TIDMRENX
RNS Number : 1130Z
Renalytix AI PLC
08 January 2020
This announcement contains inside information
Renalytix AI plc
("RenalytixAI", the "Company" or the "Group")
New commercial testing facility opens in Utah
Utah issues CLIA Certificate of Registration to allow patient
testing
New laboratory enables five-fold test volume increase to support
2020 commercial goals
Renalytix AI plc (LSE: RENX), a developer of artificial
intelligence enabled clinical diagnostics for kidney disease,
announces that it has received a Clinical Laboratory Improvement
Amendments (CLIA) Certificate of Registration for its newly
established clinical laboratory operation in Salt Lake City,
Utah.
The Salt Lake City laboratory facility supports the delivery of
multiple elements in the Company's 2020 commercial strategy plan,
including the scaling-up of test volumes, optimizing sample
processing costs and accelerating payor coverage determinations.
With the receipt of the Certificate of Registration, the Utah
laboratory is now authorised to begin patient testing effective
immediately.
Effects of the Salt Lake City commercial laboratory
A primary benefit of the new Salt Lake City commercial
laboratory, in combination with the Company's New York City
facility, is to enable a five-fold increase in maximum potential
processing capacity to approximately 15,000 reportable test results
per month across both sites while also providing significant risk
mitigation through operational redundancy. The Salt Lake Facility
is expected to begin operating in calendar Q2 of this year.
In addition, the issuance of the Utah laboratory CLIA
Certificate of Registration allows RenalytixAI to initiate its
request for a Local Coverage Determination (LCD) from Noridian
Healthcare Solutions, the regional Medicare Administrative
Contractor (MAC) responsible for services performed in laboratories
located in the State of Utah. Once granted, the LCD applies to
payment for KidneyIntelX(TM) tests run in the Utah laboratory on
patient samples received from all 50 US states. The LCD is expected
to take approximately 12 months and would be in addition to both
coverage determination policies already adopted by insurance payor
CDPHP as announced on 17 October 2019 (RNS: 1517Q), and further
coverage determinations the Company may potentially secure from
private insurance payors during 2020 and beyond.
RenalytixAI believes that Utah represents an ideal location to
meet scaled commercial requirements in 2020 and beyond due to a
combination of attractive facility and general operating costs,
close proximity to Salt Lake City International Airport, and a
qualified pool of diagnostics personnel available for hire.
As a result of the expanded capacity and operational build-out
in Salt Lake City, RenalytixAI and AKESOgen mutually agreed to end
their testing partnership previously announced by the Company on 13
February 2019 (RNS: 8220P), with expiry effective at the end of
2019.
Update on key personnel
On 3 December 2019, Dr. Michael J. Donovan, PhD, MD, RenalytixAI
Chief Medical Officer, was granted a Utah State medical license
certifying him to oversee all Salt Lake City laboratory clinical
test reportable results in addition to results reported by the New
York City laboratory.
RenalytixAI has also recently appointed Kate Ashley, MLS, CQA,
RAC, formerly of ThermiGen (a Celling BioSciences Company), as
Director of Quality Assurance headquartered in Salt Lake City with
a direct line of report to RenaltyixAI Chief Executive Officer,
James McCullough. In addition, Baljit (BJ) Singh, MBA, MT (ASCP),
formerly Lab Director at Quest Diagnostics, has been hired as Head
of Clinical Operations overseeing daily laboratory operations in
both of the Company's laboratory facilities.
Update regarding CLIA certification
The Centers for Medicare & Medicaid Services (CMS) regulates
all clinical laboratory testing performed on humans in the U.S.
through the Clinical Laboratory Improvement Amendments (CLIA). To
ensure quality laboratory testing, all clinical laboratories must
be licensed in order to receive Medicare or Medicaid payments. The
CLIA Certificate of Registration issued to RenalytixAI for its Salt
Lake City laboratory allows it to now perform non-waived (moderate
and/or high complexity) testing at that site, until the laboratory
is inspected by the Utah Department of Health to determine its
compliance with CLIA regulations. After a successful inspection,
CMS will issue a new certificate, a Certificate of Compliance, for
the Salt Lake City laboratory. The CMS inspection is expected to
take place in the first half of calendar 2020, with subsequent
annual inspections run by the Utah Department of Health.
Five states will require a separate out-of-state license before
RenalytixAI can provide testing services for their residents:
California, Maryland, New York, Pennsylvania and Rhode Island.
RenalytixAI has initiated the application process starting with New
York State in December of 2019 and expects to initiate the
application process for the remaining four states in the first half
of calendar 2020. The Company expects the Salt Lake City Laboratory
to be licensed to perform testing for residents of all 50 states
before the end of calendar 2020.
The New York City laboratory facility is expected to receive
CLIA certification from New York State as early as Q2 2020 to be
able to conduct commercial patient testing services.
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
N+1 Singer (Joint Broker) Tel: 020 7496 3000
Aubrey Powell / 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 recognised as a public health epidemic
affecting over 850 million people globally. The Centers for Disease
Control estimates there that 15% of United States adults or 37
million people currently have chronic kidney disease. It is
reported that 9 out of 10 adults with CKD do not know they have it
and 1 out of 2 people with very low kidney function who are not on
dialysis do not know they have CKD*. 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 die in the United States while waiting for a kidney
transplant.
*
https://www.cdc.gov/kidneydisease/publications-resources/2019-national-facts.html
About RenalytixAI
RenalytixAI 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 products are being designed to make significant
improvements in kidney disease diagnosis, transplant management,
clinical care, patient stratification for drug clinical trials, and
drug target discovery.
For more information, visit renalytixai.com
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
END
MSCUWSNRRAUARRR
(END) Dow Jones Newswires
January 08, 2020 02:00 ET (07:00 GMT)
Grafico Azioni Renalytix (LSE:RENX)
Storico
Da Mar 2024 a Apr 2024
Grafico Azioni Renalytix (LSE:RENX)
Storico
Da Apr 2023 a Apr 2024