NEW YORK — Renalytix said on Thursday that its KidneyIntelX.dkd blood-based kidney disease test has received de novo clearance from the US Food and Drug Administration.
The test uses machine learning to assess predictive blood-based biomarkers and electronic health record data to stratify adults with type 2 diabetes and early-stage chronic kidney disease by their risk for progressive kidney function decline within five years, independent of current standard-of-care measures.
The test was introduced in late 2020 as a laboratory-developed test under the name KidneyIntelX. According to London-based Renalytix, the newly cleared test is named KidneyIntelX.dkd in order to differentiate it from tests offered as LDTs.
Renalytix said that, to date, KidneyIntelX results have been reported for about 10,000 patients in the US with broad insurance payments from Medicare and various private payors.
Earlier this month, the company reported fiscal third quarter revenues of $724,000, an 11 percent decline from the year-ago period. The de novo clearance, it said, is expected to boost test adoption and expand insurance coverage, as well as inform clinical guidelines and lead to international regulatory approvals.
"With this approval, a new class, prognostic test for assessment of chronic kidney disease progression, has been established by the FDA, providing a roadmap for future expansion of KidneyIntelX into new indications and products," Renalytix CEO James McCullough said in a statement.
In a note to investors, BTIG analyst Mark Massaro noted that the FDA clearance, while not required, is expected to give clinicians added comfort in ordering the test, which is currently priced at $950 by Medicare. He added that the test recently won a coverage contract with CareFirst BlueCross BlueShield and is under contract with 41 private payors and 35 state Medicaid programs.