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Hologic, Inc., entered into a $4.1 million agreement with the U.S. Department of Health and Human Services’ (HHS) Office of the Assistance Secretary for Preparedness and Response (ASPR) to advance the development of a blood screening test that will detect Zika virus.

ASPR’s Biomedical Advance Research and Development Authority (BARDA) will assist Hologic in the test’s development. ASPR announced its support in April for another company, Roche Molecular, for a clinical study of a Zika blood screening test to confirm whether that test accurately detects the virus in donor blood.

This is the second blood screening test ASPR’s BARDA is helping advance that may be used to test donated blood for Zika. In April, ASPR announced support of a clinical study of a Zika blood screening test developed by Roche Molecular Systems, Inc. of Branchburg, New Jersey, to confirm whether that test accurately detects the virus in donor blood.

“Accurate blood screening tools are vital to protecting our nation’s blood supply from Zika,” Richard Hatchett, acting director of BARDA, said. “This test may provide another tool laboratories can use to identify infected blood donations to help ensure patient safety. At the same time, we are pursuing promising diagnostic tools and vaccines to identify and prevent Zika virus infections.”

Under the one-year agreement, Hologic will advance the development of its Procleix Zika Virus Assay, which is designed to detect Zika virus ribonucleic acid in donated blood plasma. The contract could be extended up to a total of 18 months and $6.2 million to support a clinical study to evaluate the sensitivity and specificity of the blood donation screening test in actual use, which is necessary before it can be approved by the U.S. Food and Drug Administration for commercial marketing, if additional funding is identified for this activity.

Most people infected with Zika do not develop clinical symptoms and might donate blood not knowing that they are infected. There have been reports of blood transfusion transmission cases of Zika in Brazil, and those cases currently are being investigated. Having accurate blood donation screening tests will help ensure infected blood is removed from the blood supply.

For Further Information
More on the in vitro market in the U.S. can be found in the report series published by iData entitled US Market for In-Vitro Diagnostics Report Suite – 2016. This report covers the U.S. market segments for the Immunochemistry Market, Molecular Diagnostics Market, Molecular Blood Donor Screening Market, Hemostasis Market, Hematology Market, and Point of Care Diagnostic Device Market.

Full reports also provide a comprehensive analysis including units sold, procedure numbers, market value, forecasts, as well as detailed competitive market shares and analysis of major players’ success strategies in each market and segment. Register online or email us at [email protected] for a US Market for In-Vitro Diagnostics Report Suite – 2016 report brochure and synopsis.

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