FDA Clearance of Aptima BV and Aptima CV/TV Molecular Assays Ushers in New Era of Comprehensive and Objective Diagnostic Testing for Vaginitis

–Improved accuracy in identifying bacterial vaginosis (BV),
vulvovaginal candidiasis (Candida vaginitis, CV) and trichomoniasis
(Trichomonas vaginalis, TV) will enable more targeted treatment for
women–

MARLBOROUGH, Mass.–(BUSINESS WIRE)–lt;a href=”https://twitter.com/hashtag/Aptima?src=hash” target=”_blank”gt;#Aptimalt;/agt;–Hologic, Inc. (Nasdaq: HOLX) announced today that the FDA has granted
clearance for its new Aptima® BV and Aptima® CV/TV
assays, which provide an accurate and objective method for diagnosing
vaginitis, a very common and complex health issue affecting millions of
women each year.

About 90 percent of vaginitis is caused by bacterial vaginosis (BV),
vulvovaginal candidiasis (Candida vaginitis, CV, also commonly
known as yeast infections), or Trichomonas vaginalis (TV)
infections, either individually or in combination.1,2 In
fact, BV is the most common vaginal infection in the United States,
affecting an estimated 21 million women ages 14 to 49 years old.3
Diagnosis can be especially complicated due to the prevalence of
co-infections, as approximately 20 to 30 percent of women with BV are
co-infected with Candida species.1 Traditional methods
for diagnosing vaginitis (including microscopy, pH determination and
Nugent scoring) are highly subjective, leading to misdiagnosis and
ineffective treatment.1,2 When diagnosed using traditional
methods and treated based on those subjective results, more than 50
percent of women with vaginitis experience recurring symptoms.1

“Vaginitis is one of the most common reasons women visit a healthcare
provider, and Hologic’s new molecular assays have the potential to
transform how these infections are diagnosed in that very first
appointment,” says Dr. Edward Evantash, an OB-GYN who is medical
director and vice president of medical affairs at Hologic. “The improved
sensitivity and specificity of Hologic’s molecular assays over
traditional methods in determining the underlying cause of vaginitis not
only means identifying the right infection, but enabling the right
treatment and, in turn, reducing the potential for recurrent or
persistent infections.”

Unfortunately, many women self-diagnose and self-treat before visiting a
healthcare provider, assuming that abnormal vaginal discharge, itching
or irritation is due to a simple yeast infection. When BV or TV are left
untreated or not properly treated, these infections can put women at
risk for a wide variety of complications, including an increased chance
of getting a sexually transmitted infection (STI) such as chlamydia or
HIV, pelvic inflammatory disease, and pregnancy-related risks including
premature delivery, low birth weight and infertility.1,2

Hologic’s commitment to women’s health and well-being

Building on Hologic’s commitment to women’s health, the Company’s
Diagnostic Solutions division continues to make advancements in
molecular testing. It provides state-of-the-art molecular testing for
cervical cancer and the detection of most STIs, including chlamydia,
gonorrhea, Mycoplasma genitalium, trichomoniasis, HIV, HPV and
hepatitis B and C. “With these latest FDA clearances, we now have 16
assays in the U.S. that help advance women’s health and more,” said Tom
West, Division President, Diagnostic Solutions. “This suite of new
molecular tests for vaginitis is a prime example of Hologic’s investment
in technologies that introduce greater accuracy – and peace of mind –
for laboratorians, healthcare providers and ultimately the women we
serve.”

About vaginitis, a very common and complex health issue

Vaginitis is a general term for disorders of the vagina caused by
infection, inflammation or changes in the normal vaginal flora. Symptoms
of vaginitis can vary but may include vaginal discharge, odor and
itching; pain during urination or sexual intercourse; or spotting or
bleeding, among others. The three causes of vaginitis that Hologic’s new
FDA-cleared assays address – BV, yeast infections and TV – are
similar and often misdiagnosed, which can lead to improper treatment.
However, each cause of vaginitis has its own characteristics,
consequences and treatment recommendations.

  • Bacterial Vaginosis (BV) – BV is the most common vaginal
    infection and occurs when there is an imbalance of naturally occurring
    bacteria in the vagina, and women typically experience an
    uncomfortable vaginal discharge.1 Left untreated, BV can
    increase a woman’s chance of miscarriage, preterm birth and getting an
    STI, such as chlamydia, gonorrhea, herpes simplex virus (HSV), or HIV.1
  • Vulvovaginal Candidiasis (Candida vaginitis, CV)
    – Commonly known as a yeast infection, vulvovaginal candidiasis is
    a result of an overgrowth of fungal organisms, usually Candida
    albicans
    . Yeast infections caused by other Candida species,
    such as Candida glabrata, can be more difficult to treat, and
    may require more aggressive therapies.2 The Aptima CV/TV
    assay differentiates between these specific Candida species,
    which better informs appropriate antifungal treatment.
  • Trichomonas vaginalis (TV) – Sometimes referred
    to as “trich,” TV is the second most common STI in the U.S. Left
    untreated, TV infection can lead to premature labor and low birth
    weight babies.2 TV is also associated with an increased
    risk of HIV acquisition and prolonged HPV infection.2 The
    CDC recommends testing for TV in all women seeking treatment for
    vaginal discharge. The CDC also recommends the use of nucleic acid
    amplification tests (NAAT) for detecting TV.4 Because TV is
    an STI, a woman’s partner also needs to be tested and treated to
    prevent reinfection.

The Aptima® Multitest Swab Specimen Collection Kit enables
healthcare providers to test up to seven disease states and infections,
including BV, Candida species, Candida glabrata,
trichomoniasis, chlamydia, gonorrhea and Mycoplasma genitalium.
The Aptima “orange vial” and Aptima assays are run on Hologic’s Panther®
system. Hologic’s Panther and Panther Fusion® systems now
offer 16 FDA-cleared assays that detect more than 20 pathogens, making
them the only high-throughput molecular diagnostic platforms in the U.S.
to combine comprehensive sexual health, cervical health, viral load,
respiratory testing and open channel functionality on a fully automated
system.

For more information on the Aptima assays, visit www.hologic.com.

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, Panther and Panther Fusion are
registered trademarks of Hologic, Inc. in the United States and/or other
countries.

SOURCE: Hologic, Inc.

_________________________

1 Hologic. Aptima BV Assay Package Insert. https://www.hologic.com/package-inserts/diagnostic-products?portfolio=136

2 Hologic. Aptima CV/TV Assay Package Insert. https://www.hologic.com/package-inserts/diagnostic-products?portfolio=136

3 Koumans EH, Sternberg M, Bruce C, McQuillan G, Kendrick J,
Sutton M, Markowitz LE. The prevalence of bacterial vaginosis in the
United States, 2001-2004; associations with symptoms, sexual behaviors,
and reproductive health. External. Sex Transm Dis. 2007
Nov;34(11):864-9

4 Centers for Disease Control and Prevention. 2015 Sexually
Transmitted Diseases Treatment Guidelines. https://www.cdc.gov/std/tg2015/trichomoniasis.htm.
Updated June 4, 2015. Accessed May 13, 2019.

Contacts

Media Contact:
Jane Mazur
508.263.8764 (direct)
585.355.5978
(mobile)
[email protected]

Investor Contact:
Michael Watts
858.410.8588
[email protected]

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