13th Jan 2021 11:16
(Alliance News) - Renalytix AI PLC on Wednesday noted the creation of a US pathway to provide national Medicare coverage for new, innovative medical devices and diagnostic tests that have been authorised by the country's regulator.
Shares in Renalytix were up 7.3% at 627.50 pence in London in morning trading.
Renalytix develops testing products for kidney disease that use artificial intelligence and noted the decision relating to Medicare, the US's federal health insurance programme for those over 65. It also covers some younger people with disabilities, and those with end-stage renal disease.
The company commended the establishing off the Medicare Coverage of Innovative Technology pathway, which will give Medicare beneficiaries faster access to new medical devices and diagnostic tests. These tests must be designated under the US's breakthrough device review programme and have market authorisation from the US Food & Drug Administration.
Under the MCIT pathway, national Medicare coverage can become effective on the FDA approval date or clearance of a breakthrough device and will continue for a four year period.
After four years, continued Medicare coverage will be based on either case-by-case coverage, local coverage determination, or national coverage determination.
KidneyIntelX, Renalytix's lead product, obtained FDA breakthrough designation in May 2019 and the company submitted its DeNovo 510K application for clearance in August 2020.
Provided FDA clearance is granted in 2021, Renalytix plans to opt in for the automatic four-year National Medicare coverage period.
Along with the MCIT pathway for the KidneyIntelX test, Renalytix has also designed a prospective two thousand patient utility and outcome study aimed at further demonstrating the clinical value of KidneyIntelX testing in delaying or preventing early-stage diabetic kidney disease progression.
Renalytix President Tom McLain said: "We appreciate the opportunity to work with FDA and [Centers for Medicaid & Medicare] to tackle the critical issue of early-stage prognosis to help slow or prevent kidney disease progression. This new coverage pathway will facilitate accelerated access to KidneyIntelX for Medicare beneficiaries and their primary care doctors to help assure a better quality of life and save lives."
By Anna Farley; [email protected]
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