CLN - Regulatory Roundup

Qualcomm Tricorder Xprize Semi-Finalist Receives CE Mark for Hemophilia Test Kit

Regulatory Roundup: March 2018

The CE mark has been granted to rHEALTH for its Fluorogenic Factor VIII (FVIII) test kit, which measures FVIII levels in plasma from hemophilia A patients. This is the first test to receive regulatory clearance on the rHEALTH diagnostic platform, which was a semifinalist in the Qualcomm Tricorder Xprize competition to create a mobile diagnostic device modeled after the fictional medical tricorder from Star Trek. The platform is a hand-held, point-of-care instrument that is designed to run a diverse range of laboratory tests on a single small-volume blood sample.

The rHEALTH platform’s Fluorogenic FVIII test works by measuring the fluorescence of a particular peptide that indicates the quantity of FVIII. It is intended as an aid in identifying FVIII-deficient patients eligible for treatment with targeted therapeutics, such as anti-hemophilic factor therapies, and also to monitor the FVIII levels of patients already using such treatments. A hemophiliac’s FVIII levels often fluctuate and have the potential to change significantly by the time a central lab delivers a test result. By developing a test that quantifies FVIII levels at a patient’s bedside, rHEALTH hopes to enable clinicians to provide patients with more precise doses of medication.