In the face of immense uncertainty, Renalytix AI remains committed to utilizing our scientific resources and technology to improve patient outcomes, both in chronic kidney disease and beyond. Read about our developmental efforts related to COVID-19 below.
Kantaro Biosciences: Joint venture for scaled production of COVID-19 antibody test kits
Renalytix has entered into a joint venture with the Icahn School of Medicine at Mount Sinai (“Mount Sinai”), Kantaro Biosciences, LLC (“Kantaro”), to develop and scale production of COVID-19 antibody test kits.
The test kits are based on the Mount Sinai-developed high-performance serologic assay for SARS-CoV-2 antibodies. Kantaro has partnered with Minneapolis-based Bio-Techne Corporation to develop and launch the new kit, with the goal of producing more than ten million patient tests per month by July. The two companies have formed a joint commercialization and distribution team to support the rapid distribution of kits to clinical laboratories in the US and around the world.
Kantaro’s SARS-CoV-2 test kits are designed for use in any authorized clinical testing laboratory without the need for proprietary equipment. The technology underlying the kits was created by a team of internationally recognized scientists and clinicians, including members from the Departments of Microbiology and Pathology, Molecular and Cell-Based Medicine within the Icahn School of Medicine at Mount Sinai. The original Mount Sinai test was validated in The Mount Sinai Hospital’s Clinical Laboratories, and has been performed on over 30,000 patient samples. The Kantaro test kit, an enzyme-linked immunosorbent assay (ELISA), builds on this test technology and is designed to measure the presence or absence of anti-COVID-19 antibodies in addition to measuring the titer (level) of antibodies a person has produced.
Mount Sinai developed the underlying assay in response to the critical needs of thousands of patients within the hospital system, including those who were severely ill and could potentially benefit from convalescent plasma for emergency therapy. Mount Sinai was issued an Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA) for clinical testing in its CLIA certified laboratory on April 15th. Kantaro plans to seek EUA for the test kit following final validation.
“Antibody testing will be critical to providing patients and governments the essential information they need to help the world economies reopen and begin to recover from COVID-19,” said Florian Krammer, PhD, Professor of Microbiology at the Icahn School of Medicine. “With the launch of Kantaro, we look forward to bringing a kit based on our highly specific and sensitive test to every corner of the globe.”
KidneyIntelX™ to predict major adverse kidney events in COVID-19 patients
The KidneyIntelX™ platform will be used by investigators from the Icahn School of Medicine at Mount Sinai to assess the risk of adverse kidney events in patients diagnosed with COVID-19. Acute and chronic kidney disease is strongly associated with severity of disease and fatal outcomes in COVID-19 patients. Evaluation of a patient’s kidney risk status at the time of COVID-19 diagnosis, through recovery and during follow-on monitoring, can be of potentially high clinical value.
The KidneyIntelX platform will be used in a large study of COVID-19 admitted patients at Mount Sinai called “Pred-MAKER” (Prediction of Major Adverse Kidney Events and Recovery). Pred-MAKER will study clinical features and biomarkers, including multiple plasma biomarkers and urine proteomics and RNA sequences, as predictors of major adverse kidney events in patients hospitalized with COVID-19. The study has been submitted for Institutional Review Board (IRB) review and approval.
Dr. Steven Coca, co-founder of RenalytixAI and co-Investigator in Pred-MAKER, stated:
“Given the evidence that there is extensive systemic inflammation as well as kidney tubular injury in patients with COVID-19, the KidneyIntelX platform is well positioned to play a prominent role in understanding which patients are at highest risk of severe kidney complications and which patients are more likely to experience longer-term detrimental effects of COVID-19 infection.”
The overall goal of the study is to improve the understanding of mechanisms of COVID-19-associated kidney disease, and to leverage the KidneyIntelX platform to deploy comprehensive machine-learned prediction models that utilize clinical data along with plasma and urine biomarkers to risk stratify Covid-19 patients into low, medium and high-risk strata for major adverse events. Dr. Coca anticipates an accelerated timeline for the conduct of the study, given the current clinical work-load impact of COVID-19 at Mount Sinai and other New York City area hospitals.