A high prevalence of existing STIs and newer infections with ambiguous transmission rates are a threat to sexual health globally. 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.
Diagnostics are often the first line of defense. Roche knows this well, demonstrating its commitment by organizing a consortium of human immunodeficiency virus (HIV) experts to develop the first HIV viral-load test in 1992 and later launching the first nucleic acid test (NAT) test to differentiate and confirm diagnosis of HIV-1 and/or HIV-2 in 2021. Roche is committed to quality STI diagnostics and innovative STI testing approaches to transform previously life-altering infections into manageable conditions.
Chlamydia
With 129 million new infections per year, chlamydia trachomatis (CT) is one of the most common bacterial STIs worldwide.1 In the U.S., cases of chlamydia are highest among adolescents and young adults, which account for 57.7% of all reported cases.2
The majority of CT cases do not present with symptoms, making management of these bacterial infections a challenge. Undiagnosed and untreated, CT may result in complications that affect the urethra, cervix, uterus, and prostate. CT is also a known cause of tubal factor infertility.3
Roche introduced the first-ever FDA-cleared PCR test for CT in 1993. Since then, the assay has been continually developed, along with the respective analytical solutions—gaining significant advances in accuracy and the ability to test for multiple STIs on one platform with a single sample.
Enhanced diagnostic sensitivity, improved flexibility, and reduced human error due to automation, enables technicians to work more efficiently while empowering clinicians to make CT testing a more routine part of patient care.
Gonorrhea
Neisseria gonorrhoeae (NG) is among the most common STIs, with over 80 million new cases annually.4 Infection with NG may often have no symptoms, especially in women. While easily treatable, the U.S. saw the first cases of gonorrhea in 2023 that showed resistance or reduced response to five classes of antibiotics for gonorrhea.5 Accurate diagnosis and appropriate treatment are necessary for reducing cases of gonorrhea.
Roche has continued to improve NG testing through advances in automation and accuracy. Roche instruments and assays make it easier to deliver faster, more reliable, and more accurate results.
Advances in molecular diagnostic test design can now provide information on antibiotic susceptibility or resistance. These results support decision-making that drive Resistance Guided Therapy, helping to ensure that the appropriate treatment plan is created.
Syphilis
Syphilis rates have surged in the past few years, hitting a 70-year high in 2021.6 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.7
Hepatitis (B,C)
Viral hepatitis accounts for 1.34 million deaths globally—including liver cancer, acute cases, and cirrhosis—and exceeded the number of deaths caused by HIV infection, tuberculosis, or malaria in 2018. By 2040, deaths from chronic hepatitis are expected to exceed the combined mortality associated with HIV, tuberculosis, and malaria.8
HBV infections are severely underdiagnosed and not curable—as many as 95% of infants infected with HBV develop chronic infections. Meanwhile, HCV infections are usually asymptomatic, causing approximately 55-85% of cases to develop into chronic infections, leading to significant (and unnecessary) mortality. Despite these numbers, vaccines exist for HBV and HCV, and are curable with antiviral medicines which are effective for more than 95% of persons with hepatitis C infection.9,10
Roche has remained committed to the global fight against viral hepatitis and other infectious diseases through reliable screening solutions and will continue to serve as a trusted partner in building a sustainable healthcare system infrastructure in every region for disease prevention and management.
Human immunodeficiency virus (HIV)
HIV and AIDS continue to impact millions of people. To date, over 40 million people have died from AIDS-related illnesses since the start of the epidemic. In 2022, about 39 million people globally were living with HIV, with only 86% of individuals knowing they had the infection.11
The importance of HIV RNA screening, especially in detecting LEVI syndrome, a long-acting early viral inhibition, reinforces the importance of early detection.
An unrivaled investment in research and development demonstrates Roche’s dedication to innovation. Roche pioneered the dual-target approach for HIV-1 viral load monitoring and continuously works to ensure assays can stay ahead of their highly mutagenic targets.
Roche products enable laboratories and healthcare providers to identify the most critical HIV targets quickly and accurately while eliminating manual intervention and minimizing errors.
Human papillomavirus (HPV)
HPV is very common and most women will be exposed to it at some point in their lives. Most HPV infections go away on their own, without causing any problems. When an HPV infection persists over time, it can cause abnormal cellular changes that may lead to cervical pre-cancer or cancer.
Cervical cancer is primarily caused by HPV, and about 80% of men and women will have had an HPV infection by age 45. Regular screenings for HPV that can detect disease before progressing beyond the pre-cancer stage can lessen the chances of cervical cancer developing.12
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 Diagnostics is committed to eliminating cervical cancer and improving patient outcomes through earlier diagnosis, enabling clinicians to make timely treatment decisions.
Mycoplasma genitalium (Mgen), Herpes simplex virus (HSV), and Trichomonas vaginalis (TV)
Mgen, HSV, and TV may not attract as much attention as other STIs, but they are important.
Mgen is a complex bacterial infection that is most commonly transmitted through direct genital-genital contact. Although often asymptomatic, this STI can be responsible for causing cervicitis in females, and causes urethritis in males.
Herpes simplex virus type 1 (HSV-1) is found in 3.7 billion people worldwide under the age of 50, while herpes simplex virus type 2 (HSV-2) is found in over 491 million people, ages 15-49 worldwide.13
Transmission of HSV most often occurs without symptoms. HSV-1 is spread through oral-to-oral or oral-to-genital contact, while HSV-2 is primarily spread through sexual contact. Oral herpes (cold sores) is caused by HSV-1, while genital herpes can be caused by either HSV-1 or HSV-2.14 However, as the majority of these infections are asymptomatic or unrecognized—most patients with genital herpes may be undiagnosed, therefore patient management remains a challenge.13
With an estimated 156 million cases in 2020 and a 1.5-fold increased risk for HIV acquisition, TV is one of the most common STIs.15
While TV is a highly curable parasitic infection, 70% of people infected show no symptoms. This contributes to a significant amount of silent transmission between partners, increasing the prevalence of disease immensely.16
If left undiagnosed and untreated, TV can lead to urethritis and chronic prostatitis in males. Females may experience pelvic inflammatory disease (PID), preterm birth, and other adverse pregnancy outcomes. Additionally, there is increased risk for acquisition of HIV infection in both sexes if infected with TV.15,16
Roche has developed real-time PCR tests to detect these microorganisms and assist in patient diagnosis. TV and Mgen can be detected from the same specimen used for chlamydia and gonorrhea testing.
There are more than 1 million sexually transmitted infections (STIs) acquired every day worldwide,17 and diagnostic testing is often the first line of defense. The impact of quality diagnostics and innovative testing approaches has transformed previously life-altering infections into manageable conditions.18 However, gaps in testing and patient care are still a challenge for health systems to control the spread of STIs.
Many STIs have no symptoms and are highly transmissible. Some can not be treated easily while others have developed resistance to antibiotics.16 In worst-case scenarios, untreated STIs may cause complications, such as infertility, ectopic pregnancy, sepsis, pelvic inflammatory disease, meningitis, stroke, cranial nerve palsies or even death.19-24 Fortunately, most STIs can be easily detected, with symptoms treated and often cured.
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.
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:
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.
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.
References
