Verici Dx PLC Acceptance to CLIA Program (5265G)
27 Julio 2021 - 1:00AM
UK Regulatory
TIDMVRCI
RNS Number : 5265G
Verici Dx PLC
27 July 2021
Verici Dx plc
("Verici Dx" or the "Company")
Acceptance to CLIA Program
Major milestone in the commercial launch of Verici Dx's lead
products, Clarava(TM) and Tuteva(TM)
Verici Dx plc (AIM: VRCI), a developer of advanced clinical
diagnostics for organ transplant, announces that it has obtained a
Clinical Laboratory Improvement Amendments (CLIA) Certification of
Registration under the Centers for Medicare & Medicaid Services
(CMS) for the Company's newly established US clinical laboratory at
the Innovation Park in Franklin, Tennessee, on which it took a
lease in late April this year.
The Certificate of Registration authorises the Company to
initiate commercial operations as a diagnostic laboratory in
Tennessee. The location was selected for the high-quality premises
within a healthcare hub to facilitate ease of logistics and hiring
in the Palmetto region. Verici Dx expects to commercially launch
its two flagship commercial products, Clarava(TM) and Tuteva(TM),
in 2022.
In addition, the issuance of the CLIA Certification of
Registration in Tennessee represents a milestone in the steps
toward seeking a coverage determination through the MolDx Program
administered by Palmetto GBA, the regional Medicare Administrative
Contractor (MAC) of CMS which is responsible for services performed
in laboratories located in the State of Tennessee and is also one
of the largest MACs in the US.
Verici Dx's two leading commercial clinical offerings,
Clarava(TM) and Tuteva(TM), are designed to support clinician
management and short and long-term graft health in kidney
transplant patients. These leading-edge technologies are
underpinned by extensive patented and published scientific research
from Mount Sinai Medical Center for which Verici Dx holds an
exclusive worldwide licence.
Michael J. Donovan, Chief Medical Officer of Verici Dx, said:
"CLIA certification is the keystone of our strategy that serves to
broaden diagnostic testing in the near term for kidney transplant
patients. This Certificate of Registration is a key milestone in
the CLIA approval pathway essential for commercial launch of the
Company's two lead products. Subject to successful conclusion of
our validation studies, having a CLIA-certified lab will allow us
to aid clinicians by using accurate, data-driven and non-invasive
detection, to support their clinical decisions and ultimately
improve kidney graft health for the tens of thousands of patients
who undergo kidney transplant each year. We look forward to
publishing validation study data on our first two products in early
2022. "
Enquiries:
Verici Dx www.v ericidx .com
Sara Barrington, CEO Via Walbrook PR
Julian Baines, Chairman
Singer Capital Markets (Nominated Adviser Tel: 020 7496 3000
& Broker)
Aubrey Powell / Justin McKeegan / Tom
Salvesen
Walbrook PR Limited Tel: 020 7933 8780 or vericidx@walbrookpr.com
Paul McManus / Sam Allen Mob: 07980 541 893 / 07748 651 727
About Verici Dx plc www.vericidx.com
Verici Dx is developing and commercialising tests to understand
how a patient will and is responding to organ transplant, with an
initial focus on kidney transplants. The body's own immune system
poses a threat to a successful transplant or graft. Patients'
immune systems differ in how they respond to the presence of the
transplanted organ, characterising this response is called immune
phenotyping. Our products and solutions are underpinned by
extensive scientific research into the recipient's immune phenotype
and how that impacts on acute rejection, chronic injury and
ultimately failure of the transplant. These immuno-profile
signatures also inform clinicians as to the optimal strategy for
immunosuppressive and other therapies for the most successful
treatment to ensure graft acceptance with the least amount of side
effects.
The foundational research was driven by a deep understanding of
cell-mediated immunity and is enabled by access to expertly curated
collaborative studies in highly informative cohorts in kidney
transplant.
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