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