Death of Director

The Board of Verici Dx plc (AIM: VRCI), is saddened to announce the death of Dr. Barbara Murphy, Non-Executive Director, who passed away on June 29, 2021. Dr. Murphy had continued to fully discharge her duties as a Director through a recent period of illness, however over the past few weeks her health deteriorated. Dr. Murphy joined the Board of Verici Dx in April 2020.

Sara Barrington, Chief Executive Officer of Verici Dx, said:

“Barbara was not only a treasured colleague but a good friend and will be acutely missed by all of us at Verici Dx. She was a highly valued member of the Board, clinician and researcher, providing our Board with insightful and considered counsel.  She was passionate about the importance of providing innovative solutions to improve patient outcomes and was instrumental in providing the clinical expertise needed to put us firmly on the path towards commercial success. My colleagues and I extend our thoughts and deepest sympathy to her family.” 

The Company is in advanced discussions to appoint an additional non-executive director with appropriate specialist skills in renal transplantation.

About Dr. Barbara Murphy

Dr. Murphy was the Murray M. Rosenberg Professor of Medicine, chair of the Department of Medicine for Mount Sinai and Dean for Clinical Integration and Population Health.

Dr. Murphy earned her M.B. B.A.O. B.Ch. from The Royal College of Surgeons in Ireland and went on to do an internship at Beaumont Hospital in Dublin. She completed a residency rotation at Beaumont Hospital followed by a fellowship in Clinical Nephrology also at Beaumont Hospital. Dr. Murphy completed her postdoctoral training with a fellowship in Nephrology at Brigham and Women’s Hospital, Harvard Medical School. As part of this she trained in transplant immunology at the Laboratory of Immunogenetics and Transplantation, Renal Division, Brigham and Women’s Hospital, Harvard Medical School. Among her many honours, Dr. Murphy was awarded the Young Investigator Award in Basic Science by the American Society of Transplantation in 2003. In 2005, Dr. Murphy was awarded the Irene and Dr. Arthur M. Fishberg Professor of Medicine at The Mount Sinai Hospital. Then, in 2011, she was named Nephrologist of the Year by the American Kidney Fund. She received the distinguished Jacobi Medallion in 2014. She also received an honorary degree from University College, Dublin, Ireland. In 2016, Dr. Murphy was honoured by The Annual Irish America Healthcare & Life Science 50.

Dr. Murphy belonged to a number of professional societies including the American Society of Transplantation and the American Society of Nephrology. Among her numerous achievements, she has held many leadership roles at a national level, including being a member of the board of the American Society of Transplantation, the executive committee of the American Transplant Congress, and chair of Education Committee of the American Society of Transplantation. In 2009 Dr. Murphy was the president of the American Society of Transplantation and in 2016 was elected to council for the American Society of Nephrology.

Her area of interest was transplant immunology, focusing on the use of high throughput genomic technologies as a means to understand the immune mechanisms that lead to graft injury and loss, with the aim of identifying gene expression profiles and or genetic variants that may be used to predict those at greatest risk.

Enquiries:

About Verici Dx plc

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.

Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, announces that at today’s Annual General Meeting (“AGM”) held earlier today, all resolutions were duly passed.

The results of the AGM were as follows:

Enquiries:

About Verici Dx plc

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.

Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, announces a change in venue of its Annual General Meeting (‘AGM’), which will now take place at Harwood Capital, 6 Stratton Street, Mayfair, W1J 8LD on 19 May 2021 at 12.00pm.

As previously announced, the Company is providing a facility for shareholders to join the AGM either online or telephonically and there will be an opportunity for shareholders to ask questions. In order to facilitate the process, the Directors would request that shareholders register for the meeting and submit questions in advance, before 10.30 a.m. 17 May 2021.

To register for dial-in details and to submit any questions please contact Walbrook PR via email at ekf@walbrookpr.com or call +44 (0)20 7933 8787

No other details have changed.

Shareholders are reminded that due to the UK Government restrictions on public gatherings as a consequence of the COVID-19 pandemic, it will not be possible for shareholders to attend the AGM in person. The Board, with this in mind and in accordance with the Corporate Insolvency and Governance Act 2020, has therefore decided that the AGM will be held as a ‘closed’ meeting with the minimum number of Directors and officers who hold shares, present, to form the necessary quorum. Regrettably, other shareholders will not be permitted to attend the meeting in person.

Copies of the Annual Report and Accounts and Notice of AGM are available on the Company’s website here:

https://vericidx.com/investors/annual-reports/

Enquiries:

Sara Barrington, CEO
Julian Baines, Chairman

www.vericidx.com
Via Walbrook PR

N+1 Singer (Nominated Adviser & Broker)
Aubrey Powell / Kailey Aliyar / Tom Salvesen

Tel: 020 7496 3000

Walbrook PR Limited
Paul McManus / Sam Allen

Tel: 020 7933 8780 or vericidx@walbrookpr.com
Mob: 07980 541 893 /
07748 651 727

About Verici Dx plc

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.

About Mount Sinai Health System

The Mount Sinai Health System is New York City’s largest academic medical system, encompassing eight hospitals, a leading medical school, and a vast network of ambulatory practices throughout the greater New York region. Mount Sinai is a national and international source of unrivaled education, translational research and discovery, and collaborative clinical leadership ensuring that we deliver the highest quality care—from prevention to treatment of the most serious and complex human diseases. The Health System includes more than 7,200 physicians and features a robust and continually expanding network of multispecialty services, including more than 400 ambulatory practice locations throughout the five boroughs of New York City, Westchester, and Long Island. The Mount Sinai Hospital is ranked No. 14 on U.S. News & World Report’s “Honor Roll” of the Top 20 Best Hospitals in the country and the Icahn School of Medicine as one of the Top 20 Best Medical Schools in country. Mount Sinai Health System hospitals are consistently ranked regionally by specialty and our physicians in the top 1% of all physicians nationally by U.S. News & World Report.

For more information, visit https://www.mountsinai.org or find Mount Sinai on Facebook, Twitter and YouTube.

Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, announces it has signed the lease for the premises intended to be the CLIA¹-certified laboratory, situated at the Innovation Park² in Franklin, Tennessee, US, which is within the Palmetto region for CMS Medicare governance. Palmetto GBA, LLC is one of the largest Medicare administration contractors in the US.

In January 2021, the Company appointed David Schultenover to accelerate the CLIA approval process to enable faster commercial launch of Verici Dx’s lead products, Clarava^TM and Tuteva^TM and setting up these premises is the first step in that accelerated pathway. The Company requires a CLIA-certified laboratory to be able to offer their diagnostic products to clinicians as a laboratory developed test (LDT) and approvals are expected by the end of the year. The Center for Medicare and Medicaid Services (CMS) regulates laboratory testing in the US through the CLIA regime, which requires all clinical laboratories to be certified before they can accept human samples for diagnostic testing.

David Schultenover, VP Quality and Regulatory Affairs at Verici Dx, commented: “I joined the Company in January this year to help expedite the CLIA approval strategy and signing the lease to this space marks the first step towards achieving these CLIA approvals necessary for commercial launch of the Company’s leading products, Clarava^TM and Tuteva^TM. Innovation Park is an ideal location for the Company to establish operations and we are delighted with the quality of the premises which are well suited for our needs.” 

1. CLIA – Clinical Laboratory Improvement Amendments
2. Innovation Park is a 10 acre campus for growing start-ups or established companies. More information can be found here: http://www.theinnovationpark.com/#campus

Enquiries:

Verici Dx
Sara Barrington, CEO
Julian Baines, Chairman

www.vericidx.com
Via Walbrook PR

N+1 Singer (Nominated Adviser & Broker)
Aubrey Powell / Kailey Aliyar / Tom Salvesen

Tel: 020 7496 3000

Walbrook PR Limited
Paul McManus / Sam Allen

Tel: 020 7933 8780 or vericidx@walbrookpr.com
Mob: 07980 541 893 /
07748 651 727

About Verici Dx plc

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.

Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, announces it has entered into a Material Transfer Agreement (“MTA”) with the Icahn School of Medicine at Mount Sinai and Principal Investigator Dr. Peter Heeger, to allow access to samples from the CTOT-19 (Clinical Trials in Organ Transplant¹) trial in an effort to validate the performance and development of commercial tests designed to improve short and long-term graft and patient survival.

The Company has secured an agreement, providing access to de-identified samples generated from participants in the CTOT-19 study, titled: “Effects of Inhibiting at Early Inflammation in Kidney Transplant Patients.”² This randomised controlled trial was initiated in November 2015 with the aim to enrol 300 kidney transplant recipients at 15 transplant centres in the US and Canada, with a primary completion date expected July 2021.

Access to samples from this important clinical trial, in addition to the Verici Dx clinical study already ongoing for the validation of Clarava™ and Tuteva™, provides the Company with a large and well-characterised sample group. The Company’s laboratory will conduct a blinded evaluation of samples in Clarava™ and Tuteva™ and work with investigators, including Dr. Peter Heeger, to characterise results following the data lock later this year.  The Company will further support this important CTOT programme by providing full transcriptomic sequencing to the investigators to augment ongoing research in mechanistic studies.

Dr. Barbara Murphy, Chair of Science Advisory Board of Verici Dx, commented: “We are extremely pleased for the opportunity this MTA represents and to collaborate with Dr. Peter Heeger and CTOT. We look forward to the assessment of the clinical performance validation of both Clarava and Tuteva as laboratory developed tests and to furthering research endeavours in organ transplant.”

The test described is based on technology developed by Mount Sinai faculty and licensed to Verici Dx. Mount Sinai and the Mount Sinai faculty who developed this technology, including Dr. Barbara Murphy, have a financial interest in Verici Dx.

References:

1. CTOT Home (ctotstudies.org) CTOT is a cooperative research programme sponsored by the National Institute of Allergy and Infectious Diseases (NIAID). CTOT is an investigative consortium for conducting clinical and associated mechanistic studies that will lead to improved outcomes for transplant recipients. The purpose of these studies is to improve short and long-term graft and patient survival.
2. Effects of Inhibiting Early Inflammation in Kidney Transplant Patients – Full Text View – ClinicalTrials.gov

Enquiries:

Sara Barrington, CEO
Julian Baines, Chairman

www.vericidx.com
Via Walbrook PR

N+1 Singer (Nominated Adviser & Broker)
Aubrey Powell / Kailey Aliyar / Tom Salvesen

Tel: 020 7496 3000

Walbrook PR Limited
Paul McManus / Sam Allen

Tel: 020 7933 8780 or vericidx@walbrookpr.com
Mob: 07980 541 893 /
07748 651 727

About Verici Dx plc

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.

About Mount Sinai Health System

The Mount Sinai Health System is New York City’s largest academic medical system, encompassing eight hospitals, a leading medical school, and a vast network of ambulatory practices throughout the greater New York region. Mount Sinai is a national and international source of unrivaled education, translational research and discovery, and collaborative clinical leadership ensuring that we deliver the highest quality care—from prevention to treatment of the most serious and complex human diseases. The Health System includes more than 7,200 physicians and features a robust and continually expanding network of multispecialty services, including more than 400 ambulatory practice locations throughout the five boroughs of New York City, Westchester, and Long Island. The Mount Sinai Hospital is ranked No. 14 on U.S. News & World Report’s “Honor Roll” of the Top 20 Best Hospitals in the country and the Icahn School of Medicine as one of the Top 20 Best Medical Schools in country. Mount Sinai Health System hospitals are consistently ranked regionally by specialty and our physicians in the top 1% of all physicians nationally by U.S. News & World Report.

For more information, visit https://www.mountsinai.org or find Mount Sinai on Facebook, Twitter and YouTube.

Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, announces its inaugural audited results for the period ended 31 December 2020.

Strategic and Operational highlights

• Verici Dx was successfully admitted to AIM in November raising gross proceeds of c.$18.8m (£14.5m)
  • The fundraising was significantly oversubscribed by institutional and other investors, and the current share price has notably outperformed the market since IPO
  • The net proceeds are being used primarily to fund the clinical utility and validation studies for lead products Clarava™ and Tuteva™, as well as other bioinformatics and health economic studies
• Appointed Angela Rose as Senior Director of Clinical Trial Operations in December 2020 to oversee the clinical trials to their conclusion

Financial highlights

• Adjusted EBITDA loss of $1.24m¹
• Cash balance at 31 December 2020 of $17.8m

Post-period end

• Expanded scope of licence agreement with Mount Sinai, in January 2021, to include an additional patent filing related to the analysis of gene expression in a blood-based test (liquid biopsy) to predict risk of fibrosis (chronic kidney graft damage) and rejection of the graft
• Accelerated CLIA¹ approval strategy to enable faster commercial launch of leading products
• In February 2021, appointed David Schultenover as Vice President of Quality and Regulatory to project manage the accelerated CLIA approval strategy

Commenting on the outlook, Julian Baines, Non-executive Chairman, said: “We have been very pleased with the progress of the Company in such a short time and our primary focus remains on the successful prosecution of our clinical trials, as the first key step in commercialising our innovative transplant products.

“We are already making good progress, initially partnering with three leading US centres (Northwestern University Feinberg School of Medicine, Henry Ford Health System and University of Maryland, Baltimore) in our collaborative, multi-centre observational clinical validation study. We expect to bring more US sites on board shortly and are currently also progressing discussions to include a number of EU sites, to ensure that our products are fully tested for validation by the end of 2021, in line with our objectives set out at the time of our IPO.

“On behalf of the Board, I would like to thank our employees, stakeholders and shareholders for their support and we look forward to providing further updates on progress throughout the current year.”

Notes:

1. Earnings before income tax, depreciation and amortisation, adjusted to exclude exceptional items and foreign exchange loss
2. The CLIA (Clinical Laboratory Improvement Amendments) regime is used by the Center for Medicare and Medicaid Services (CMS) to regulate laboratory testing in the US, and requires all clinical laboratories to be certified before they can accept human samples for diagnostic testing

Investor briefing

Sara Barrington, Chief Executive Officer, and David Anderson, Chief Financial Officer, will provide a live presentation relating to the Final Results via the Investor Meet Company platform on Wednesday 14 April 2021 at 5.00 p.m. (BST).

The presentation is open to all existing and potential shareholders. Questions can be submitted pre-event via your Investor Meet Company dashboard up until 9.00 a.m. the day before the meeting or at any time during the live presentation.

Investors can sign up to Investor Meet Company for free and add to meet VERICI DX PLC via:

https://www.investormeetcompany.com/verici-dx-plc/register-investor

Investors who already follow Verici Dx plc on the Investor Meet Company platform will automatically be invited.

Enquiries:

About Verici Dx plc

Verici Dx is an immuno-diagnostics company 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.

Chairman’s statement

I am delighted to report on the first annual results for Verici Dx plc since admission to AIM in November 2020 and this report covers the period from the Company’s incorporation on 22 April 2020 to 31 December 2020.

A full description of our strategy and business model is provided in the Strategic Report below, however in summary Verici Dx is an immuno-diagnostics development company, initially focussed on the kidney transplantation market, incorporating the FractalDx technology and associated assets previously owned by Renalytix AI plc and licensed from the Icahn School of Medicine at Mount Sinai, New York.

We have two leading products which aim to understand how a patient will and is responding to kidney transplantation and these have started clinical validation trials:

• Clarava™, which is a pre-transplant prognosis for the risk of early acute rejection; and
• Tuteva™, a post-transplant diagnostic focused upon acute cellular rejection, including sub-clinical rejection not being diagnosed through the current standard of care of rising serum creatinine levels.

Our kidney transplant assays use advanced next-generation sequencing that we believe can define a personalised risk profile for each patient over the course of their transplant journey and can detect injury in advance of currently available clinical tests, with a view to minimising risk of transplant rejection.

The initial focus of Verici Dx on the kidney transplantation market reflects the urgent clinical need in this area. According to the World Health Organisation (WHO), there are reports to suggest that between five and ten million people die annually from kidney disease (compared to 1.8m who die from the most prominent cancer, lung cancer) and about 300,000 people around the world are currently on a waiting list waiting for a kidney transplant and is expected to rise due to an increase in kidney disease. We believe we have unique kidney transplant diagnostic technology that enables accurate, data-driven support for clinical decisions, such as the most appropriate immunosuppressive therapy for that patient.  This has not only near-term scope to reduce the unnecessary and serious consequences from over- or under-dosing for immunosuppression, but also to improve the longevity of transplanted kidneys and, by reducing the risk and rate of transplant failure, much broader potential to deliver huge health economic benefits by improving transplant outcomes.

In early November last year, Verici Dx was successfully admitted to trading on AIM, raising gross proceeds of c.$18.8m (£14.5m). The fundraising was significantly oversubscribed by institutional and other investors, and the share price has appreciably outperformed the market in the period since then. The net proceeds are being used primarily to fund the clinical utility and validation studies for Clarava™ and Tuteva™, as well as other bioinformatics and health economic studies.

We are already making good progress initially partnering with three leading US centres (Northwestern University Feinberg School of Medicine, Henry Ford Health System and University of Maryland, Baltimore) in our collaborative, multi-centre observational clinical validation study. We expect to bring more US sites on board shortly and are currently also progressing discussions to include a number of EU sites, to ensure that our products are fully tested for validation by the end of 2021, in line with our objectives set out at the time of our IPO.

I am also very pleased that we have been able to announce further key milestones in the development of our strategy during the reporting period and post-period end:

• In December 2020, we announced the appointment of Angela Rose as Senior Director of Clinical Trial Operations. Angela has over 15 years’ experience in clinical trial project management and she will be instrumental in overseeing the clinical trials to their conclusion.
• In January 2021, we announced the expansion of the scope of our licence agreement with Mount Sinai to include an additional patent filing related to the analysis of gene expression in a blood-based test (liquid biopsy) to predict risk of fibrosis (chronic kidney graft damage) and rejection of the graft. Assuming successful development, the addition of a product that can predict the risk of long-term graft failure will establish an end-to-end solution for clinicians seeking to understand how a patient will and is responding to organ transplant.

Three leading US centres first to collaborate with Verici in clinical validation trial for lead products

Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, announces that it has partnered with Lorenzo Gallon, MD, at Northwestern University Feinberg School of Medicine; Milagros Samaniego, MD, at Henry Ford Health System and Daniel G. Maluf, MD, at the University of Maryland, Baltimore to collaborate on Verici Dx’s clinical trial surrounding its two lead products, Clarava^TM and Tuteva^TM, and longer term, the validation of the fibrosis test.

The study uses next generation sequencing in the Verici Dx laboratory to create transcriptomic profiles to validate performance characteristics of the lead Verici Dx immune-phenotype signature tests.

Professor of Medicine (Nephrology and Hypertension) and Surgery (Organ Transplantation), Dr. Gallon is an alumnus of the University of Padua Medical School, Italy and is the Medical Director of the Translational Medicine Programme, the Director of International Relations and the Director of the Renal Transplant Fellowship at Northwestern University.

Dr. Samaniego is the Medical Director of Kidney and Kidney Pancreas Transplantation and Director of Research and Outreach Kidney Transplant Program the Henry Ford Transplant Institute with over 21 years of experience. She completed her residency at Baylor College of Medicine and her fellowship at Johns Hopkins Hospital. She is an American Society of Nephrology and American College of Physicians fellow, and her research has been focused on antibody-mediated rejection and studying new immunosuppression approaches to optimize the success of kidney transplants.

Dr. Maluf, Director of the Program in Transplantation at the University of Maryland School of Medicine, performs renal transplantation at the University of Maryland Medical Centre. He has clinical and scientific expertise in kidney and liver transplantation, including living donor liver transplantation. Dr. Maluf is nationally and internationally recognized for his work with the American Transplant Society and the International Liver Transplant Society.

Sara Barrington, CEO of Verici Dx, said:

“We are delighted at the level of global interest in our validation trial and highly appreciative that these centres were able to lead our first clinical trials in the United States. Lorenzo, Milagros and Daniel have excellent, demonstrable track records in the medical industry, and have collectively helped pioneer organ transplant research in the modern era. We are excited to be onboarding more US sites shortly and are currently progressing with a number of EU sites to ensure that the two leading products are fully tested for validation by the end of the year.”

Enquiries:

Worldwide exclusive licence to liquid biopsy IP for predicting risk of fibrosis and chronic damage rejection
Strengthens patent portfolio covering the entire kidney transplant diagnostic pathway

Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, announces that it has expanded the scope of its licence agreement with the Icahn School of Medicine at Mount Sinai (“Mount Sinai”) to include an additional patent filing related to the analysis of gene expression in a blood-based test (liquid biopsy) to predict risk of fibrosis (chronic kidney graft damage) and rejection of the graft.

Interstitial fibrosis and tubular atrophy (IF/TA) is a significant complication in 50-65% of transplants at 12-24 months¹ and a major cause of graft rejection in the first year after transplantation².

The development of a product that can predict risk of fibrosis and rejection using the Company’s core technological approach would extend Verici Dx’s portfolio across the full course of a patient’s transplant journey and complement the Company’s two flagship in vitro diagnostic assays, Clarava™ and Tuteva™. Clarava™ is a pre-transplant prognosis test for the risk of early acute rejection, and Tuteva™ is a post-transplant diagnostic focused upon acute cellular rejection. A further product using this technological approach and focused on risk of fibrosis would support the diagnosis of risk of longer-term graft failure as well.

The development of a novel blood-based immune-phenotyping prognostic test for risk of fibrosis fits well with Verici Dx’s current laboratory capabilities, instrumentation and expertise. Liquid biopsy also allows for easier deployment in clinical care given the limited population of transplant centres that undertake tissue allograft surveillance biopsies and the lower risk and costs associated with blood-based biopsies.

The Company’s multi-centre observational clinical study to validate the clinical performance of Clarava™ and  Tuteva™ will also include patients being assessed for fibrosis for an extended study period beyond the initial end points for the first two products  in order to collect data in support of validation for this newly licensed test to predict risk of fibrosis.

Commenting Sara Barrington, CEO of Verici Dx, said:

“The development of a product that can predict the risk of long-term graft failure, alongside our flagship products Clarava™ and Tuteva™, would establish an end-to-end solution for clinicians seeking to understand how a patient will and is responding to organ transplant. There is a critical need for more personalised diagnostic information within transplant care, and in particular technologies informing earlier interventions with anti-fibrotic therapies in advance of irreversible organ damage.”

Notes

1. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4065724/#B41
2. Nankivell et al. The Natural History of Chronic Allograft Nephropathy, NEJM 2003

Enquiries: