Top news of the day from across the health care landscape.
After an inspection by the FDA concluded Theranos Inc did not implement a patient-safety protocol in a study of their new miniLab device, the company withdrew its request for emergency clearance of a Zika virus blood test. According to The Wall Street Journal, the miniLab was designed for use outside a clinical laboratory to run accurate tests from only a few blood droplets. After collecting finger-stick blood samples from patients and running tests using the new device, Theranos reported that the Zika test worked. However, the FDA found that the company collected some data that supported the accuracy of the Zika test without implementing a patient-safety protocol approved by an institutional review board, reported the Journal.
By late September the Centers for Disease Control and Prevention (CDC) will run out of funding to combat the Zika virus, reported The Washington Post. This year, the CDC allocated $222 million for domestic Zika response, but CDC Director Tom Frieden stated on Monday that approximately $200 million has already been committed, and that the rest will be gone by the end of September. “Basically, we’re out of money, and we need Congress to act to allow us to respond effectively,” Frieden told the Post. “… We’re in peak mosquito season [which typically lasts through October in the US] and if transmission starts occurring more broadly, the CDC might not have the resources to respond and send teams to support local and state officials.”
Trinity health and its hospital have reached a settlement with 21 victims who were part of the nation’s largest hepatitis C (HCV) outbreak in 13 years, but the legal battle with ManorCare nursing home will continue, reported The Washington Post. Trinity attorneys filed a request to dismiss the lawsuit, stating that the company reached a confidential settlement that resolved the claims. However, attorneys asked for the legal dispute between the hospital and ManorCare to be played out in federal court, where it originated, once the individual victims are no longer involved in the case. The HCV outbreak first started in August 2013, infecting 52 people, including 48 residents or former residents of ManorCare nursing home.