Clarava™, a first-in-class pre-transplant prognostic test for risk of early kidney rejection,
On track for US commercial launch by end of 2023
Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, announces successful validation results from its prospective, blinded, international multi-centre clinical validation study for Clarava™. Clarava™, is the first pre-transplant prognostic test to enable measurement of a patient’s immune response to assess the risk of early kidney graft rejection. The validation study represents a significant demonstration of Clarava™ as a predictive test capable of informing a clear, actionable response from clinicians for an estimated 65,000 eligible patients on an annual basis.
Verici Dx is on track to commence the initial US commercial launch of Clarava™ before the end of 2023. The Company has received a preliminary Medicare gapfill median rate of $2,650 for Clarava™ from the Centers for Medicare & Medicaid Services (“CMS”).1
“There is a desperate global need for an effective, personalised pre-transplant test that can identify the risk of kidney transplant rejection to inform treatment decisions. The suboptimal dosing of immunosuppressants can have detrimental consequences for patients and create additional, unnecessary healthcare costs. Clarava™ has the potential to transform kidney transplant treatment protocols and improve outcomes for patients,” said 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 of the Verici Dx Science Advisory Board and Non-Executive Director of the Company.
The Clarava™ study, which included a broad and diverse group of 122 patients preparing to receive a kidney transplant and a range of rejection outcomes across 13 centres, demonstrated a statistically significant result with a sensitivity of 78% and specificity of 64%, identifying patients that are at increased risk for a kidney rejection event in the critical first 60 to 90 days post-transplant, after receiving a kidney from a deceased donor (“DD”). Study data analysis of the clinical performance of Clarava™ demonstrated differentiation of high-risk and low-risk patient groups, determining that patients of high risk were approximately six times more likely to have a rejection than those of low risk. This represents a significant demonstration of Clarava™ as a predictive test capable of informing for a clear, actionable response from clinicians. Whilst DDs provide the majority of kidney transplants, the Company will be also exploring further samples drawn from Living Donor (LD) transplant recipients, in addition to assessing the anticipated combination of using our pre-transplant test, Clarava™ in conjunction with our post-transplant test, Tutivia™.
Clarava™ is the only pre-transplant test of its kind 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 adjustments in the type, dose, and duration of immunosuppressive agents. Existing approaches to assess rejection risk are standardized and typically based on the recipient’s race, age, previous transplant history and whether they have antibodies against common donor antigens. As reported, the Clarava™ personalized risk assessment is especially important for the expanding DD transplant population.
Sara Barrington, CEO of Verici Dx, said: “This validation for Clarava is the second successful product to emerge from the Company’s suite of prognostic RNA signature tests and further validates our underlying technology platform. With Tutivia™ commercially launched as a measure for post-transplant rejection risk, the addition of Clarava™ as a pre-transplant test is a significant milestone in our strategy of building a complementary suite of ground-breaking products that offer end-to-end testing for kidney transplant patients and their clinicians, to help personalise care and transform outcomes.”
Verici Dx is on track to commence the initial US commercial launch of Clarava™ before the end of the year to support the utility case studies and will be offered in conjunction with its other lead product, Tutivia™, which is already available in the US. The Company intends to leverage its existing internal resources and growing network of early adopters to develop the clinical positioning and marketing collateral for both products.
Notes
1The proposed CMS rate is currently open for public comment before it is finalised later this year. Following finalisation, the price in the Clinical Laboratory Fee Schedule (“CLFS”) is valid for a period of three years from 1 January 2024, after which it is subject to further review.
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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Medicare proposed gapfill median rate of $2,650 per test
Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, announces that a gapfill median rate of $2,650 has been proposed for Tutivia™ for kidney transplant rejection by the Centers for Medicare & Medicaid Services (“CMS”).
Medicare is a national health insurance program in the US that covers 63.9 million patients. Gapfill pricing is a method used by CMS to establish payment rates for clinical laboratory tests under the Clinical Laboratory Fee Schedule (“CLFS”) when no comparable test already exists on the CLFS. The proposed rate was supported by the majority of Medicare Administrative Contractor (“MAC”) localities, including Palmetto GBA, the MAC that will process future Medicare claims submitted for tests performed in Verici’s Tennessee laboratory. This proposed rate is currently open for public comment before it is finalised later this year. Following finalisation, the price in the CLFS is valid for a period of three years from 1 January 2024, after which it is subject to further review.
Sara Barrington, Chief Executive Officer of Verici Dx, commented: “This is another important milestone in our commercial strategy, and we are pleased the majority of MAC localities have proposed pricing for our Tutivia™ tests consistent with the resources required to develop and perform these tests. I look forward to the pricing being finalised later this year and securing reimbursement coverage in due course.”
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.
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.
Successful transition from a research to commercial-stage company
Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, announces its audited final results for the year ended 31 December 2022 and provides a progress update since year end.
Strategic progress (including post-period end)
- Achieved full commercial launch of Tutivia™, the Company’s first product for the detection of acute
kidney transplant rejection, in January 2023, leading to first revenues being recognised in FY 2023. - Expanded its validation trial on Clarava™, the Company’s pre-transplant prognostic test, for a further six
months following positive initial data announced in September 2022. This decision was taken to
strengthen the publication appeal of the trial and demonstrate a statistically robust and clinically
compelling case in support of the commercial rollout and adoption of the test. The full readout from this
trial remains on track to be announced by the end of June 2023, in line with previous guidance. - Patient enrolment for the multi-centre clinical validation study of our third product, ProtegaTM, was
completed in the first quarter of 2023, assessing long-term outcomes for kidney transplant patients. - Extended cash runway until mid-2024; the Company has retained sufficient funding to achieve further
key milestones in 2023 and the first half of 2024 which will support commercial adoption, including the
publication of additional data and obtaining both Medicare and private payor pricing and coverage. A
further commercial and operational update will be provided alongside the Clarava™ data readout.
Operational highlights (including post-period end)
- Announced positive results from the Tutivia™ clinical validation study in June 2022, for the detection of
acute rejection following a kidney transplant. - Granted CPT® Proprietary Laboratory Analyses (“PLA”) codes for Clarava™ and Tutivia™ tests by the
American Medical Association (“AMA”), providing the basis for coding and payment within the US
healthcare market. - In May 2023, a gapfill median rate of $2,650 was proposed for Tutivia™ for kidney transplant rejection
by the Centers for Medicare & Medicaid Services (“CMS”) in line with the Company’s application. - Obtained Medicaid approvals in 14 States and a further 11 States are pending.
- Two key patents granted in the United States underpinning Verici Dx’s products.\
- Achieved CLIA Certificate of Compliance for laboratory in Nashville, TN, USA, a key requirement to
obtaining insurance reimbursement coverage under Medicare and allowing for expanded commercial
launch of Tutivia™, in 45 US states. - Completed analytical validation for Clarava™ and Tutivia™ in February 2022, an essential element of
defining the performance characteristics and platform capabilities of in vitro diagnostic assays and a key
milestone towards commercialisation. - Announced a collaboration with Illumina, Inc., for early access to the Illumina Connected Analytics (ICA)
platform to expedite the operational launch of data analysis processing and predictive artificial
intelligence component of Verici’s products in due course.
Financial highlights
- Adjusted EBITDA1 loss of $10.5m (2021: loss of $7.1m).
- Cash balance at 31 December 2022 of $9.81m (2021: $10.3m).
- Raised gross proceeds of £10.0m in March 2022 via Placing and Subscription.
- Cash runway extended to mid-2024.
Commenting on the performance and outlook, Sara Barrington, Chief Executive Officer, said:
“2022 was a transformational year for Verici Dx; we began the year as an R&D-stage company, and have now
commercially launched our first product, Tutivia™, following pleasing validation study results.
“We are well placed to deliver further progress against our strategy in 2023, building on the initial rollout of
Tutivia™ and we remain on track to announce the data read-out from the extended Clarava™ trial by the end
of June. In addition, we are taking further steps towards reimbursement that will help accelerate commercial
uptake of our lead products.”
Investor briefing
As previously announced, an investor meeting covering the FY22 financial results will be provided following
the data read-out from the extended Clarava™ trial, expected to be announced by the end of June.
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.
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.
First revenues from Tutivia™ following full commercial launch
Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, provides an update on its operational progress made since the release of its interim results in September 2022.
Verici Dx continues to execute the commercial introduction of Tutivia™, the Company’s first product for kidney transplant rejection, with first revenues in FY 2023 and is exploring strategic options to increase sales distribution and launch its second lead product, Clarava™ by the end of the year. The Company retains sufficient funding to achieve further key milestones in 2023 and the first half of 2024, which will support commercial adoption
including the publication of additional data and obtaining both Medicare and private payor pricing and coverage.
Data continues to support product differentiation and competitive advantages Following a robust validation trial using a varied, ‘all-comers’ patient population in a clinical setting, Tutivia™, a post-transplant prognostic test for the assessment of risk of acute kidney rejection, was pilot-launched in December 2022 ahead of its full commercial launch in January 2023. The validation trial data showed a positive predictive value (PPV) of 60%, over three times that was achieved by the closest comparative product in the market when used in the same context, establishing a new industry standard. Additionally, study data analysis of the clinical performance of Tutivia™ demonstrated a differentiation of high-risk and low-risk patient groups, determining that patients of high risk were approximately six times more likely to have a rejection than those of low risk. This represents a significant demonstration of Tutivia TM as a predictive test capable of informing a clear, actionable response from clinicians. The Directors believe that no other comparable products have been validated to this degree.
Tutivia™ also has competitive advantages, as it can be run as early as the first-week post-transplant, earlier than any other test. Tutivia™ enables clinicians to act proactively, rather than reactively, to rejection events, as well as not being confounded by other kidney health complications (such as the BK virus), which need an alternative therapy protocol. This is because Tutivia™ identifies RNA signatures that are specific to acute rejection, as opposed to other tests that detect evidence of damage that may not necessarily be caused by rejection alone.
In addition, following the positive initial data announced in September 2022 on Clarava™, the Company’s pre-transplant prognostic test, the Company chose to expand its validation trial for this lead product for a further six months. This decision was taken to strengthen the publication appeal of the trial and demonstrate a statistically robust and clinically compelling case in support of the commercial rollout and adoption of the test. The full readout from this trial is expected in Q2 2023, with the initial launch expected before the end of the year.
Strong progress on rollout strategy In line with its strategic plan, the Company is working with three leading US transplant centres in the Tutivia™ commercial launch and is supporting them with the adoption and integration of the test into the current clinical pathway, to encourage consistent and recurring utilisation. This is providing a valuable foundation for Verici Dx to make Tutivia™ as simple as possible for clinicians to use and interpret.
Following the successful progression of the Company’s laboratory registration status to Compliance Certification by the Centers for Medicare & Medicaid (‘CMS’), allowing its commercial operation for samples received from patients in 45 US states, Verici Dx is ready to build on the initial rollout activity over the course of 2023. Medicare and Medicaid account nationally for about 65% of all transplant patients and the Company is focused the initial rollout of the test where the proportion of Medicare patients is higher than the national average. To further drive adoption the Company has addressed the pricing and coverage determinations under Medicare. This is administered by the MolDx region of Palmetto given the Company’s laboratory is based in Tennesse. The Company submitted its pricing proposal in Q1 2023 and expects to get the MolDx pricing recommendation by the end of Q2 2023. The Company is currently preparing its submission for Medicare insurance reimbursement coverage, under the Local Coverage Determination (LCD) offered in Palmetto and a coverage determination is expected later this year. Registration for Medicaid has been approved in three states and submitted in a further 11 states as well as with BlueCross Blue Shield of Tennessee, the largest health benefit plan company in the state.
Prudent cash management and execution
As of 31 December 2022, the Company had a cash balance of $9.81m. The Company has taken headcount reduction and clinical trial cost containment steps in recent months and, as a result, has extended the current cash runway to last until mid-2024. The Company is focused on early revenue generation during the first half of this year and will seek to extend and broaden its revenue streams from additional centres in the second half of 2023.
The Company expects to report its preliminary results for the year ended 31 December 2022 by the end of April 2023.
Sara Barrington, CEO of Verici Dx, said:
“We have continued to make significant progress in executing our strategy, resulting in the full commercial launch of Tutivia™ in January, with Clarava’s™ initial launch expected before the end of this year.
“We achieved our internal target of attracting three key, leading US transplant sites as early adopters for
Tutivia™, a critical step that is enabling us to demonstrate the adoption and integration process for clinicians.
“Looking ahead to the rest of the year, we plan to accelerate the rollout of Tutivia™ to other major transplant sites throughout the US, and to secure pricing and health insurance coverage for this lead product. For Clarava™, we expect to report validation shortly and to initiate its initial launch before the end of the year, which will support the collation of further evidence to enable a positive coverage determination. These pivotal milestones will help refine our market positioning and further accelerate commercial uptake of both of our lead products. Verici Dx looks forward to reporting on its further progress.”
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 plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, is aware of public statements and media reports relating to Silicon Valley Bank (“SVB”). The Company does not hold any cash at SVB nor does it have any banking relationship with SVB.
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
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.
The two lead products are Clarava™, a pre-transplant prognosis test for the risk of early acute rejection, and Tutivia™, a post-transplant test focused upon acute cellular rejection, including sub-clinical 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.
Intellectual property portfolio strengthened Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, announces that it has been granted two key patents in the United States that support and protect the Company’s core technologies in RNA signature biomarker tests used for assessment of the prognostic risk pre-transplant (Clarava™) and post- transplant (Tutivia™) of acute kidney transplant rejection. The patents cover broad molecular methods for predicting and diagnosing subclinical and clinical acute rejection, both pre- and post- kidney transplant by algorithmic analysis of gene sets and underpin both of Verici Dx’s lead products, Tutivia™ and Clarava™, and provide protection until 2036 and 2039 respectively. The patents underpinning Tutivia™ have also been previously granted in Europe, China and Australia. These products use a weighted pattern of RNA biomarkers (signature) to assess the risk of rejection by the kidney transplant recipient and to assess rejection earlier and more reliably than other currently available methods. Verici Dx continues to file additional patents reflecting novel refinements to its predictive RNA signatures and methodologies driven by advanced machine learning techniques. The protection of the Company’s intellectual property is fundamental to its strategy of amassing full transcriptomic data from the biological systems and interactions associated with transplant rejection and, over the longer term, informing transplant analysis in other organs and in the broader field of immune-mediated diseases. Sara Barrington, CEO of Verici Dx, said: “Clarava™ and Tutivia™ address a significant unmet need and seek to improve outcomes for kidney transplant patients, by providing early, actionable information for clinicians to inform treatment plans. These significant new patents bolster our intellectual property portfolio and protect our proprietary methods of predicting and diagnosing sub-clinical and clinical acute kidney rejection.”
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.
Successful CMS review and inspection solidify commercial positioning and represents a major milestone toward US Medicare reimbursement
Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, announces that it has successfully progressed its Registration status to Compliance Certification by the Centers for Medicare & Medicaid (“CMS’) for its commercial clinical operations to 45 US states. This follows the inspection by CMS of the Company’s US clinical laboratory based at the Innovation Park in Franklin, Tennessee. The Company now intends to expand commercialisation of its advanced kidney transplant service offerings including Tutivia™. This milestone of certification is also a key requirement to obtaining insurance reimbursement coverage under Medicare under the Local Coverage Determination application being submitted this year. The Company launched its first product, Tutivia™, for the detection of early acute rejection in kidney post-transplant patients, in January 2023. This CLIA certification increases the ease of ordering a Tutivia™ test from laboratories at transplant medical centres and provides further validation of Verici’s tests and services for transplant clinicians across the United States. The Company will now proceed with its plan towards full accreditation in the remaining five states, including New York, which have further compliance requirements. The CLIA certification further exemplifies Verici’s commitment to a quality-focused approach to providing advanced kidney transplant diagnostics services to clinicians and patients in need. Sara Barrington, CEO of Verici Dx, said: “This milestone is an enabling step in our ability to offer our two leading diagnostic tests, Tutivia™ and Clarava™, on a national basis to patients and their clinicians. We are well positioned to achieve additional milestones and progress commercial initiatives in 2023 that will support our growth in the United States.” Verici Dx will give further progress and strategy updates later this month.
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.
