New CDC Guidelines Endorse Opt-Out Screening for Two of the Most Common Sexually Transmitted Infections (STIs), Recommend Nucleic Acid Testing for Mycoplasma Genitalium
July 26 2021 - 8:02AM
Business Wire
With STIs reaching a new high for the sixth
consecutive year, a more inclusive screening approach is considered
for chlamydia and gonorrhea in women under 25
First CDC guidelines to recommend testing
specific populations for Mycoplasma genitalium, which was
previously listed as an emerging issue
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
- U.S. Centers for Disease Control and Prevention. STD
Statistics. https://www.cdc.gov/std/statistics/2019/default.htm.
Accessed July 26, 2021.
- 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
- 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
- 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.
- 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
- 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
- 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.
- 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.
- 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
- 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.
- https://www.cdc.gov/std/tg2015/emerging.htm#myco. Accessed July
23, 2021.
- 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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