Abbott (NYSE:ABT) said today that the FDA approved its RealTime ZIKA test to detect Zika virus in whole blood for emergency use. This is the 1st molecular test made by a commercial manufacturer that the federal watchdog has authorized to detect Zika in whole blood samples, the company touted.
Research suggests that Zika virus can be detected in whole blood for a longer period of time and at higher levels compared to serum and urine sample types, according to Abbott.
The company’s RealTime ZIKA test was developed to be used with its m2000 RealTime molecular diagnostics instrument. The automated test yields results in 5 to 7 hours and is highly sensitive, Abbott reported.
“Diagnosing a Zika infection can be challenging, especially since people might not have any symptoms or only have mild symptoms that last a few days,” John Hackett, Diagnostics Products divisional VP of applied research & technology, said in prepared remarks. “Abbott’s molecular test may provide the ability to identify the active virus over a longer time period with whole blood and could provide a more accurate diagnosis. Our test can also distinguish Zika from other viruses such as dengue or chikungunya, which helps doctors make informed diagnoses to help people get back to better health.”
Yesterday, Abbott said today that the FDA approved magnetic resonance-conditional labeling for its Assurity MRI pacemaker and its Tendril MRI pacing lead. The watchdog’s approval makes its Assurity device the world’s smallest, longest-lasting wireless MRI-compatible pacemaker, the company reported.
During an MRI scan, Abbott’s MRI Activator device triggers pre-programmed MRI settings for the Assurity pacemaker, eliminating the need for conventional pre- and post-scan pacemaker reprogramming.
The Assurity pacemaker also features wireless remote monitoring so physicians can access their patients’ diagnostic data and daily measurements, lessening the need for frequent in-office visits, according to Abbott.