Renalytix AI PLC US CPT® Code Granted for KidneyIntelX(TM) (9350D)
July 01 2019 - 1:00AM
UK Regulatory
TIDMRENX
RNS Number : 9350D
Renalytix AI PLC
01 July 2019
Renalytix AI plc
("RenalytixAI" or the "Company")
US CPT(R) Code Granted for KidneyIntelX(TM)
CPT Code a key component for reimbursement from private medical
insurance and Medicare
Renalytix AI plc (AIM: RENX), a developer of artificial
intelligence-enabled clinical diagnostics for kidney disease,
announces that the American Medical Association (AMA) has granted a
CPT(R) Proprietary Laboratory Analyses (PLA) Code for its lead
product, KidneyIntelX(TM). The new code, 0105U, has been approved
and published by the AMA CPT Editorial Panel, and is scheduled to
become effective on 1 October 2019.
A payment rate for the new code will be established for Medicare
patients through the 2019 Clinical Lab Fee Schedule (CLFS) Annual
Public Meeting process. RenayltixAI will shortly provide comments
and a recommendation on the appropriate basis for establishing a
national Medicare price for this new CPT code expected to be
effective 1 January 2020.
Michael J. Donovan, PhD, MD, Chief Medical Officer, RenalytixAI,
said: "This is an important step as we prepare for KidneyIntelX's
scaled roll-out in the United States. A CPT Code is instrumental in
obtaining insurance coverage and reimbursement, and will increase
access to KidneyIntelX testing results for patients with chronic
kidney disease."
The CPT terminology is the most widely accepted medical
nomenclature used across the US to report medical, surgical,
radiology, laboratory, anaesthesiology, genomic sequencing,
evaluation and management services under public and private health
insurance programmes. Recently added to the CPT Code set, PLA Codes
are alpha-numeric CPT codes with a corresponding descriptor for
labs or manufacturers that want to identify their test more
specifically.
KidneyIntelX is designed to improve identification and clinical
management of patients with Type 2 diabetes with fast-progressing
kidney disease in an effort to curtail the estimated $114 billion
annual cost(1) of chronic and end-stage kidney disease to the
United States healthcare system. KidneyIntelX uses machine learning
algorithms to assess a combination of predictive blood-based
biomarkers, including sTNFR1, sTNFR2 and KIM1, and features from a
patient's electronic health record.
In a recent published study 1 April 2019, and publicly announced
by RenalytixAI on the same date, algorithms used at the core of
KidneyIntelX significantly increased the ability to positively
predict which patients went on to experience rapid kidney function
decline (RKFD). For this group of patients experiencing RKFD and at
significant risk of progressing to end-stage kidney disease and
dialysis, there are several clinical management strategies and
proven therapeutic options available. One of the greatest drivers
of health care cost today is RKFD patients who are not diagnosed in
time and face unplanned kidney failure through emergency room
'crash' dialysis.
Notes
1 United States Renal Data System -
https://www.usrds.org/adrhighlights.aspx
This announcement contains inside information. The person
responsible for arranging the release of this announcement on
behalf of the Company is James McCullough, CEO.
For further information, please contact:
Renalytix AI plc www.renalytixai.com
James McCullough, CEO Via Walbrook PR
Stifel (Nominated Adviser & Joint Broker) Tel: 020 7710 7600
Alex Price / Jonathan Senior / Ben Maddison
(Investment Banking)
Peter Lees (Corporate Broking)
N+1 Singer (Joint Broker) Tel: 020 7496 3000
Aubrey Powell / James White / George Tzimas (Corporate Finance)
Tom Salvesen / Mia Gardner (Corporate Broking)
Walbrook PR Limited Tel: 020 7933 8780 or renalytix@walbrookpr.com
Paul McManus / Lianne Cawthorne Mob: 07980 541 893 / 07584 391
303
About Kidney Disease
Kidney disease is now recognized as a public health epidemic
affecting over 850 million people globally. In the United States
alone, over 40 million people are classified as having chronic
kidney disease, with nearly 50 percent of individuals with advanced
(Stage IV) disease unaware of the severity of their reduced kidney
function. As a result, many patients progress to kidney failure in
an unplanned manner, ending up having dialysis in the emergency
room without ever seeing a clinical specialist, such as a
nephrologist. Every day 13 patients die in the United States while
waiting for a kidney transplant.
About RenalytixAI
RenalytixAI is a developer of artificial intelligence-enabled
clinical diagnostic solutions for kidney disease, one of the most
common and costly chronic medical conditions globally. The
Company's solutions are being designed to make significant
improvements in kidney disease diagnosis and prognosis, clinical
care, patient stratification for drug clinical trials, and drug
target discovery. For more information, visit renalytixai.com.
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END
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