Lab Matters Summer 2017 | Page 32

industry matters

By Tom West, division president, Diagnostic Solutions, Hologic

regularly to run our women’ s health menu, it was quite simple to bring the Aptima ® Zika Virus Assay on board.”

The Aptima ® Zika Virus assay is designed to be used in individuals meeting CDC’ s Zika virus clinical criteria( e. g., clinical signs and symptoms associated with Zika virus infection) and / or CDC Zika virus epidemiological criteria( e. g., history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiologic criteria for which Zika virus testing may be indicated), by laboratories in the United States that are certified under the Clinical Laboratory Improvement Amendments of 1988( CLIA), 42 U. S. C. § 263a, to perform high-complexity tests, or by similarly qualified non-US laboratories.

Zika virus

Although the US Centers for Disease Control and Prevention( CDC) lifted its cautionary designation for parts of Texas and Florida, 1 the agency, as of June 2017, continued to provide guidance for health departments and healthcare providers who care for people with potential exposure, particularly pregnant women or those trying to conceive. 2 It is therefore important for public health laboratories throughout the country to maintain the capability to diagnose Zika infection.

“ Early in 2016, we were approached by the US Food and Drug Administration( FDA) about developing a molecular diagnostic assay, and we were able to quickly rally our R & D and product development teams to develop the test in a matter of months,” said Tom West, division president, Diagnostics Solutions at Hologic.“ This rapid turnaround time reflects our commitment to developing cutting-edge diagnostics that provide solutions for urgent unmet needs."

Hologic’ s molecular test, the Aptima ® Zika Virus Assay, received an Emergency

Use Authorization from FDA in June 2016 and a CE-IVD label in February 2017. 3, 4 The assay is commercially available in the United States and Europe.

The Aptima ® Zika Virus assay is a molecular diagnostic tool for the qualitative detection of RNA from Zika virus in human serum, urine and plasma specimens. 3, 4, 5 The assay runs on the Hologic Panther ® system, a market-leading, integrated platform that fully automates all aspects of nucleic acid amplification testing. The Panther system substantially reduces hands-on time for laboratories, minimizing the labor required and the potential for manual errors.

“ Molecular tests are the optimum method for rapid detection of infectious agents, from HIV to respiratory pathogens to Zika virus,” said Anna Liza Manlutac, supervising PH microbiologist at the Public Health Services-Laboratory, County of San Diego Health & Human Services Agency.“ Because our laboratory has been using the Panther ® system

According to CDC, Zika virus can be transmitted through sexual contact, mosquito bites and from an infected woman to fetus, with transmission through blood transfusion likely. 6 Infection during pregnancy can cause the severe birth defect microcephaly and is also linked to other problems, such as miscarriage, stillbirth and additional birth defects. 6 CDC maintains cautionary travel recommendations for a number of countries across the globe where Zika has been reported, including a reference map to help travelers and their healthcare providers ascertain risks and which diagnostic measures may be indicated. 7 n

Hologic is a Diamond Level Sustaining Member of APHL.

References:

1 https:// www. cdc. gov / media / releases / 2017 / s0602-zika-guidance. html

2 https:// www. cdc. gov / zika / geo / post-cautionary-guidance. html

3 http:// investors. hologic. com / news? item = 603

4 http:// investors. hologic. com / news? item = 641

5 http:// investors. hologic. com / 2016-09-08-FDA-Expands- Emergency-Use-Authorization-for-Hologics-Aptima-Zika-Virus- Assay-to-Include-Use-with-Urine-Samples

6 https:// www. cdc. gov / zika / about / overview. html

7 https:// www. cdc. gov / zika / pregnancy / protect-yourself. html