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Gynecology and reproductive health

Diagnostic solutions to support gynecologic and reproductive health needs.


Caring encounter between a woman and her gynecologist

Making a difference for millions of women and their families worldwide

Committed to enhancing gynecology and reproductive health

A woman’s health includes a range of reproductive and female-specific needs that change over time depending on her age, exposure to external factors, and family planning interests.

Roche is making a significant investment in the areas of healthcare that are meaningful to women when it comes to maintaining wellness, and a healthy fertility and pregnancy journey.

Our advanced diagnostic solutions rely on innovative technologies to provide timely and relevant answers that help guide clinical care decisions for a patient. A woman’s care can be individualized, using information from the right test, at the right time to help avoid the potential for over- or under-treatment.

Knowing that our tests are extensively validated and provide medical value during a woman's life course is especially important from conception planning, neonatal screening, pregnancy and delivery, to menopause.

A range of gynecologic and reproductive challenges

Within the area of gynecology and reproductive health, there are various conditions that can impact the wellness of women.

Polycystic ovary syndrome (PCOS)

A condition impacting around 3.4% of women worldwide, PCOS is a hormonal disorder affecting ovulation1 and causing other symptoms such as missed or irregular menstrual periods, excess hair growth, acne, infertility, and weight gain, as well as additional health complications.2 PCOS has historically been difficult to diagnose; quantitative determination of anti-Mullerian Hormone in plasma or serum can help identify polycystic ovarian morphology to aid in a PCOS diagnosis. The biological and psychological effects of PCOS can be long-term, and impact physical and emotional well-being.2

Fertility

There are many different causes of infertility, and around one in six couples struggle with infertility worldwide.3 Infertility can be a significant burden on couples in many ways, from psychological stress to the financial strain of high out-of-pocket costs of treatment.4

Preeclampsia

One of the leading causes of fetal and maternal morbidity and mortality, preeclampsia affects up to 3-5% of pregnancies globally.5 Associated complications for mother or baby can lead to intensive care admissions, causing a serious burden on healthcare providers.6

Gestational diabetes

Temporarily triggered by pregnancy, gestational diabetes develops in 16.7% of all pregnancies.7 It usually resolves itself afterward, though for some women with gestational diabetes, it carries long-term implications as it increases the risk of developing type 2 diabetes later in life.7

Sexually transmitted infections (STIs)

Worldwide more than one million STIs are acquired every day. The majority of these infections can be asymptomatic, meaning they can go unnoticed for a long time.8 If left undetected and untreated, certain STIs have the potential to cause serious complications in women, such as infertility or risk to pregnancy or newborn babies during childbirth.8

Gynecologic Cancers

Cancers affecting the reproductive organs, such as ovarian, endometrial, and cervical, affect many women worldwide. Cervical cancer is the fourth most common cancer in women globally, with around 660,000 new cases seen in 2022.9

Women’s healthcare presents unique challenges

For too long, science has placed men in the forefront as the “default human”, leaving women overlooked and left behind. As a result, today, women are faced with inequities in treatment, care, and access to healthcare. Added to this, there are a number of specific challenges in gynecologic and reproductive care:

  • Polycystic ovary syndrome (PCOS): It can be difficult to diagnose because its symptoms have a variety of potential causes, such as uterine fibroids, pelvic inflammatory disease, or polyps. Since misdiagnosis is common, women may live with PCOS symptoms for years before they are properly diagnosed.10
  • Fertility: Though many factors can contribute to infertility, diminished ovarian reserve is one of the major causes.11 As couples are waiting longer to have children, this becomes an important factor, as the ovarian follicle pool declines with age.12,13,14,15 Ovarian reserve testing provides information about the remaining eggs and the number of fertile years a woman has left.12
  • Preeclampsia: There are many challenges associated with preeclampsia such as a lack of effective treatment options, the balancing of maternal and fetal risks, and the need for a reliable test to assess disease severity and progression, as well as requirements for specialized care.16,17,18,19
  • Non-invasive prenatal testing: Pregnant women are routinely offered screening for trisomies but conventional screening has limitations. One out of every four Down syndrome cases in pregnant women is missed by traditional screening,20 and invasive procedures such as amniocentesis are associated with a risk of miscarriage.20
  • Sexually transmitted infections (STIs): With STIs many people do not experience symptoms, and therefore do not seek diagnosis or treatment. Different anatomical sites can be associated with multiple STIs and therefore an open discussion of the patient’s sexual behavior and history is required for a full risk assessment.
  • Gynecologic cancers: Early detection of gynecologic cancers can be difficult as often there are no symptoms until they are at a more advanced stage.21 Despite advances that make it nearly 100% preventable, cervical cancer remains one of the deadliest cancers in women. Screening with an HPV test provides significantly better sensitivity to identify women at risk compared to more traditional pap cytology that often misses disease; studies have shown that almost one in three women diagnosed with cancer had a normal pap cytology result. HPV DNA testing technology also makes it possible for patients to self-collect their cervical screening sample, which has the potential to significantly lower obstacles to care that many women in underserved communities face.22,23

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Benefits of Roche diagnostic solutions for managing gynecology and reproductive health

Unique solutions from a trusted provider

As a leader in in-vitro diagnostics, Roche provides trusted and innovative solutions to help assess risk, identify disease and monitor patients, with over 75 million women tested globally in 2020.

We have specific solutions intended to meet the unique gynecologic and reproductive needs of women. In 2020 alone we supported:24

  • Fertility: More than 1 million women explored AMH/AMH Plus as an indication of ovarian reserve in the quest to potentially build a family.
  • Preeclampsia management: About 500,000 pregnant women were properly managed with preeclampsia ratio tests.
  • Noninvasive prenatal testing (NIPT): Over two million expectant mothers were given accurate information about their babies.

Disrupting the standard of care to improve health management²⁵

Our commitment to constant innovation has yielded a portfolio of female-specific tests that deliver highly accurate results to relieve uncertainty as well as support early and appropriate decisions.

  • Polycystic ovary syndrome (PCOS): In January 2024 Roche was awarded the CE mark for the Elecsys® anti-müllerian hormone (AMH) Plus immunoassay to be used in the identification of polycystic ovary morphology, as part of the diagnosis of Polycystic Ovary Syndrome (PCOS).26
  • Fertility: We provide clinical confidence in reliable assessment of ovarian reserve and prediction of response to controlled ovarian stimulation with our Elecsys® AMH Plus immunoassay.27
  • Preeclampsia: The measurement of the Elecsys® sFlt-1/PlGF ratio is a reliable tool that can aid in predicting which pregnant women with suspected preeclampsia will or will not develop the condition. With this additional information, healthcare providers can be more confident to send healthy women home safely and to focus care on patients more likely to develop preeclampsia.28
  • Gestational diabetes: Early intervention and accurate, regular monitoring through our Accu-Chek blood glucose meter in combination with the mySugr app can help to keep mother and baby healthy throughout pregnancy.29,30
  • NIPT: Roche’s Harmony test screens for trisomy 21, trisomy 18, and trisomy 13 with greater accuracy and reduction in false positives compared to conventional serum screening methods for common trisomies. It can be performed as early as 10 weeks of gestation.20
  • Gynecologic cancers: Our portfolio includes tools to help assess risk or diagnosis options for female reproductive organ cancers. For cervical cancer, HPV DNA detection is recommended by the WHO as the primary screening test to help achieve cervical cancer elimination.31 Our cervical cancer solutions include the cobas® HPV–the first FDA-approved, CE-marked, and WHO Prequalified HPV test for primary cervical screening, which is now also FDA-approved for patient self-collection. This solution gives healthcare providers important information about a patient's risk for disease to help inform next-step care decisions.

Supporting women’s health worldwide

At Roche we believe every woman should benefit from tailored and equitable healthcare. That is why we collaborate with partners to improve access and ensure Roche creates long-term impact for women and their families in key areas:

  • AMH Plus: We are collaborating closely with Ferring Pharmaceuticals to expand access for women facing infertility in China.
  • NIPT: We are expanding access by driving change in reimbursement schemes in 20+ countries to provide reliable answers for women.
  • Preeclampsia: We are continuing to work with medical associations for guideline adoption, and with countries for reimbursement.
  • Cervical cancer screening: Our partnerships are aimed at reducing barriers to care, to help ensure that HPV DNA tests reach all women, no matter where in the world they live.

Contact us

Do you have questions about our products or services? We’re here to help. Contact a Roche representative in your region.

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References

  1. Jabeen A et al. Polycystic Ovarian Syndrome: Prevalence, Predisposing Factors, and Awareness Among Adolescent and Young Girls of South India. Cureus. 2022 Aug 12; 14(8):e27943.
  2. World Health Organization. Polycystic ovary syndrome [Internet; cited 2024 June]. Available from: https://www.who.int/news-room/fact-sheets/detail/polycystic-ovary-syndrome
  3. European Society of Human Reproduction and Embryology [Internet; cited 2024 June] Available from: https://www.eshre.eu/Press-Room/Resources.aspx
  4. RESOLVE. Infertility FAQ. [Internet; cited 2024 June] Available from: https://resolve.org/infertility-101/infertility-faq/
  5. Verlohren S et al. An automated method for the determination of the sFlt-1/PIGF ratio in the assessment of preeclampsia. Am J Obstet Gynecol. 2010; 202 (161), e1-11.
  6. Khan B et al. Preeclampsia Incidence and Its Maternal and Neonatal Outcomes With Associated Risk Factors. Cureus. 2022 Nov; 14(11):e31143.
  7. International Diabetes Federation. Gestational diabetes [Internet; cited 2024 June] Available from: https://idf.org/about-diabetes/gestational-diabetes/
  8. World Health Organization. Sexually transmitted infections [Internet; cited 2024 June] Available from: https://www.who.int/news-room/fact-sheets/detail/sexually-transmitted-infections-(stis)
  9. World Health Organization. Cervical cancer [Internet; cited 2024 June] Available from: https://www.who.int/news-room/fact-sheets/detail/cervical-cancer
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  11. Kesharwani DK et al. Fertility with early reduction of ovarian reserve. Cureus. 2022 Oct; 14(10):e30326.
  12. Jirge PR. Ovarian reserve tests. J Hum Reprod Sci. 2011;4(3):108-113.
  13. Maheshwari A et al. Assessment of ovarian reserve—should we perform tests of ovarian reserve routinely? Hum Reprod. 2006;21(11):2729-2735.
  14. Grynnerup AG et al. Recent progress in the utility of anti-Müllerian hormone in female infertility. Curr Opin Obstet Gynecol. 2014;26(3):162-167.
  15. Wallace WH et al. Human ovarian reserve from conception to the menopause PLoS ONE. 2010;5(1):e8772.
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  20. Sillence KA et al. Non-Invasive Screening Tools for Down’s Syndrome: A Review. Diagnostics. 2013;3(2):291-314.
  21. CDC. About Genital HPV Infection [Internet; 2024 June]. Available from: https://www.cdc.gov/sti/about/about-genital-hpv-infection.html?CDC_AAref_Val=https://www.cdc.gov/std/hpv/stdfact-hpv.htm
  22. Leyden WA, et al. Cervical cancer in women with comprehensive health care access: attributable factors in the screening process. J Natl Cancer Inst 2005;97:675-83.
  23. Andrae B, et al. Screening-preventable cervical cancer risks: evidence from a nationwide audit in Sweden. J Natl Cancer Inst 2008;100:622-9.
  24. F. Hoffmann-La Roche Ltd. Data on file.
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  26. Pathology in Practice. Roche immunoassay gains CE mark to support diagnosis of polycystic ovary syndrome [Internet; cited 2024 June]. Available from: https://www.pathologyinpractice.com/story/43806/roche-immunoassay-gains-ce-mark-to-support-diagnosis-of-polycystic-ovary-syndrome
  27. F. Hoffmann-La Roche Ltd. Elecsys® AMH Plus (Anti-Müllerian Hormone) [Internet; cited 2024 June]. Available from: https://diagnostics.roche.com/gb/en/products/params/elecsys-amh-anti-mullerian-hormone.html
  28. Vatesh M et al. sFlt-1/PlGF ratio test for pre-eclampsia: an economic assessment for the UK. Ultrasound Obstet. Gynecol. 2016 Dec;48(6):765-771.
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  31. WHO report on cancer: setting priorities, investing wisely and providing care for all (2020) https://www.who.int/publications/i/item/who-report-on-cancer-setting-priorities-investingwisely-and-providing-care-for-all. Accessed March 2024.