New CDC Guidelines Endorse Opt-Out Screening for Two of the Most Common Sexually Transmitted Infections (STIs), Recommend Nucleic Acid Testing for Mycoplasma Genitalium

Rhea-AI Summary

Hologic, Inc. (Nasdaq: HOLX) applauds the CDC's new guidelines endorsing opt-out screening for chlamydia and gonorrhea among adolescent and young adult women. This approach is expected to enhance screening rates, thereby reducing the burden of undiagnosed STIs, especially as rates are surging post-COVID-19. The CDC notes that nearly 26 million new STI cases occur yearly, with young individuals aged 15-24 being significantly affected. Hologic's testing products, including the Aptima Combo 2 Assay, are positioned to benefit from this guideline shift, aiding in early detection and treatment.

Positive

• CDC's endorsement of opt-out screening may significantly increase patient screening rates for chlamydia and gonorrhea.
• Hologic's Aptima Combo 2 Assay and other diagnostic products are well-suited to capitalize on new screening guidelines.

Negative

• None.

Hologic, Inc. (Nasdaq: HOLX) commends the decision by the United States Centers for Disease Control and Prevention (CDC) to endorse an updated approach to screening for Chlamydia trachomatis and Neisseria gonorrhoea, two of the most common sexually transmitted infections (STIs) in the country.¹ The guidelines state that providers may now consider opt-out screening, sometimes referred to as universal screening, for these infections in adolescent and young adult women during routine clinical care.² Studies support that opt-out STI testing can improve patient acceptance, result in cost savings, and substantially increase screening, especially among patients who do not disclose sexual behavior.^2-5

Historically, the CDC has recommended that healthcare providers screen all sexually active women under the age of 25, as well as high-risk populations, on an annual basis. Many healthcare providers, however, report a reluctance on the part of their patients to discuss their sexual activity and/or a frequent lack of trust in the transparency of those discussions.² In contrast, a universal screening strategy automatically notifies the patient that testing will be performed unless the patient declines, regardless of reported sexual activity.² A universal screening strategy does not eliminate the need for a patient-provider conversation about sexual health, but instead makes STI testing part of routine care, thereby removing barriers and associated stigma.

“Including opt-out screening for chlamydia and gonorrhea in the newly updated CDC guidelines represents significant recognition of the value of this strategy in reducing infections, especially among young women,” said Michelle Garsha, vice president of women’s health in Hologic’s Diagnostic Solutions Division. “Women bear most of the burden of undiagnosed and untreated sexually transmitted infections, and with STIs resurging in the U.S. as we move out of the COVID-19 pandemic, reducing barriers to screening is even more important.”

The CDC reports that there are 26 million new cases of STIs each year, with 50% occurring among adolescents and young adults ages 15-24 years old.⁶ In fact, the CDC noted that “reported rates of chlamydia and gonorrhea are highest among females during their adolescent and young adult years.”² Many STIs are asymptomatic, meaning that regular screening is often the only way to know a patient’s status. However, because the COVID-19 pandemic impacted routine clinical care including STI testing, there is the potential for even more missed asymptomatic cases in the current environment.^6-8 Left untreated in women, chlamydia infections can lead to the development of pelvic inflammatory disease (PID), ectopic pregnancy, tubal factor infertility, and the potential for neonatal complications.⁹ Gonorrhea infections have also been linked to PID and neonatal complications, as well as an increased risk of HIV infection.^9,10

“As a practicing OB-GYN, I know that some teens and young women feel uncomfortable talking about their sexual activity and may feel there is a stigma associated with screening for STIs,” said Alison Cowan, MD and medical director, Diagnostic Solutions at Hologic. “By screening all young women, we can help normalize and destigmatize testing for STIs, allowing us to better serve our patients by identifying and treating more infections before they lead to serious complications like infertility.”

For the first time, CDC guidelines also defined specific populations (men with recurrent urethritis and women with recurrent cervicitis) to be tested for Mycoplasma genitalium and recommended nucleic-acid amplification testing (NAAT) for detection. The 2015 CDC guidelines included M. genitalium as an emerging issue, but no FDA-cleared NAATs were available at that time¹¹. Hologic was first to market in 2019 with a NAAT for M. genitalium, and Hologic’s Aptima^® Mycoplasma genitalium Assay is specifically noted in the current guidelines¹. Before the introduction of NAAT testing for M. genitalium, diagnosis could only be suspected in men with recurrent urethritis and women with recurrent cervicitis because the bacterium cannot be grown effectively in culture. Anitibiotic resistance is a pressing issue with M. genitalium infections, with one study led by Hologic scientists demonstrating that approximately half the women who tested positive were infected with an antibiotic-resistant strain¹². No FDA-cleared M. genitalium tests are available in the U.S. that detect antibiotic resistance, although Hologic is working to develop one.

Hologic developed and markets the widely used Aptima Combo^® 2 Assay for detecting chlamydia and gonorrhea, as well as the Aptima^® Multitest Swab Specimen Collection Kit, which can be which can be used to collect samples for detection of up to seven disease states and infections using Hologic’s suite of Aptima sexual health assays, including Bacterial vaginosis, Candida species, Candida glabrata, trichomoniasis, chlamydia, gonorrhea and Mycoplasma genitalium. For more information on Hologic’s sexual health and other diagnostic assays, visit https://www.hologic.com/hologic-products/diagnostic-solutions.

About Hologic

Hologic, Inc. is an innovative medical technology company primarily focused on improving women’s health and well-being through early detection and treatment. For more information on Hologic, visit www.hologic.com.

Hologic Forward-Looking Statements

This press release may contain forward-looking information that involves risks and uncertainties, including statements about the use of Hologic’s diagnostic products. There can be no assurance these products will achieve the benefits described herein or that such benefits will be replicated in any particular manner with respect to an individual patient. The actual effect of the use of the products can only be determined on a case-by-case basis depending on the particular circumstances and patient in question. In addition, there can be no assurance that these products will be commercially successful or achieve any expected level of sales. Hologic expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any such statements presented herein to reflect any change in expectations or any change in events, conditions or circumstances on which any such statements are based.

Hologic, The Science of Sure, Aptima, and Aptima Combo 2 are registered trademarks of Hologic, Inc. in the United States and/or other countries.

References

1. U.S. Centers for Disease Control and Prevention. STD Statistics. https://www.cdc.gov/std/statistics/2019/default.htm. Accessed July 26, 2021.
2. Workowski KA, Bachmann LH, Chan PA, et al. Sexually Transmitted Infections Treatment Guidelines, 2021. MMWR Recomm Rep 2021;70(No. RR-4):1–187. DOI: http://dx.doi.org/10.15585/mmwr.rr7004a1
3. DiClemente RJ, Sales JM, Danner F, Crosby RA. Association between sexually transmitted diseases and young adults’ self-reported abstinence. Pediatrics 2011;127:20813. https://pediatrics.aappublications.org/content/127/2/208
4. Owusu-Edusei K Jr, Hoover KW, Gift TL. Cost-effectiveness of opt-out chlamydia testing for high-risk young women in the US. Am J Prev Med. 2016;51(2):216?224; doi: 10.1016/j.amepre.2016.01.007.
5. Montoy JC, Dow WH, Kaplan BC. Patient choice in opt-in, active choice, and opt-out HIV screening: randomized clinical trial. BMJ. 2016; 352:h6895. doi.org/10.1136/bmj.h6895
6. Kaufman HW, Gift TL, Kreisel K, Niles JK, Alagia DP. Chlamydia and Gonorrhea: Shifting Age-Based Positivity Among Young Females, 2010-2017. Am J Prev Med. 2020;59(5):697-703. doi:10.1016/j.amepre.2020.05.023
7. U.S. Centers for Disease Control and Prevention. Trends in STD case reports during the U.S. COVID-19 pandemic, January-December 2020. https://www.cdc.gov/nchhstp/newsroom/2021/2020-std-trend-report.html. Accessed July 26, 2021.
8. Casey N. Pinto, Justin K. Niles, Harvey W. Kaufman, Elizabeth M. Marlowe, Damian P. Alagia, Guangqing Chi, Barbara Van Der Pol, Impact of the COVID-19 Pandemic on Chlamydia and Gonorrhea Screening in the U.S.,American Journal of Preventive Medicine, 2021. https://doi.org/10.1016/j.amepre.2021.03.009.
9. Swain GR, McDonald RA, Pfister JR, Gradus MS, Sedmak GV, Singh A. Decision analysis: point-of-care Chlamydia testing vs. laboratory-based methods. Clin Med Res. 2004;2(1):29-35. doi:10.3121/cmr.2.1.29
10. U.S. Department of Health and Human Services. 2020. Sexually Transmitted Infections National Strategic Plan for the United States: 2021–2025. Washington, DC. www.hhs.gov/STI.
11. https://www.cdc.gov/std/tg2015/emerging.htm#myco. Accessed July 23, 2021.
12. Getman, D, Jiang A., O’Donnell, M and Cohen, S. Mycoplasma genitalium Prevalence, Coinfection, and Macrolide Antibiotic Resistance Frequency in a Multicenter Clinical Study Cohort in the United States. J. of Clinical Microbiology. 2016. https://journals.asm.org/doi/10.1128/jcm.01053-16. Accessed July 23, 2021.

Source: Hologic, Inc.

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FAQ

What recent guideline changes has the CDC implemented regarding STI screening for women?

The CDC now endorses opt-out screening for chlamydia and gonorrhea for adolescent and young adult women, which is expected to improve screening rates.

How does the CDC's new approach to STI screening impact Hologic (HOLX)?

The updated guidelines may drive increased demand for Hologic's diagnostic products, especially the Aptima Combo 2 Assay, as more patients are screened.

What are the statistics related to STIs in the United States as reported by the CDC?

The CDC reports approximately 26 million new STI cases annually, with about 50% occurring in adolescents and young adults aged 15-24.

What is the significance of opt-out screening for chlamydia and gonorrhea?

Opt-out screening normalizes STI testing, helping to overcome barriers and stigma, thereby leading to more infections being detected and treated early.