U.S. General Services Administration Grants 10-Year Governmentwide Contract for RenalytixAI KidneyIntelX Testing
KidneyIntelX Testing Services Available to 140 U.S. Government Departments, Agencies and Affiliates Around the World
NEW YORK, April 22, 2021 — Renalytix AI plc (LSE: RENX) (NASDAQ: RNLX) today announced that the United States Government has granted the company a 10-year Governmentwide Acquisition Contract (GWAC) to provide KidneyIntelX early-stage kidney disease bioprognostic™ testing services. The contract, offered through the General Services Administration (GSA), covers laboratory testing services that can be provided through more than 140 U.S. government departments, agencies and affiliates, including the U.S. Veterans Administration (VA), Department of Defense (DoD) military branches (Army, Navy, Air Force, and Marines), and Indian Health Services (IHS). The contract is effective as of April 15, 2021 and has a five-year term with a five-year extension option, and is structured as an Indefinite Delivery, Indefinite Quantity (IDIQ) contract providing for an unlimited quantity of services over the contract term. Under the contract, KidneyIntelX pricing is set at $950 per reportable result.
With the GSA contract in effect, KidneyIntelX testing is now available through the Federal Supply Schedule. Individual physicians operating within government sponsored healthcare programs can now order KidneyIntelX testing for their patients with diabetic kidney disease. Details about the GSA award and how to order the test can be found here.
The GSA contract simplifies structuring service agreements with VA facilities, military installations, and tribal nations. The contract also facilitates contracting with the VA’s regional healthcare networks (Veterans Integrated Service Networks or VISNs) to cover KidneyIntelX testing for their eligible patients.
The process to be granted a GSA contract can be considered further support for the quality and importance of KidneyIntelX testing. Securing a contract requires an application and rigorous review against specific criteria, including the status of the provider, the quality and dependability of the service provided, and the need for the testing service.
Dr. James Post, Nephrologist and Chief of Internal Medicine at the James J. Peters VA Medical Center in the Bronx, N.Y., commented, “Access to KidneyIntelX testing represents a significant development in the early detection, intervention and management of patients at risk for chronic kidney disease. With the clinical information provided by the KidneyIntelX risk score report, primary care physicians can identify and intervene early in the management of patients who are on a path for renal failure prior to direct involvement of a nephrologist or the need for dialysis.”
“This provides the opportunity for RenalytixAI to support our veterans, active military and Native American communities, and to expand our health system care delivery model,” commented Tom McLain, President at RenalytixAI. “Achieving this contracting milestone allows us to make KidneyIntelX available to patients throughout the U.S. government healthcare system. Executing on our market access strategy represents a substantial commercial opportunity for RenalytixAI.”
The GSA contract enables RenalytixAI to initiate efforts towards multiple integrated model deployments with government hospital systems. To support these efforts, RenalytixAI has formed a market access team focused on contracting with VA, DoD, and IHS facilities as well as securing coverage agreements with VISNs and the DoD’s TRICARE program to provide broad access to KidneyIntelX testing. TRICARE is the healthcare program for uniformed service members, retirees, and their families. In addition, RenalytixAI plans to expand access to veterans who could benefit from KidneyIntelX testing as part of its health system partnership programs. Several academic medical centers also provide clinical support to VA facilities.
About Kidney Disease
Kidney disease is now recognized as a public health epidemic affecting over 850 million people globally. The Centers for Disease Control and Prevention (CDC) estimates that 15% of US adults, or 37 million people, currently have chronic kidney disease (CKD). Further, the CDC reports that 9 out of 10 adults with CKD do not know they have it and one out of two people with very low kidney function who are not on dialysis do not know they have CKD.1 Kidney disease is referred to as a “silent killer” because it often has no symptoms and can go undetected until a very advanced stage. Each year kidney disease kills more people than breast and prostate cancer. Every day, 13 patients in the United States die while waiting for a kidney transplant.
KidneyIntelX, is a first-of-kind, bioprognosticTM platform that employs a proprietary artificial intelligence-enabled algorithm to combine diverse data inputs, including validated blood-based biomarkers, inherited genetics, and personalized patient data from electronic health record, or EHR, systems, to generate a unique patient risk score. This patient risk score enables prediction of progressive kidney function decline in chronic kidney disease, or CKD, allowing physicians and healthcare systems to optimize the allocation of treatments and clinical resources to patients at highest risk.
About the General Services Administration Contracting Program
The General Services Administration (GSA) is an independent agency of the United States government established in 1949 to help manage and support the basic functioning of federal agencies. Their responsibilities include the Federal Acquisition Service. The GSA Schedule (also referred to as Multiple Award Schedule (MAS) and Federal Supply Schedule) is a long-term governmentwide contract with commercial firms providing federal, state, and local government buyers access to more than 11 million commercial products and services. GSA contracts fix the rate paid for government work making it much easier to structure individual agency and department contracts. Listing on the Federal Supply Schedule also allows purchases up to defined minimum thresholds without a contract. Laboratory and medical services covered under GSA contracts are generally provided to military veterans, active military, and Native American Tribes. Laboratory services access can also be provided to certain employees of the Federal government including members of the US Senate and US House of Representatives.
RenalytixAI (LSE: RENX) (NASDAQ: RNLX) is a developer of artificial intelligence-enabled clinical in vitro diagnostic solutions for kidney disease, one of the most common and costly chronic medical conditions globally. The Company’s lead product is KidneyIntelX, which has been granted Breakthrough Designation by the U.S. Food and Drug Administration and which is being designed to help make significant improvements in kidney disease prognosis, transplant management, clinical care, patient stratification for drug clinical trials, and drug target discovery (visit www.kidneyintelx.com). For more information, visit www.renalytixai.com.
Forward Looking Statements
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Examples of these forward-looking statements include statements concerning: the potential for KidneyIntelX to receive regulatory approval from the FDA, the commercial prospects of KidneyIntelX, if approved, including whether KidneyIntelX will be successfully distributed and marketed, our expectations regarding reimbursement decisions and the ability of KidneyIntelX to curtail costs of chronic and end-stage kidney disease, optimize care delivery and improve patient outcomes. Words such as “anticipates,” “believes,” “estimates,” “expects,” “intends,” “plans,” “seeks,” and similar expressions are intended to identify forward-looking statements. We may not actually achieve the plans and objectives disclosed in the forward-looking statements, and you should not place undue reliance on our forward-looking statements. Any forward-looking statements are based on management’s current views and assumptions and involve risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. These risks and uncertainties include, among others: that KidneyIntelX is based on novel artificial intelligence technologies that are rapidly evolving and potential acceptance, utility and clinical practice remains uncertain; we have only recently commercially launched KidneyIntelX; and risks relating to the impact on our business of the COVID-19 pandemic or similar public health crises. These and other risks are described more fully in our filings with the Securities and Exchange Commission (SEC), including the “Risk Factors” section of our annual report on Form 20-F filed with the SEC on October 28, 2020, and other filings we make with the SEC from time to time. All information in this press release is as of the date of the release, and we undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise, except as required by law.