Companies that sell devices to screen or treat blood stand to benefit from a new FDA recommendation that the entire blood supply in the U.S. and its territories be tested for the Zika virus.
Previously, the agency had advised testing of blood donations only in areas such as Florida and Puerto Rico with active virus transmission. Now it says 11 states close to these areas or having other Zika risk factors should start testing within four weeks. All other states have 12 weeks.
The added safety precautions have been put in place because “there is still much uncertainty regarding the nature and extent of Zika virus transmission,” according to Peter Marks, director of FDA’s Center for Biologics Evaluation & Research.
To handle the task, FDA has granted emergency use authorizations to companies developing as-yet-unapproved methods to test donated whole blood and blood components for Zika. Eight authorizations have been awarded since April, with the most recent going to Roche last week for its PCR-based test.
As an alternative to testing, blood centers can use an FDA-approved pathogen reduction device. In 2014, FDA approved Cerus’s Intercept Blood System for plasma and platelets. The company’s technology uses compounds that intercalate into viral DNA and irreversibly cross-link to inactivate viruses. A system for red blood cells is in Phase III clinical testing in Europe.
With 15 U.S. blood centers using its technology routinely and 30 under contract, Cerus serves 80–85% of the market, CEO William Greenman says. “We are pursuing the deployment of the red blood cell system under an investigational device exemption,” he adds.
In June, the federal Biomedical Advanced Research & Development Authority (BARDA) agreed to pay $31 million over three years to support Cerus’s near-term clinical trials. Of that, $11 million will go toward evaluating the Intercept red blood cell system in Puerto Rico. BARDA is also spending $18 million to help Terumo BCT develop its Mirasol system for treating platelets. If extended, each contract is worth more than $150 million.
Testing and pathogen reduction are designed to increase the safety of the blood supply, but they are unlikely to provide information on transmission. Only about 2% of the U.S. population donates blood annually, according to the National School of Tropical Medicine at Baylor College of Medicine.