treat patients.

As tests are brought closer to patients in a doctor’s office or emergency room, there’s greater opportunity to get results faster and provide treatment before the patient leaves sites of care. Increasingly, panel tests are being developed that can test for several different infections with one sample. For example, Roche’s own cobas® liat has developed STI panels that can test for chlamydia and gonorrhea (CT/NG) or chlamydia, gonorrhea, and Mycoplasma genitalium (CT/NG/MG) at the same time with one sample.

Chlamydia

Chlamydia, caused by Chlamydia trachomatis, historically accounts for the largest proportion of reported STIs in the United States. It often doesn't cause symptoms and is easily spread, so people may not know that they have it. However, even without symptoms of infection, it can have serious health impacts such as infertility and an increased risk of contracting or transmitting other infections like HIV.^2,4 Cases of chlamydia are highest among adolescents and young adults, who account for more than half of all reported cases.⁸ Roche has created tests to rapidly detect chlamydia both in laboratory settings and in near-patient settings such as urgent care clinics. Also, Roche has developed a dual target test with an internal control to provide confidence in test results.

Gonorrhea

From 2009 to 2019, gonorrhea rates have grown by 92%.⁸ Infection with Neisseria gonorrhea may often have no symptoms, but like chlamydia, have serious implications if untreated. Treatment of gonorrhea can be complicated due to the rise in antibiotic resistance. While good treatments currently exist, there are reports of infections that are becoming resistant to even the first line of infection treatment.⁹ Accurate diagnosis and appropriate treatment are necessary for reducing cases of gonorrhea.Roche has created tests to rapidly detect chlamydia both in laboratory settings and in near-patient settings such as urgent care clinic. Roche’s has created a dual-target test with an internal control to provide confidence in test results. Also, Roche has created tests to rapidly detect chlamydia both in laboratory settings and in near-patient settings such as urgent care clinics.

Mycoplasma genitalium (Mgen)

Mycoplasma genitalium (Mgen), is another common STI which was first identified 40 years ago and has been linked to infertility. While this infection is treatable, there have been reports of increasing drug resistance. Testing for Mgen is important because it can have similar symptoms to STIs, but it is treated with a different medication, so accurate diagnosis is vital to ensure effective treatment.

Trichomonas vaginalis (TV)

Trichomonos vaginalis (TV) infection is commonly asymptomatic, but like the other infections, can lead to serious health consequences when left untreated. TV is one of the most common non-viral sexually transmitted infections worldwide.Roche has developed a high-throughput, laboratory-based test to accurately detect TV.

Roche has developed real-time PCR tests to detect all of these microorganisms and assist in patient diagnosis. T. vaginalis and M. genitalium can be detected from the same specimen used for chlamydia and gonorrhea testing.

Syphilis

Syphilis has surged in the past few years, hitting the highest incidence since the 1950s.¹⁰ The disease has been discovered at a much higher rate in newborns and, in some cases, resulted in stillbirths and infant deaths. Syphilis is easily treatable, especially when diagnosed in the earlier stages of infection.⁹

HPV

Cervical cancer is primarily caused by the human papillomavirus, and about 80% of men and women will have had an HPV infection by age 45. While not all HPV infections lead to cancer, regular screenings for HPV can detect infection in the pre-cancer stage. Early detection of HPV infection can lessen the chances of cervical cancer developing.

Roche has been using advances in science to develop ways to more meaningfully answer clinician and patient questions earlier in the progression of cervical cancer, assisting them in making treatment decisions. Roche is also looking for other ways to reach patients and has recently gained FDA approval on HPV self-collection in a healthcare setting that can help overcome barriers some may have with traditional testing. Roche Diagnostics is committed to eliminating cervical cancer and improving patient outcomes through earlier diagnosis, which can lead to earlier treatment.

To learn more about other related infections, such as HIV and Hepitatis, please see our Virology page.

Featured products

IVD

cobas^® CT/NG, Qualitative nucleic acid test for use on the cobas^® 5800/6800/8800 systems

cobas® CT/NG for use on the cobas® 5800/6800/8800 Systems is an automated, qualitative in vitro nucleic acid diagnostic test, that utilizes real-time polymerase chain reaction (PCR), for the direct detection of Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (NG) DNA in male and female urine, clinician-instructed self-collected vaginal swab specimens (collected in a clinical setting), and clinician-collected vaginal swab specimens, endocervical swab specimens, oropharyngeal (throat) swab specimens and anorectal swab specimens all collected in cobas® PCR Media (Roche Molecular Systems, Inc.), and cervical specimens collected in PreservCyt® Solution. This test is intended as an aid in the diagnosis of chlamydial and gonococcal disease in both symptomatic and asymptomatic individuals.

IVD

cobas^® HSV 1 and 2 Test, for use on the cobas^® 4800 system

The cobas® HSV 1 and 2 Test on the cobas® 4800 system is an automated, qualitative in vitro diagnostic test, that utilizes real-time polymerase chain reaction (PCR), for the direct detection and differentiation of Herpes simplex virus 1 and 2 (HSV-1 and HSV-2) DNA in clinician-collected, external anogenital lesion specimens from symptomatic male and female patients. The cobas® HSV 1 and 2 Test is intended for use as an aid in diagnosis of anogenital HSV-1 and HSV-2 infections in symptomatic patients.Warning: The cobas® HSV 1 and 2 Test is not FDA cleared for use with cerebrospinal fluid (CSF) and is not intended to be used for prenatal screening or for individuals under the age of 18 years.

IVD

Elecsys^® HIV Duo

Immunoassay for the qualitative determination of HIV p24 antigen and antibodies to HIV.

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Benefits of Roche diagnostic solutions for managing STIs

Comprehensive value

A pioneer in reliable and comprehensive STI diagnostics

For some infections, reliably identifying the cause poses a notable challenge. At Roche Diagnostics, we believe that high-throughput systems and fully automated workflows are helping to accelerate time-to-diagnosis, but this is just part of the equation. From screening and diagnosis to follow-up monitoring, people, laboratories, and point-of-care settings benefit from Roche’s comprehensive portfolio of infectious disease diagnostic solutions.

Optimizing nucleic acid amplification testing (NAAT) techniques, like polymerase chain reaction (PCR) testing, has allowed test developers to push the boundaries of traditional diagnostics. Increasingly sophisticated assays with better sensitivity, specificity, and efficiency of scale have the potential to bring an entire paradigm shift in disease management, as seen in HPV screening for cervical cancer prevention.²⁵

At Roche Diagnostics, we’ve created simultaneous testing for multiple targets to enhance the reliability of testing. Compensating for the possibility of genotype variations, mutations and mismatches has increased the probability of detection for infections like HIV, syphilis, hepatitis C virus (HCV), and chlamydia, and can help to preemptively identify cases of co-infection. Similarly, advances in testing strategies—like running multiple tests on a single patient sample in the same run—helps to decrease the burden on laboratory staff. By improving the use of precious personnel resources, laboratories can flexibly meet surges in demand while maximizing the value they provide across the health system.

For markets where populations are spread throughout sprawling remote areas, Roche Diagnostics is finding new ways of collecting samples and communicating results, with the hope to revolutionize disease management—from initial diagnosis and monitoring viral load, to promoting patient follow-up.

Accessibility

A leader in accessible STI diagnostics

As an example of Roche’s commitment to accessible STI diagnostics, we have been at the forefront of efforts to reliably diagnose and treat HIV infection since 1986. As the leading provider of HIV early infant diagnosis and viral load testing, Roche has a social responsibility to provide care where access is limited, especially in countries hardest hit by the disease.

To address this, Roche has launched and supported solutions which expand diagnostics to where they are needed most. Some example include:

Early infant diagnosis
Dried blood spot collection
Viral load testing
Mobile health solution

We collaborate with partner organizations, governments and relief organizations worldwide to improve access to highly sensitive diagnostics assays that help people who need them around the world.

By working together with international agencies, non-governmental organizations and governments at the global, regional and local level, we take a holistic and collaborative approach to improve health system diagnostic capacity.

Our range of solutions includes disease awareness and education programs, healthcare worker training, lab efficiency consulting, and digital solutions. Through our partnerships we can help create scalable and sustainable solutions for laboratories, healthcare professionals, and patients. Our aim is to support international agencies and countries with a long term goal of establishing sustainable national programs.

Global surveillance

A legacy in global surveillance

In 1998, at the International AIDS Conference in Geneva, Roche inaugurated the Global Surveillance Program. Initially designed solely to monitor changes in the HIV-1 genomic sequence, the program and its database have since expanded to cover the pathogen targets of many Roche diagnostic assays and also to include bioinformatics pipelines to assess the predicted impact of sequence variation on assay performance.

The Program’s efforts and many achievements have played a monumental role in helping to maintain, and improve, the reliability of molecular assays. Innumerable researchers, physicians, and patients around the world have benefited as a result.

Collaborations with researchers worldwide to understand performance of approved tests in commercially operating facilities further enhances Roche’s understanding to optimize and improve our bioinformatics tools using data generated in the field.

The Global Surveillance Program is an integral part of Roche Molecular Diagnostics product development at multiple points in the process, including research and development, regulatory submission, and post-launch support. It is a powerful example of Roche’s unique and robust commitment to the researchers, physicians, and patients working to fight disease and maintain health around the world. As the demands of their mission are constantly evolving, so are we. We are committed not only to keep up with the pace, but also to lead.

STIs on the rise

Sexual health is threatened by higher prevalence of existing STIs and newer infections with ambiguous transmission rates. It’s never been more important to provide accurate testing information quickly to doctors and their patients for assessing risk and helping to diagnose, monitor and treat patients.