CMS finalises gapfill median rate at $2,650 per test
Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, announces that the Centers for Medicare & Medicaid Services (“CMS”) released the Clinical Laboratory Fee Schedule (“CLFS”) payment rate of $2,650 established through the “gapfill” process for both Tutivia™ (CPT 0320U), its post-transplant test focused upon acute cellular rejection, and Clarava™ (CPT 0319U), its pre-transplant prognosis test for the risk of early acute rejection. This rate is effective as of January 1, 2024.
Having a national payment rate established by CMS represents a step toward securing reimbursement for testing by Medicare, a national health insurance program in the US that covers 63.9 million patients. Gapfill pricing is a method used by CMS to establish a payment rate for clinical diagnostic laboratory tests when no comparable test is priced on the CLFS and involves setting the payment rate for the test at the median of rates established by local Medicare contractors.
Sara Barrington, Chief Executive Officer of Verici Dx, commented: “We are pleased that the pricing for both Tutivia™ and Clarava™ has been confirmed and finalised at the proposed rates. This is another important milestone in our strategy to develop and commercialise a complementary suite of ground-breaking products that offer end-to-end testing for kidney transplant patients and their clinicians.”
Verici Dx (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, announces that its testing laboratory in Franklin, TN, has been accredited by the internationally recognised College of American Pathology (CAP) following the completion of an on-site audit. The Company, whose clinical laboratory is already CLIA certified, voluntarily sought the accreditation as part of its on-going commitment to maintaining best in class quality systems. CAP accreditation is a hallmark of quality and excellence in clinical laboratory services and adds to the Company’s existing portfolio of quality assurance awards and recognition.
In achieving the CAP accreditation requirements, which often exceed the standards from CLIA, FDA and OSHA, Verici Dx exhibits focus on excellence in patient care and laboratory safety. It also further demonstrates the laboratory’s ability to deliver reliable and accurate test results to support patient clinical management.
Patti Connolly, Chief Operating Officer at Verici Dx, said: “We are pleased that our highly skilled laboratory team
successfully achieved this accreditation with no deficiencies, findings, or recommendations identified during the
audit. This accomplishment affirms our commitment to operating at the highest standards that healthcare
providers, patients, and regulatory bodies expect.”
Demonstrates the clinical applicability of Tutivia™ to improve patient outcomes
Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, announces that the data from the Company’s successful pivotal international validation study for Tutivia™ has been peer reviewed and published in The American Journal of Transplantation, the official journal of both the American Society of Transplantation and the American Society of Transplant Surgeons with a combined membership of approximately six thousand transplant professionals.
The publication, entitled ‘Prospective observational study to validate a Next Generation Sequencing blood RNA signature to predict early kidney transplant rejection’ by Bestard, O. et al. is available in The American Journal of Transplantation, Prospective observational study to validate a next-generation sequencing blood RNA signature to predict early kidney transplant rejection – ScienceDirect.
Tutivia™ is the Company’s post-transplant blood test that calculates the risk of all forms of acute rejection, including borderline, T cell-mediated, and antibody-mediated rejections. The test was commercially launched in January 2023 to support clinical care for the estimated c.100,000 global patients who undergo kidney transplant procedures annually.
Publication in a leading scientific journal is a crucial step in the commercialisation of a new product as the peer-review process supports the verification of the reliability and credibility of the research, building trust and confidence within the scientific community.
Publication is also a key element in the application by Verici Dx for Tutivia™ to obtain a local coverage determination
(“LCD”) for Medicare reimbursement, opening the test up for Medicare patients and increasing the likelihood of the
test being adopted by centres.
The data from the prospective, blinded study showed that Tutivia™, a next-generation RNA sequencing assay,
demonstrates strong performance in the assessment of risk of acute rejection following a kidney transplant. Tutivia™
delivers a significant improvement in biomarker offerings, particularly early post-transplant when patient management can be complex and other biomarkers are contraindicated or less informative. Patients with a high-risk Tutivia™ score are nearly six times as likely to have acute rejection over those with low-risk results. These findings confirm Tutivia™’s role in helping improve patient outcomes with significant implications for clinical care, providing relevant information for immunosuppression management and supporting clinical decision making with regard to kidney biopsy.
The strong results were particularly noteworthy given that the study utilised a generalised ‘all-comers’ patient population rather than a specific subgroup and examined performance in both the for-cause and surveillance settings. The study was purposefully designed this way to capture the clinical reality across 13 international transplant centres in five countries. As a result, the data reflects the wide clinical applicability of Tutivia™ for comprehensive commercial adoption in a real-world setting.
Dr. Lorenzo Gallon, Chair of Scientific Advisory Board of Verici Dx, commented: “I am delighted that the data from our pivotal validation study for Tutivia™ has been published in such a high-impact and prestigious journal as The American Journal of Transplantation.”
Dr Michael Donovan, Chief Medical Officer of Verici Dx, added: “This publication further validates the benefits of the test for kidney transplant patients and their clinicians, and demonstrates the comprehensive design of the study to reflect the full clinical continuum.”
Patti Connolly, Chief Operating Officer, concluded: “We are already seeing growing clinical interest, and as this publication is key in the application for LCD coverage, we anticipate an accelerated adoption of Tutivia™ within the medical community, marking a significant step forward in enhancing diagnostic accuracy and post-transplant patient care.”
Verici Dx, a developer of advanced clinical diagnostics for organ transplant, announces that it has attained the ISO 27001 certification for its Information Security Management System (“ISMS”).
ISO 27001 is an international standard specifying requirements for an ISMS, and conformity with the standard means that Verici Dx’s system meets world-wide best practice with regards to managing risks related to the security of data owned or handled by the Company.
This certification underlines Verici Dx’s commitment to implementing comprehensive security measures, ensuring the protection of sensitive data and information, and reinforces the Company’s position as a trusted partner in industry and within patient care. With this certification, Verici Dx is well-equipped to continue delivering innovative diagnostic solutions while ensuring the highest level of protection for all sensitive information.
Dave Schultenover, VP Quality and Regulatory Affairs at Verici Dx, said: “We are pleased to have achieved the ISO 27001 certification, which underscores our unwavering commitment to maintaining the utmost security and confidentiality of data within our operations.”
Patti Connolly, Chief Operating Officer at Verici Dx, added: “Achieving this international standard is testament to the quality of the Verici Dx team, and the robustness of our systems and processes that maintain the highest level of data protection for patients, clients, partners, and stakeholders.”
Agreement grants rights to further develop an assay for pre-transplant prognostic testing.
Cardiff, U.K. (November 15, 2023) – Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, today announced that it has signed an exclusive global licensing agreement with Thermo Fisher Scientific, the world leader in serving science, to further develop an assay for pre-transplant prognostic testing for risk of early kidney rejection.
Read the full press release >
International clinical validation study data to be presented at the largest global gathering of kidney health professionals
Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, announces that it will present a poster on the successful international clinical validation study for Clarava™, the Company’s pre-transplant blood-based prognostic test for the risk of early acute kidney transplant rejection, at the American Society of Nephrology’s annual conference, ASN Kidney Week, being held from 2-5 November 2023 in Philadelphia, PA.
The poster, titled “Multi-Center International Study to Validate a Pre-Transplant Blood-Based Next-Generation Sequencing (NGS) Signature Predicting Risk of Acute Rejection After Kidney Transplant”, will be presented from 10am-12pm on 2 November, in the Exhibit Hall at location TH-PO115.
The poster will describe the design and positive results of Clarava’s™ successful validation study, as previously announced, and is expected to help establish the product within the international nephrology community ahead of commercial launch.
Clarava™ is the only pre-transplant test of its kind currently available that can risk stratify patients based on their likely immune response to a transplanted organ. This allows clinicians to identify patients most likely to require increased monitoring, including increasing or decreasing adjustments in the type, dose, and duration of immunosuppressive agents. Existing approaches to assess rejection risk are standardised and typically based on the recipient’s race, age, previous transplant history and whether they have antibodies against common donor antigens. As previously reported, the Clarava™ personalised risk assessment is especially important for the expanding Deceased Donor transplant population.
Sara Barrington, CEO of Verici Dx, said: “ASN Kidney Week is an important platform for Verici Dx to raise awareness of its products including Clarava™, being the largest international gathering attended by kidney health professionals and featuring the latest advances in treatment, research and cutting edge technology in the field of nephrology.”
Continuing to build the foundations for commercial success.
Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, announces its unaudited interim results for the six months ended 30 June 2023.
Operational highlights (including post-period end)
- Initial revenues following the commercial launch of our first product, Tutivia™, the Company’s post-transplant prognostic test for the assessment of risk of acute kidney rejection.
- Full year revenues from Tutivia™ are likely to be less than expected although the Company has recently doubled the number of US transplant centers as early adopters of the test.
- The impact of lower Tutivia™ revenues is expected to be offset by higher than expected research-related revenues
so that that cash runway expectations to mid-2024 are unchanged at this time. - Successful clinical validation of our second product, Clarava™, the Company’s pre-transplant prognostic test, demonstrating a statistically significant result and capability to stratify patients based on their likely immune response to a transplanted kidney, informing a clear, actional response for clinicians.
- Clarava™ is on track for initial US commercial use by the end of 2023 under prospective real-world evidence studies.
- Completed patient enrolment for the multi-centre clinical validation study of the Company’s third product, ProtegaTM, assessing long-term outcomes for kidney transplant patients.
- Received preliminary gapfill median rate of $2,650 proposed for both Clarava™ and Tutivia™ by the Centers for Medicare & Medicaid Services (“CMS”). These rates are due to be finalised later this year and represent a substantial uplift from the Company’s initial assumption for modelling purposes.
- Two key patents granted in the United States underpinning Verici Dx’s products.
- Achieved CLIA Certificate of Compliance for clinical laboratory in Nashville, TN, USA, a key requirement to obtaining insurance reimbursement coverage under Medicare and allowing for expanded commercial launch of Tutivia™ in 49 out of 50 US states to date.
- Submitted final responses to comments for our peer-reviewed publication on the Tutivia™ clinical validation. Final publication dependent on publishers.
- Initiated studies in our databank to facilitate product development and further research collaborations.
- Obtained Medicaid approvals in 15 States and a further 12 States pending.
Outstanding clinician feedback on Tutivia™
We have been delighted with the feedback on Tutivia™ following its commercial launch at the start of 2023.
“In the first few months post-transplant there are many rejection events and yet in my opinion we have not really had a biomarker that can assist at this critical time. Tutivia™ is able to give the clinician reliable test results as soon as the first week post-transplant and so is an early biomarker test which addresses this critical need.”
Dr Nicolae Leca Professor, Medical Director, Kidney and Pancreas Transplant – University of Washington
Financial highlights
- Adjusted EBITDA loss of $4.8m (six months to 30 June 2022: loss of $5.0m), excluding share-based payments.
- $5.3m cash balance as at 30 June 2023 (31 December 2022: $9.8m).
- Net cash outflow from operating activities in the six months to 30 June 2023 was $4.7m (six months to 30 June
2022: $5.0m) with investing activities consuming a further $0.1m (six months to 30 June 2022: $0.7m).
The full year revenues are expected to be lower than originally projected from Tutivia™ but offset by higher than expected revenues from research collaborations. Revenues and containment of total costs mean that cash runway expectations to mid-2024 are unchanged at this time.
Sara Barrington, Chief Executive Officer of Verici Dx, said:
“I am proud of the progress we have made in the first six months of this year. The clinician response to our first product, Tutivia™, following its commercial launch at the start of the year clearly demonstrates how much they value the key benefits and recognise the strong differentiating features. We are also excited to have announced a second successful product, Clarava™, following the recently completed clinical validation study showing excellent results. This allows us to prepare for its initial launch in due course. We also completed enrolment for the validation study on our third product, ProtegaTM. Whilst this product has a much longer time frame, it completes the end-to-end testing for the portfolio as we look ahead.
“Although the timing effects on early adoption are frustrating, we have been able to make savings in other areas and are focused on research collaborations to help build a solid platform for future growth. At the same time, we are continuing to deliver on our strategy of transforming kidney transplant patient outcomes, as we move further into commercialisation.”
Investor briefing
Sara Barrington, Chief Executive Officer, and David Anderson, Chief Financial Officer, will provide a live presentation relating to the interim results via the Investor Meet Company platform on Thursday October 5 at 4.30pm BST.
This presentation is open to all existing and potential shareholders. Questions can be submitted 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 on the Investor Meet Company platform will automatically be invited.
A copy of the Company’s interim results report will shortly be made available on the Company’s website.
US clinical laboratory now fully accredited in 49 states
Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, announces that further to the RNS dated 2 March 2023, the Company has received compliance authorisation for the operation of its commercial clinical laboratory testing in respect of samples from an additional four US states, including the important addition of California, with the Company laboratory now fully accredited in a total of 49 states.
Together with the CLIA certification previously obtained from the Centers for Medicare & Medicaid (“CMS”), clinicians at transplant medical centres in these additional states are now enabled to order Verici Dx’s transplant tests, expanding the Company’s commercial reach. California has consistently accounted for over 10 per cent. of the national US volume of kidney transplant procedures in each year since 1998 and has conducted the highest volume of transplants by any state each year over the same period.
Verici Dx launched its first product, Tutivia™, for the detection of acute rejection in kidney post-transplant patients, in January 2023 and recently announced the successful validation of Clarava™, a first-in-class pre-transplant prognosis test for the risk of early acute rejection in deceased donor recipients, which it expects to launch later this year. The additional state accreditations provide further validation of Verici Dx’s clinical laboratory for its tests to be used by transplant clinicians across the US.
The Company continues to work towards full accreditation in the final state of New York, which has its own
compliance requirements.
The CLIA certification and additional state approvals further exemplify Verici’s commitment to a quality-focused approach to providing advanced kidney transplant diagnostic services to clinicians and patients in need.
Sara Barrington, CEO of Verici Dx, said: “This is another important step in our strategy, expanding our commercial reach and making it easier for clinicians to order our tests helping to drive the adoption of both Tutivia TM and Clarava TM .”
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 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.
Verici Dx’s two lead products are Tutivia™, a post-transplant test focused upon acute cellular rejection, including sub-clinical rejection and Clarava™, a pre-transplant prognosis test for the risk of early acute rejection. These products seek to measure how a patient is likely to respond, and is responding, to a kidney transplant. These products are underpinned by extensive patented and published scientific research from the leading Mount Sinai Medical Center, for which the Company holds an exclusive worldwide licence.
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