CE-märkning för Hologics molekylära analyser för säker diagnostisering av vaginoser och vaginiter

Hologic lanserar Aptima BV och Aptima CV/TV för säker diagnostisering av vanligt förekommande, men komplexa underlivsinfektioner som drabbar många kvinnor. Det gäller bakteriell vaginos respektive candidavaginit (Candida vaginitis) och trikomonasinfektion (Trichomonas vaginalis). En korrekt diagnos krävs för att kunna ge rätt behandling, men traditionella metoder som mikroskopering, snifftest och pH-mätning förslår inte alltid.

Nu erhåller Hologic CE-märkning för Aptima BV och Aptima CV/TV, molekylära tester med signifikant förbättrad sensitivitet och specificitet jämfört med äldre tekniker.

Hologic, Inc. has launched its new Aptima^® BV and Aptima^® CV/TV assays for IVD use on the Panther^®system in Europe. These CE-marked assays provide an accurate and objective method for diagnosing vaginitis, a common and complex health issue affecting millions of women each year.¹

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.² In fact, BV is the most frequent cause of abnormal vaginal discharge in women of childbearing age.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.⁴ Traditional methods for diagnosing vaginitis (including microscopy, pH determination and Nugent scoring) are highly subjective, leading to misdiagnosis and ineffective treatment.⁵ When diagnosed using traditional methods and treated based on those subjective results, more than 50 percent of women with vaginitis experience recurring symptoms.⁶

“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, vice president of global medical affairs (Diagnostics), 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.”

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

“The availability of these new assays means we are now able to offer approximately 20 assays on the Panther system in the U.K. and Netherlands, enabling laboratories in these countries to consolidate their molecular testing onto one molecular diagnostic platform,” said Jan Verstreken, Hologic’s President of EMEA and Canada.

“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,” said Kevin Thornal, Hologic’s Division President, Diagnostic Solutions.

Samples to be tested with the Aptima BV and Aptima CV/TV assays can be collected using the Aptima^® Multitest Swab Specimen Collection Kit, which enables healthcare providers to test up to seven disease states and infections, including chlamydia, gonorrhoea 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 20 CE-IVD assays, making them the only high-throughput molecular diagnostic platforms to combine comprehensive sexual health, vaginal 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.

Media Contact:
Jane Mazur
+1 508.263.8764 (direct)
+1 585.355.5978 (mobile)jane.mazur@hologic.com

_________________________

¹Kent HL. Epidemiology of Vaginitis. Am J Obstet Gynecol. 1991;165(4, part 2):1168-1176.

²ACOG Practice Bulletin No. 72. Clinical management guidelines for obstetrician-gynecologists: Vaginitis. Obstet Gynecol 2006 May; 107(5): 1195-1206.

³J.S.Jensen 2018 European (IUSTI/WHO) Guideline on the Management of Vaginal Discharge https://www.iusti.org/regions/Europe/pdf/2018/IUSTIvaginalDischargeGuidelines2018.pdf. Accessed September 2019.

⁴Sobel, Jack D. Mixed Vaginitis—More Than Coinfection and With Therapeutic Implications. Current Infectious Disease Reports. 2013; 15:104–108.

⁵ Anderson MR, Klink K and Cohrssen A. Evaluation of Vaginal Complaints. JAMA. 2004;291(11):1368–1379. doi:10.1001/jama.291.11.1368.

⁶ Bradshaw, Catriona S. High Recurrence Rates of Bacterial Vaginosis over the Course of 12 Months after Oral Metronidazole Therapy and Factors Associated with Recurrence. Journal of Infectious Disease. 2006 June; Volume 193, Issue 11: 1478–1486.