Cambridge, Mass., January 8, 2018 – rHEALTH LLC., today announces CE marking of its Fluorogenic Factor VIII (FVIII) Test Kit*. It has met the requirements of CD 98/79/EEC (the European IVD Directive) and is pleased to affix the CE Mark to its rHEALTH Fluorogenic FVIII Kit for Professional Use Only.
The rHEALTH Fluorogenic FVIII Kit is a diagnostic assay intended to quantify the amount Factor VIII levels in human plasma. The assay may be used to aid in the identification of FVIII-deficient patients eligible for treatment for targeted therapeutics, such as anti-hemophilic factor therapies, and may also be used for monitoring the Factor VIII levels of patients using such products. Importantly, the new rHEALTH Fluorogenic FVIII kit offers a method that requires fewer steps compared to similarly sensitive factor assays—which traditionally have complicated protocols with multiple steps. The kit is compatible with the rHEALTH diagnostic platform technology†.
Characterized by deficiency in clotting factor VIII, hemophilia A is a bleeding disorder that affects around 150,000 people worldwide. The condition accounts for over half of all individuals identified with bleeding disorders according to the World Federation of Hemophilia. Approximately 400 males born in Europe annually are diagnosed with hemophilia. Due to important therapeutic implications, routine testing for factor VIII deficiency is required throughout the patient’s life.
"This CE marking represents a major milestone both for our company and for patients with hemophilia A,” stated Dr. Eugene Y. Chan, rHEALTH’s Founder and CEO. “Living with hemophilia is a significant burden for patients and it has been an important focus area in our work towards making diagnostics more accessible. We intend to offer this assay broadly in Europe as we seek additional regulatory approvals elsewhere.”
rHEALTH is an innovative digital health solutions company focused on creating integrated technologies that fundamentally change how we care for our health. rHEALTH’s innovations consists of the rHEALTH diagnostic platform, which enables diverse laboratory test classes from a single small volume blood sample intended as a point-of-care solution, the SKYE Sensor, a wireless wearable providing comprehensive real-time vitals monitoring and CHAS, a user-friendly mobile application. For more information, visit www.rhealth.com.
*Not available for sale in the USA.
†For research use only. Not for use in diagnostic procedures.