REG - Verici Dx PLC - Successful completion of analytical validation

Verici DxAnnouncement

15/02/2022 07:00

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RNS Number : 6561B  Verici Dx PLC  15 February 2022

Verici Dx plc

("Verici Dx" or the "Company")

 

Successful completion of analytical validation for Clarava™ and Tuteva™

 

Lead products meet comprehensive requirements at CLIA-certified laboratory,
representing an important milestone towards commercialisation

 

Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for
organ transplant, announces that its two lead in vitro diagnostic assays,
Clarava™ and Tuteva™, have successfully completed analytical validation
under the CLIA(1) requirements, meeting comprehensive criteria for robust
assay performance.   Publication of the study will be made later in the year
providing key data to support clinical use.

 

Analytical validation is an essential element of defining the performance
characteristics and platform capabilities of in vitro diagnostic assays,
including reproducibility, accuracy, limits of detection, and risk of
interferences for any clinician wanting comprehensive data about the
reliability of testing.  Data collected during analytical validation is
essential for the subsequent clinical interpretation of assay results. The
process to attain analytical validation is established by regulatory
requirements under CLIA(1), and its successful completion represents an
important milestone towards commercialisation for both Clarava™ and
Tuteva™ prior to the results of the clinical validation study expected at
the end of Q1 2022.

 

The analytical validation data also represents a significant milestone in the
pathway to reimbursement. Under the Molecular Diagnostic Services Programme
("MolDx")(2), which was developed to identify and provide coverage and
reimbursement for molecular diagnostic tests under Medicare, the successful
completion and submission of analytical validation studies, in addition to the
clinical validation studies, are required for consideration of coverage.

 

Clarava™ and Tuteva™, are novel, complex RNA expression next-generation
sequencing assays coupled with proprietary prediction algorithms, that aim to
understand a patient's pre and post kidney transplant immunologic response.
The nature of assay processing for these tests requires specialised expertise
that demonstrates precise results and for which all essential performance
characteristics are verified.

 

Michael J. Donovan, Chief Medical Officer, Verici Dx, said: "2022 has started
positively for Verici Dx and this latest successful completion of analytical
validation is a significant milestone in the pathway to commercialisation,
indicating that the performance characteristics and quality design
capabilities of our lead tests meet the comprehensive regulatory requirements
as set forth by CMS through CLIA.

 

"We have previously indicated that by the end of this year, the Company will
have moved from being solely a Research and Development organisation to one
with commercial products, and the important step of analytical validation
keeps us on track to do so.  A manuscript detailing the key analytical
validation data is currently underway, which we look forward to sharing with
the clinical community in due course."

 

1.      The Clinical Laboratory Improvement Amendments or CLIA regulate
laboratory testing and require clinical laboratories to be certified by the
Center for Medicare and Medicaid Services (CMS) before they can accept human
samples for diagnostic testing.  Verici's laboratory in Nashville, TN,
obtained CLIA certification in July 2021.

2.      MolDX: Molecular Testing for Solid Organ  Allograft Rejection
(L38582); available at:
https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=38582&ver=4&bc=0
(https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=38582&ver=4&bc=0)
 

 

                                                          www.v (http://www.vericidx.com) ericidx (http://www.vericidx.com) .com

                                                        (http://www.vericidx.com)

 Verici Dx
 Sara Barrington, CEO                                     Via Walbrook PR
 Julian Baines, Chairman

 Singer Capital Markets (Nominated Adviser & Broker)      Tel: 020 7496 3000
 Aubrey Powell / Kailey Aliyar / Tom Salvesen

 Walbrook PR Limited                                      Tel: 020 7933 8780 or vericidx@walbrookpr.com
                                                          (mailto:renalytix@walbrookpr.com)
 Paul McManus / Sam Allen                                 Mob: 07980 541 893 / 07502 558 258

 

 

 

About Verici Dx plc www.vericidx.com (http://www.vericidx.com)

Verici Dx is a developer of a complementary suite of leading-edge tests
forming a kidney transplant platform for personalised patient and organ
response risk to assist clinicians in medical management for improved patient
outcomes.  The underlying technology is based upon artificial intelligence
assisted transcriptomic analysis to provide RNA signatures focused upon the
immune response and other biological pathway signals critical for transplant
prognosis of risk of injury, rejection and graft failure from pre-transplant
to late stage.  The Company also has a mission to accelerate the pace of
innovation by research using the fully characterised data from the underlying
technology and collaboration with medical device, biopharmaceutical and data
science partners.

 

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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