A Medical Device Daily Staff Report
IDx (Iowa City, Iowa) said that its first commercial product, IDx-DR, has received CE approval as a Class IIa medical device. CE marking clears IDx-DR for sale in 31 countries that comprise the European Economic Area.
Developed over the course of two decades by a team of the world's leading retina experts, IDx-DR software runs on a small computer and is capable of detecting diabetic retinopathy with greater sensitivity than trained physicians. It works by running standard fundus photographs through a series of highly-advanced image filters that identify signs of the disease. By tallying these measurements and comparing them to a disease index, the algorithms built into IDx-DR have been able to consistently outperform trained physicians in diagnosing referable diabetic retinopathy.
"This is a game-changer," said IDx CEO, Gary Seamans. "CE IIa certification allows us to market a first-of-its-kind 'doc in a box' that heralds a new era for medicine."
IDx-DR represents the first in a series of diagnostic algorithms that IDx believes will ultimately transfer eye-related disease screening from the offices of ophthalmologists to patients' medical homes – whether those be family doctors or retail health clinics.
IDx says it is currently in discussions with several major healthcare device manufacturers and distributors with both domestic and international networks. The company hopes to conclude major distribution partnership arrangements this year.
Corgenix gets CE mark for ReLASV test
Corgenix Medical (Denver), a maker of diagnostic tests for cardiovascular disease, liver biomarkers and emerging pathogens and lethal viruses, received the CE Mark for its ReLASV Antigen Rapid Test for Lassa Fever diagnosis.
ReLASV is the first commercialized diagnostic test developed by Corgenix and other members of the Viral Hemorrhagic Fever Consortium (VHFC), a collaboration of academic and industry members headed by Tulane University partially funded with support from the National Institutes of Health (NIH). The new test kit enables rapid diagnosis of Lassa viral hemorrhagic fever, a highly infectious virus responsible for thousands of deaths each year across West Africa. The Lassa virus is considered a Category A (highest risk) pathogen and potential biowarfare agent by the National Institute of Allergy and Infectious Diseases (NIAID).
"This 15-minute test has the potential to completely change the way Lassa fever is detected and treated," said Douglass Simpson, Corgenix president/CEO. "Instead of having to wait days to find out if a patient has Lassa fever, health care workers are now able to diagnose and treat Lassa infections in the early acute stage, potentially saving many lives."
Corgenix diagnostic products are commercialized for use in clinical laboratories throughout the world. The company currently sells over 50 diagnostic products through a global distribution network and has significant experience in product submissions to the FDA and other worldwide regulatory authorities.
The Viral Hemorrhagic Fever Consortium was established in 2010 as a result of several multi-year grants and contracts awarded to Tulane University by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, to support Tulane's ongoing efforts to treat and prevent Lassa fever. The goal of the Consortium is to understand mechanisms related to the human immune response to Lassa virus infection. Specifically, by understanding what parts of the virus are recognized by the immune system, scientists can better understand mechanisms of antibody-mediated protection or pathogenesis in humans with Lassa fever.