The National Institutes of Health (NIH) has awarded $1.5 million to continue development of diagnostic company rHEALTH's fingerstick blood test for monitoring factor VIII (FVIII) and emicizumab levels in patients with hemophilia. The medical device company DNA Medicine Institute granted rHEALTH commercial rights to the technology.
The test, from a small blood sample, provides a result in 15 minutes via a Bluetooth-connected app and "has the potential to impact the diagnosis and monitoring of hemophilia A worldwide," said Alain Baumann, CEO of the World Federation of Hemophilia.
Conventional FVIII testing in central labs requires large machines, so the point-of-care fingerstick test will be especially beneficial for patients living in developing countries, where a lack of testing materials and instruments make diagnosis and management of bleeding episodes challenging.
The World Federation of Hemophilia and Boston Children's Hospital will work with rHEALTH to test the technology in developing countries and benchmark the device's performance against hospitals' lab analyzers.