Hologic Launches First Fully Automated, Sample-to-Result Molecular Assay for Mycoplasma genitalium Detection in Europe
-- The CE-marked Aptima® Mycoplasma genitalium Assay on the Panther® System Identifies a Prevalent, Often Misdiagnosed Sexually Transmitted Infection --

MARLBOROUGH, Mass., December 16, 2015 -- Hologic, Inc. (Nasdaq: HOLX) announced today the European launch of the CE-marked Aptima Mycoplasma genitalium assay, adding to the growing menu of molecular tests available on the fully automated Panther system.

 

“Until now, a fully automated, sample-to-result nucleic acid amplification test (NAAT) had not been available to detect M. genitalium, a common sexually transmitted infection (STI) that is frequently misdiagnosed,” said Claus Egstrand, Hologic Group President, International. “Now, clinicians and laboratories can test for this STI alone or from the same sample used for other STI testing.”

 

M. genitalium was originally isolated in 1980.1 Since then, many studies have explored the prevalence of the infection, which can be present in up to 6% of men and women visiting STD clinics.2 It is associated with urethritis in men and women, and with cervicitis and pelvic inflammatory disease in women.3 Data also supports a correlation between M. genitalium infection and increased HIV-1 infection and transmission.4 Until now, identifying this elusive pathogen has been difficult because of its symptomatic similarities to other STIs, and due to limitations associated with traditional diagnostic approaches.

 

Accurate identification of M. genitalium is essential for successful treatment, as the infection can become resistant to antibiotics used to treat similar STIs.4 The Aptima Mycoplasma genitalium assay on the Panther system allows healthcare providers to diagnose and more effectively treat this STI.

 

The Aptima Mycoplasma genitalium assay further expands the test menu available on the Panther system, joining assays for HCV, HIV-1, HBV, HPV, chlamydia, gonorrhea and trichomoniasis. The assay may be used to test multiple sample types, including vaginal swabs, urine, unisex swabs or ThinPrep® Pap test vials, and will soon be available for use with multitest swabs for male meatal samples.

 

The Aptima Mycoplasma genitalium assay, Aptima HCV Quant Dx assay, Aptima HIV-1 Quant Dx assay and Aptima HBV Quant assay are not available for sale in the United States.

 

About Hologic

 

Hologic, Inc. is a leading developer, manufacturer and supplier of premium diagnostic products, medical imaging systems and surgical products. The Company's core business units focus on diagnostics, breast health, GYN surgical, and skeletal health. With a unified suite of technologies and a robust research and development program, Hologic is dedicated to The Science of Sure. For more information on Hologic, visit www.hologic.com.

 

Hologic, The Science of Sure, Aptima, Panther, ThinPrep and associated logos are trademarks and/or registered trademarks of Hologic, Inc. and/or its subsidiaries in the United States and/or other countries.

 

Forward-Looking Statements

 

This news release may contain forward-looking information that involves risks and uncertainties, including statements about the use of the Hologic Aptima Mycoplasma genitalium assay and the Panther system. There can be no assurance that 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 guarantee that these products will be adopted by customers 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.

 

References: 1. Jensen JS. Mycoplasma genitalium: the aetiological agent of urethritis and other sexually transmitted diseases. J Eur Acad Dermatol Venereol. 2004;18(1):1-11. 2. Anagrius C, et al. Mycoplasma genitalium: prevalence, clinical significance, and transmission. Sex Transm Infect. 2005;81:458-62. doi:10.1136/sti.2004.012062. 3. Manhart LE, et al. Mycoplasma genitalium: Should We Treat and How? Clin Infect Dis. 2011;53(S3):S129-S142. doi:10.1093/cid/cir702. 4. Taylor-Robinson D, et al. Mycoplasma genitalium: from Chrysalis to Multicolored Butterfly. Clin Microbiol Rev. 2011;24(3):498-514. doi:10.1128/CMR.00006-11.

 

Contact:


Michael Watts
Vice President, Investor Relations and Corporate Communications
(858) 410-8588

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