REG - Verici Dx PLC - Results of Tuteva™ clinical validation study

Verici DxAnnouncement

12/05/2022 07:00

For best results when printing this announcement, please click on link below:
http://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20220512:nRSL1927La&default-theme=true

RNS Number : 1927L  Verici Dx PLC  12 May 2022

Verici Dx plc

("Verici Dx" or the "Company")

 

Positive results for Tuteva™ from the international clinical validation
study

 

Performance in blinded multi-centre trial establishes new industry standard in
detection of acute kidney transplant rejection and paves way for commercial
launch in United States in 2022

 

Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for
organ transplant, announces the successful outcomes from its blinded,
international, multi-centre validation study for Tuteva™.

 

Tuteva™ is the Company's post-transplant blood test focused on acute
rejection, including sub-clinical rejection. The results of the validation
study show that the test, a next-generation RNA sequencing assay, is
demonstrating strong performance in the detection of acute rejection,
following a kidney transplant.

 

The finalised data, to be presented at the American Transplant Congress in
June 2022, demonstrates a significantly higher Positive Predictive Value
("PPV") for Tuteva™ than currently available kidney transplant blood tests,
without enhancement from clinical features, in a broad validation population.
This successfully addresses the unmet need for actionable, novel
(immune-pathway) biomarker data in this field which should assist clinicians
in improving patient outcomes.  These clinically important results position
Tuteva™ for a 2022 commercial launch to support the estimated c. 100,000
global patients who undergo kidney transplant procedures annually.

 

The strong results are particularly noteworthy given that the validation study
utilised a generalised 'all-comers' patient population rather than a specific
subgroup. The Tuteva™ study was purposefully designed this way to capture
the clinical reality of all types of rejection, including sub-clinical,
borderline, T Cell-mediated, and antibody-mediated rejection across 14
international transplant centres. The results reflect the wide clinical
applicability of the test for comprehensive commercial adoption in a
real-world setting.

 

Dr. Roslyn Mannon, Professor of Internal Medicine, the Vice Chair of Research
Mentoring and Academic Development in Internal Medicine, and Associate Chief
of Research, Division of Nephrology at University of Nebraska, said:
"Clinicians value study results that are reflective of what they see in their
patient base in their clinics.  Positive validation of Tuteva™ using a
study design for that purpose gives clinicians confidence that this test can
support critical clinician decision-making in the complex management of kidney
transplant patients. With this positive predictive performance, Tuteva™ can
now warn doctors in advance if kidney rejection is starting or likely to
occur, allowing timely intervention to improve graft function and long-term
survival."

 

Dr. Lorenzo Gallon, Medical Director of the Translational Medicine Programme,
the Director of International Relations and the Director of the Renal
Transplant Fellowship at Northwestern University, Chair, Science Advisory
Board and Non-Executive Director for Verici Dx, said: "In the kidney
transplant environment where the chance of a rejection event is high, the
clinician needs early, accurate and actionable information to make key
treatment decisions. Prior to Tuteva clinicians did not have the tools capable
of positively predicting rejections with high performance."

 

Sara Barrington, CEO, Verici Dx, said: "It is an honour to announce the
validation results of the pioneering work of the late Dr. Barbara Murphy. Spun
out of Renalytix (NASDAQ RNLX, LSE RENX), the underlying technology is proving
to be clinically groundbreaking, and we remain focused upon making this
generally available to transplant patients.   It is rewarding to see, in a
blinded study, the validation of powerful tools that support improved clinical
diagnosis of rejection allowing for more effective, earlier intervention. We
look forward to presenting the full data at the American Transplant Congress
in June."

 

In addition to this positive read-out, Verici expects to announce multi-centre
clinical validation results for Clarava™, the pre-transplant prognostic test
within the coming weeks.

 

The information contained within this announcement is deemed by the Company to
constitute inside information as stipulated under the Market Abuse Regulations
(EU) No. 596/2014 (as implemented into English law) ("MAR"). With the
publication of this announcement via a Regulatory Information Service, this
inside information is now considered to be in the public domain.

 

 

 

 

Enquiries:

 

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

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 (mailto:rns@lseg.com)
 or visit
www.rns.com (http://www.rns.com/)
.

RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our
Privacy Policy (https://www.lseg.com/privacy-and-cookie-policy)
.   END  RESGPUBPAUPPPPG