EKF Diagnostics, the point of care diagnostics company, released an update on their US market expansion; The US Food and Drug Administration (FDA) have accepted EKF’s application for CLIA (Clinical Laboratory Improvement Amendments) waived status in relation to the Stanbio HemoPoint H2 Hemoglobin Measurement System. The system has been renamed the Alere HemoPoint H2 Hemoglobin Measurement System. This approval will allow Alere Inc., the exclusive distributor of EKF's HemoPoint H2 product, to begin sales into the US market.
A notice of allowance from the US Patent and Trademark Office has been received in relation to patent rights for the cuvettes that are used with the HemoPoint H2 product. The patent is expected to be granted following the payment of due fees.
EKF also reported that a South American distributor has won an order from the Mexican Institute of Social Security to supply more than 3,500 HemoPoint H2s, and related cuvettes. EKF has already received part payment via an upfront cash payment of $1.9 million. This order is part of a government initiative focusing on preventative diagnostics through the early identification and treatment of conditions such as diabetes, malnutrition, high blood pressure, high cholesterol, anaemia, and other epidemiological diseases.
The EKF share price has decreased by 3% over the past year.
EKF Diagnostic Holdings Plc is currently graded C by LCF Research. To learn more, follow the link.
