The researchers said the test performed well in distinguishing patients with or without complications and proved itself better than frequently used clinical variables.
The mass spec test is designed to measure blood-based proteins to predict type 2 diabetes patients' risk of developing diabetic kidney disease.
The firm said the clearance authorizes use of its smartphone-based albumin-to-creatinine ratio test by healthcare professionals at the point of care.
The firm anticipates that point-of-care adoption may attract licensing deals from companies interested in adding the biomarkers to their large laboratory analyzers.
The UCSF spinout aims to develop noninvasive tests to detect kidney injury for the transplantation field and to diagnose and monitor chronic disease.
The company's new KidneyCare test will include AlloSure for rejection, AlloMap for quiescence, and Cibiltech's AI algorithm for graft health information.
The test uses machine learning algorithms to assess predictive biomarkers and electronic health record information to identify progressive kidney disease.
The firm said that its Vitros XT MicroSlides improve lab turnaround time by delivering simultaneous results for pairs of tests that physicians frequently order.
The firm has expansive plans, including a possible launch of 40 different types of tests. It currently plans to launch a liver function test in the US this summer.
The companies today launched four assays for the Chinese market for renal, liver, and cardiac testing for use on the Vitros 4600 and Vitros 5600 systems.