Hologic Aptima får CE-märkning för detektion och diagnos av zikavirus

Aptima Zika Virus Assay är nu CE-märkt i Europa för detektion och diagnos av zikavirus hos patienter som kan ha exponerats för zikavirus eller som uppvisar symtom på infektion. Aptima Zika Virus Assay är ett molekylärt diagnostiskt test som detekterar zika-RNA i humant serum, plasma och urin. Analysen används i Hologics Panther-system.

Hologic has announced that the Company's Aptima® Zika Virus diagnostic assay is now CE marked in Europe for the detection and diagnosis of the Zika virus in patients at risk of exposure to Zika or with signs and symptoms of the virus. The Aptima® Zika Virus assay is a molecular diagnostic test that identifies the presence of Zika RNA in human serum, plasma and urine specimens, that can be used up to 14 days following the onset of symptoms.

The Aptima® Zika Virus assay is the latest Hologic test designed to run on the Company’s Panther® system, a market-leading, integrated platform that fully automates all aspects of nucleic acid amplification testing. By reducing hands-on time, the Panther® system helps to minimize labor needs and the potential for manual errors.

"At Hologic, we are driven to provide solutions to some of society's most urgent unmet health needs,” said João Malagueira, VP Sales Diagnostics, International. “The development of the Aptima® Zika Virus assay and its launch in Europe is a reflection of how we live up to this commitment. While the number of cases of the Zika virus in Europe is currently low, our new, highly sensitive assay will help ensure accurate diagnoses and reduce subsequent risk of infection.”

To learn more about the Aptima® Zika Virus assay, please visit www.hologic.com/zika.

About Zika Virus
According to the World Health Organization, Zika virus is an emerging mosquito-borne virus that was first identified in rhesus monkeys in Uganda in 1947 and in humans in 1952. Outbreaks of Zika virus disease have been recorded in Africa, the Americas, Asia and the Pacific. Zika virus is primarily transmitted to people through the bite of an infected mosquito from the Aedes genus, mainly Aedes aegypti in tropical regions. This is the same mosquito that transmits dengue, chikungunya and yellow fever. Sexual transmission of the Zika virus is also possible. Other modes of transmission, such as blood transfusions, are being investigated.1 The WHO also states that there is scientific consensus that Zika virus is a cause of microcephaly and Guillain-Barré, a serious and sometimes fatal muscle-wasting disease syndrome. Links to other neurological complications are also being investigated.1

The risk of a Zika virus disease outbreak in the European Region is moderate to low.2 This is mainly because the mosquito that is known to be responsible for the outbreak in the Americas (Aedes aegypti) is not widely present in Europe, although it is established in limited areas, such as Madeira Island and the north-eastern Black Sea coast. To date in Europe, the Zika virus has only been found in travelers returning from countries affected by the virus.2

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

1. World Health Organization. Zika Fact Sheet. http://www.who.int/mediacentre/factsheets/zika/en/. Accessed on 24 January 2017
2. European Commission. Zika Virus. http://ec.europa.eu/health/zika_en. Accessed on 24 January 2017