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DNA Medicine Institute Wins $1.5M NIH Grant to Develop Point-of-Care Factor VIII, Hemlibra Test

NEW YORK — Medical technology incubator The DNA Medicine Institute last month was awarded a $1.5 million grant from the National Institutes of Health to develop a rapid, point-of-care fingerstick blood-based test for Factor VIII (FVIII) and Roche's hemophilia A treatment emicizumab (Hemlibra).

The DNA Medicine Institute's Fluorogenic Factor VIII Test is designed to monitor FVIII levels in the blood of patients with hemophilia A patients, which is caused by a deficiency in the clotting protein. The test relies on a series of reactions for FVIII, Factor IX, and Factor X, as well as phospholipids, plus the addition of S-FLXa, an internally developed peptide, in order to produce fluorophore-dependent FVIII activity that can subsequently be measured in a blood sample.

The commercial rights to the test, which received CE-IVD marking in 2018, are held by The DNA Medicine Institute spinout rHealth.

With the NIH award, The DNA Medicine Institute aims to develop the test to monitor levels of both FVIII and Hemlibra. It will develop a CLIA-waivable sample-to-answer consumable for the test and evaluate its performance with a Bluetooth-connected monitoring device and companion mobile app in hemophilia patients, according to the grant's abstract. The work will be done in collaboration with researchers at Boston Children's Hospital and the World Federation of Hemophilia.

"An easy-to-use approach for monitoring FVIII and emicizumab will improve patient care through widening availability of testing, which is today complex and hospital-based," Glenn Pierce, vice president of medical at the World Federation of Hemophilia, said in a statement.