Lead products meet comprehensive requirements at CLIA-certified laboratory, representing an important milestone towards commercialisation
Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, announces that its two lead in vitro diagnostic assays, Clarava™ and Tuteva™, have successfully completed analytical validation under the CLIA1 requirements, meeting comprehensive criteria for robust assay performance. Publication of the study will be made later in the year providing key data to support clinical use.
Analytical validation is an essential element of defining the performance characteristics and platform capabilities of in vitro diagnostic assays, including reproducibility, accuracy, limits of detection, and risk of interferences for any clinician wanting comprehensive data about the reliability of testing. Data collected during analytical validation is essential for the subsequent clinical interpretation of assay results. The process to attain analytical validation is established by regulatory requirements under CLIA1, and its successful completion represents an important milestone towards commercialisation for both Clarava™ and Tuteva™ prior to the results of the clinical validation study expected at the end of Q1 2022.
The analytical validation data also represents a significant milestone in the pathway to reimbursement. Under the Molecular Diagnostic Services Programme (“MolDx”)2, which was developed to identify and provide coverage and reimbursement for molecular diagnostic tests under Medicare, the successful completion and submission of analytical validation studies, in addition to the clinical validation studies, are required for consideration of coverage.
Clarava™ and Tuteva™, are novel, complex RNA expression next-generation sequencing assays coupled with proprietary prediction algorithms, that aim to understand a patient’s pre and post kidney transplant immunologic response. The nature of assay processing for these tests requires specialised expertise that demonstrates precise results and for which all essential performance characteristics are verified.
Michael J. Donovan, Chief Medical Officer, Verici Dx, said: “2022 has started positively for Verici Dx and this latest successful completion of analytical validation is a significant milestone in the pathway to commercialisation, indicating that the performance characteristics and quality design capabilities of our lead tests meet the comprehensive regulatory requirements as set forth by CMS through CLIA.
“We have previously indicated that by the end of this year, the Company will have moved from being solely a Research and Development organisation to one with commercial products, and the important step of analytical validation keeps us on track to do so. A manuscript detailing the key analytical validation data is currently underway, which we look forward to sharing with the clinical community in due course.”
- The Clinical Laboratory Improvement Amendments or CLIA regulate laboratory testing and require clinical laboratories to be certified by the Center for Medicare and Medicaid Services (CMS) before they can accept human samples for diagnostic testing. Verici’s laboratory in Nashville, TN, obtained CLIA certification in July 2021.
- MolDX: Molecular Testing for Solid Organ Allograft Rejection (L38582); available at:
https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=38582&ver=4&bc=0
Enquiries:
Verici Dx is a developer of a complementary suite of leading-edge tests forming a kidney transplant platform for personalized patient and organ response risk to assist clinicians in medical management for improved patient outcomes.
- Tell us about your patient-based focus in the area of kidney transplant.
- Which research underpins your platform? • How does this open up treatment options?
- What does the US designation of laboratory developed tests (LDT) mean for Clarava and Tuteva, and how does the commercialisation strategy differ in other markets?
- Might the technology work for other types of organ transplant?
- What are your licensing and intellectual property strategies?
- Which milestones should investors focus on in the coming year?
Progress and strategy update
Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, announces that CEO Sara Barrington and CFO David Anderson will provide a live progress and strategy update presentation via the Investor Meet Company platform on Tuesday 18 January 2022 at 3:00pm GMT. This follows the recent update announcement released on 12 January 2022.1
The presentation is open to all existing and potential shareholders. Questions can be submitted pre-event via your Investor Meet Company dashboard up until 9am 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.
Notes:
1 https://vericidx.com/progress-and-strategy-update/
Enquiries:
Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, provides the following corporate update for the year ended 31 December 2021.
Verici Dx has continued to make significant progress against the strategic goals set out at IPO in November 2020. The Company has met all key milestones to date, either ahead of time or on schedule, and remains on track for commercial launch of the Company’s two lead products through the Company’s CLIA1 Laboratory in 2022.
The Company’s two leading products, together with a third related product now under development, aim to understand how a patient will respond and is responding to kidney transplantation. The broadened portfolio is poised to offer end-to-end testing for transplant patients and ultimately offer integrated testing information giving a distinct competitive advantage:
- Clarava™ is a pre-transplant prognosis test for the risk of early acute rejection;
- Tuteva™ is a post-transplant test focused upon acute cellular rejection, including sub-clinical rejection as correlates to histopathology findings; and
- Protega™ is a liquid biopsy that aims to predict the risk of fibrosis and long-term graft failure.
Milestone achievements
As previously announced, the Company has passed a number of key milestones over the past twelve months including but not limited to:
| ● | Completion of the testing requirements of the multi-centre validation study for the two lead products, Clarava™ and Tuteva™, before the end of 2021, in-line with expectations;
|
| ● | Additionally, the studies exceeded their enrolment objectives in terms of numbers of sites and participants, assuring a robust data package for analysis and paving the way for efficient clinical validation work on the next study for Protega™;
|
| ● | Verici Dx is on track to conduct a full data analysis and clinical study report for its two lead products, with read-out of key findings in Q1 2022, as planned;
|
| ● | Having accelerated its CLIA1 laboratory opening and approvals strategy, the Company obtained a Certification of Registration from the Centers for Medicare & Medicaid Services (CMS) for its newly established US clinical laboratory in Franklin, Tennessee, ahead of schedule, a significant commercial step at it allows Verici Dx to initiate operations as a diagnostic laboratory;
|
| ● | Receiving, ahead of schedule, the grant from the American Medical Association of CPT® Proprietary Laboratory Analyses codes2,3 for Clarava™ and Tuteva™ which become effective on 1 April 2022 and support the commercial use and tracking of these products within the US healthcare system, including for health insurance purposes;
|
| ● | Extension of the Company’s licence agreement with Mount Sinai to include an additional patent filing related to the analysis of gene expression in a liquid biopsy to predict risk of fibrosis and rejection of the graft over the longer term. This forms the basis of the Company’s Protega™ product and broadens the Verici Dx portfolio;
|
| ● | Agreement to provide access to de-identified patient samples used in the CTOT-19 study4 funded by the National Institutes of Health, to further validate the clinical performance of Clarava™ and Tuteva™ and providing data for an independent publication in 2022. The Company also agreed to provide full transcriptomic sequencing for all patient samples in the study to facilitate further studies and to increase the pace of innovation in transplantation; and
|
| ● | Collaboration with Illumina, Inc. (NASDAQ: ILMN), to expedite the operational launch of data analysis processing and predictive artificial intelligence component of Verici Dx’s products using early access to ICA (Illumina Connected Analytics), a new software platform providing an environment for the clinical testing and further research collaborations arising from these large data sets. |
Outlook
With strong progress on entering 2022, the Company remains focussed on completing validation reporting from the validation study, continuing to accelerate the regulatory and reimbursement pathways needed for commercial launch of Clarava™ and Tuteva™, and to further advancing the work to efficiently validate Protega™. Having already obtained a CPT code, the Company will seek to determine pricing for both of its lead products, and coverage determinations for Clarava™. Tuteva™ is expected to be eligible for and covered by an existing local coverage determination issued by Palmetto under the MolDX system. To support the commercialisation efforts, a health economics model is expected to be completed by the end of Q1 2022, and to engage in clinical utility and real-world evidence studies to support product adoption. Verici Dx expects to accelerate the pathway to coverage determination for Clarava™ through a series of utility training case studies (‘vignettes’) planned for 2022.
The generation of large data sets through the Company’s approach to analysing the whole transcriptome (RNA) will not only support the commercialisation of Verici Dx’s products with the potential to yield further innovation, it is also considered valuable to third parties who may seek income-generating collaborations with the Company in research, therapeutic development including clinical trial enrichment, or longer term studies post approval. The recently announced early-adopter deployment of the Illumina Connected Analytics platform by the Company is expected to be a useful tool in being able to assimilate, analyse and share data with and from such third parties.
Further potential growth opportunities
Verici Dx continues to look for licensing opportunities for complementary new product technologies and tools to expand the Company’s platform and data asset generation. The Company believes there are complementary potential opportunities to add new technology and AI capability to support and enhance the use of Verici Dx product tests alongside histopathology imagery and in the analysis of whole transcriptome and other data.
Notwithstanding the accelerated progress to date, the Company has carefully managed funds to date to deliver an unaudited cash balance of $10.3m at 31 December 2021, in line with expectations after taking into account some deferred capital expenditure which will occur this year. The Company wishes to maintain momentum and take full advantage of the efficiency gains in the initial development work associated with Protega™, as well as planned improvements to the laboratory facilities in Tennessee and the commercial push on ClaravaTM and TutevaTM. Cash resources remain sufficient to continue this expedited progress into early 2023 and Verici Dx will maintain close control of expenditure and prioritise its investments in accordance with its value creation strategy.
The Directors believe that Verici Dx has delivered on the foundation for the longer-term vision to build and leverage its emergent data assets within and beyond kidney transplant into other organs and auto-immune disease, while commercialising the Company’s well-differentiated core products and capabilities.
Sara Barrington, CEO, commented:
“2022 is set up to be another exciting year for Verici Dx and by the end of the year the Company will have firmly moved from being a Research and Development organisation to one with commercial products. Our products have strong differentiation and our ambition is to create a compelling platform for clinicians to use as they seek to improve and optimise attainable outcomes. With the expansion of our product portfolio to cover fibrosis, we aim to address the patient’s pre- and post-transplant journey and to bring further understanding and innovation to healthcare challenges in transplant and other immune-mediated areas. We look forward to a productive year of further progress.”
An updated Corporate Presentation, including a summary of the Company’s anticipated development and commercialisation timeline, will be made available online later today at the following location: https://vericidx.com/investors/documents-and-presentations/
Notes:
| 1 | Clinical Laboratory Improvement Amendments (CLIA) Certification of Registration under the Centers for Medicare & Medicaid Services (CMS) |
| 2 | Current Procedural Terminology (CPT) codes are medical codes that are used to report medical, surgical, and diagnostic procedures and services to entities such as physicians, health insurance companies and accreditation organizations. CPT codes are also used for administrative management purposes such as claims processing and developing guidelines for medical care review. |
| 3 | PLA codes are CPT codes including a corresponding descriptor for laboratories or manufacturers that want to identify their test more specifically. |
| 4 | 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. |
Enquiries:
Primary data analysis of two lead products on track for Q1 2022 read-out
Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, announces that its two leading products have completed the testing requirements of the multi-centre validation study, in line with the Company’s expectations to have done so by the end of 2021. Reaching the clinical endpoints of the study means that, for both products, sufficient numbers of participants have completed the required follow-up to outcomes assessment, including biopsy findings, which are required for the full data analysis and clinical study report to be conducted in Q1 2022, as per the Company’s targets.
The Company’s two leading products aim to understand how a patient will and is responding to kidney transplantation:
- Clarava™ is a pre-transplant prognosis test for the risk of early acute rejection; and
- Tuteva™ is a post-transplant test focused upon acute cellular rejection, including sub-clinical rejection as correlates to histopathology findings.
Verici Dx has partnered with fourteen leading US, Australian and EU centres in its collaborative, multi-centre clinical validation study. As previously announced, patient enrolment for both Clarava and Tuteva performance evaluation was completed ahead of schedule in August 2021, and we are grateful to all of the participating sites and their clinical teams for achieving this. The extent of commitment shown by these leading centres is testament to the recognition of the robust, scientific approach being taken by Verici Dx to its data gathering and analysis, and to the shared desire to make much-needed and potentially very significant gains in transplant patient outcomes.
As announced on 11 January 2021, Verici Dx in-licensed additional intellectual property (IP) relating to gene expression in a blood-based test (liquid biopsy) to predict the risk of fibrosis or chronic kidney graft damage. This is being commercialised under the product name, ProtegaTM and extends the Verici Dx portfolio across the full transplant patient journey by focusing on the prognosis of longer-term graft failure. Protega™ augments the Company’s portfolio into an end-to-end transplant testing suite, from pre-transplant and short-term post-transplant to also include later-stage risk assessment.
The current fourteen clinical trial sites participating in the validation study for Clarava™ and Tuteva™ will continue the enrolment of patients for an extended period for the validation study of Protega and is expected to reach target by the end of Q3 next year. The potential to inform earlier clinical interventions with treatments such as anti-fibrotic therapies ahead of irreversible organ damage is another key step to improving transplant outcomes.
Patti Connolly, Executive VP, Product Development of Verici Dx, said: “We are pleased that both Clarava™ and Tuteva™ have not only exceeded the enrolment objectives for the clinical validation study in terms of numbers of sites and participants, but also completed testing in line with our expectations. This is another step towards the commercialisation of our two lead products, and we look forward to the data analysis and reporting of key findings in Q1 2022, with additional analyses to follow.
“I’d like to extend Verici Dx’s gratitude to all of the kidney transplant patients participating in our studies as well as thanks to our fourteen collaborating centres across the US, Australia and EU who have partnered with us to bring these innovative in vitro diagnostics closer to the clinic. We look forward to sharing the validation reporting in 2022 as we approach commercial readiness for our two lead products and continue with validation for our third product.”
Enquiries:
Readiness for launch, accelerated by Illumina Connected Analytics (ICA), represents an important milestone in the path to commercialization of Verici Dx’s lead products
Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, announces a pioneering collaboration with Illumina, Inc. (NASDAQ: ILMN), to expedite the operational launch of data analysis processing and predictive artificial intelligence component of Verici Dx’s products using early access to ICA, Illumina’s new software platform for operationalized secondary analysis with an advanced data science environment.
Verici Dx’s underlying technology is based upon artificial intelligence assisted transcriptomic analysis of proprietary RNA signatures focused upon the immune response and other biological pathway signals critical for transplant prognosis of risk of injury, resulting in rejection and graft failure beginning pre-transplant and following to late-stage.
ICA will provide Verici Dx with the ability to process large datasets, allowing for AI-enabled RNA signature testing to be clinically available at a more robust level than has been previously possible. ICA also enables Verici Dx to build custom workflows in a secure and compliant environment. With streamlined querying of large data sets, ICA supports Verici Dx’s leading-edge technology and provides a framework for future data science discovery. ICA allows the integration of Illumina sequencers and software in a cloud-based environment and is accessible globally enabling further expansion and collaboration opportunities for Verici Dx.
Having access to this state-of-the-art platform provides a substantial enhancement to Verici Dx’s data management and interrogation capabilities and bolsters its ability to develop highly predictive future products. It will also enable Verici Dx to stay at the forefront of improving patient outcomes.
Susan Tousi, Chief Commercial Officer of Illumina, said: “We are pleased to collaborate with Verici Dx to provide a platform for them to advance their sequencing analytical methodologies for organ transplant tests. Looking towards the future of Illumina’s software portfolio, Illumina Connected Analytics is the foundation upon which we are building to get data-driven answers.”
Sara Barrington, CEO of Verici Dx, said: “We are delighted to announce the successful operational launch of the Verici Dx data analysis processing and predictive artificial intelligence components of our clinical products as inaugural users of Illumina’s new ICA platform. Our leading-edge science depends on the ability to process vast amounts of data into meaningful and interpretable segments, and we believe there is no better tool to support us in this than ICA. We are very proud to be an early-access user of this tool in the commercial space from a world-class provider and leader in servicing the global sequencing market.
“This milestone represents a key step in the readiness of both the near-term launches of our flagship Clarava™ and Tuteva™ products, as well as the long-term strategy for building the computational data analytics tools that will power the future of Verici Dx’s data science. We look forward to updating the market with our further progress towards commercialization in due course.”
Enquiries:
CPT Codes facilitate reimbursement and represent first milestone on pathway to commercialisation
Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, announces it has been granted CPT® Proprietary Laboratory Analyses (“PLA”) codes
1,2 for both its Clarava and Tuteva tests by the American Medical Association (“AMA”). The new codes have been approved and published by the AMA Editorial Panel and are scheduled to become effective on April 1, 2022.
Patti Connolly, Executive VP, Product Development of Verici Dx, said: “We were delighted with the AMA’s decision as CPT® codes are fundamental in the commercialisation of our lead products.”
Reimbursement in the US is comprised of three components: code, price and coverage. CPT® codes offer health care professionals a uniform language for coding medical services and procedures, and the CPT® PLA code allows clinical laboratories to more specifically identify their tests when billing Medicare and commercial insurers. The successful granting of a CPT® code marks the first step on the path for commercial reimbursement.
Notes:
- Current Procedural Terminology (CPT) codes are medical codes that are used to report medical, surgical, and diagnostic procedures and services to entities such as physicians, health insurance companies and accreditation organizations. CPT codes are also used for administrative management purposes such as claims processing and developing guidelines for medical care review.
- PLA codes are CPT codes including a corresponding descriptor for laboratories or manufacturers that want to identify their test more specifically.
Enquiries:
About The American Society of Nephrology
Since 1966, ASN has been creating a world without kidney diseases by educating and informing, driving breakthroughs and innovation, and advocating for policies that create transformative changes in kidney medicine throughout the world. ASN has more than 21,000 members representing 131 countries. For more information, visit www.asn-online.org.
1. Issuer Details
ISIN: GB00BM8HZD43
Issuer Name: VERICI DX PLC
UK or Non-UK Issuer: UK
2. Reason for Notification
An acquisition or disposal of voting rights
3. Details of person subject to the notification obligation
Name
Harwood Capital Management (Gibraltar) Limited
City of registered office (if applicable)
Gibraltar
Country of registered office (if applicable)
Gibraltar
| Name | City of registered office | Country of registered office |
| Harwood Capital LLP | London | United Kingdom |
4. Details of the shareholder
| Name | City of registered office | Country of registered office |
| Oryx International Growth Fund Limited | St Peter Port | Guernsey |
| North Atlantic Smaller Companies Investment Trust plc | London | United Kingdom |
| Harwood Capital LLP | London | United Kingdom |
5. Date on which the threshold was crossed or reached
16-Dec-2021
6. Date on which Issuer notified
17-Dec-2021
7. Total positions of person(s) subject to the notification obligation
| . | % of voting rights attached to shares (total of 8.A) | % of voting rights through financial instruments (total of 8.B 1 + 8.B 2) | Total of both in % (8.A + 8.B) | Total number of voting rights held in issuer |
| Resulting situation on the date on which threshold was crossed or reached | 20.010000 | 0.000000 | 20.010000 | 28368572 |
| Position of previous notification (if applicable) |
8. Notified details of the resulting situation on the date on which the threshold was crossed or reached
8A. Voting rights attached to shares
| Class/Type of shares ISIN code(if possible) | Number of direct voting rights (DTR5.1) | Number of indirect voting rights (DTR5.2.1) | % of direct voting rights (DTR5.1) | % of indirect voting rights (DTR5.2.1) |
| GB00BM8HZD43 | 5500000 | 3.880000 | ||
| GB00BM8HZD43 | 16500000 | 11.640000 | ||
| GB00BM8HZD43 | 6368572 | 4.490000 | ||
| Sub Total 8.A | 28368572 | 20.010000% | ||
8B1. Financial Instruments according to (DTR5.3.1R.(1) (a))
| Type of financial instrument | Expiration date | Exercise/conversion period | Number of voting rights that may be acquired if the instrument is exercised/converted | % of voting rights |
| Sub Total 8.B1 | ||||
8B2. Financial Instruments with similar economic effect according to (DTR5.3.1R.(1) (b))
| Type of financial instrument | Expiration date | Exercise/conversion period | Physical or cash settlement | Number of voting rights | % of voting rights |
| Sub Total 8.B2 | |||||
9. Information in relation to the person subject to the notification obligation
Full chain of controlled undertakings through which the voting rights and/or the financial instruments are effectively held starting with the ultimate controlling natural person or legal entities (please add additional rows as necessary)
| Ultimate controlling person | Name of controlled undertaking | % of voting rights if it equals or is higher than the notifiable threshold | % of voting rights through financial instruments if it equals or is higher than the notifiable threshold | Total of both if it equals or is higher than the notifiable threshold |
| Christopher Harwood Bernard Mills | Oryx International Growth Fund Limited | 3.880000 | ||
| Christopher Harwood Bernard Mills | North Atlantic Smaller Companies Investment Trust plc | 11.640000 | ||
| Christopher Harwood Bernard Mills | Harwood Capital LLP | 4.490000 |
10. In case of proxy voting
Name of the proxy holder
–
The number and % of voting rights held
–
The date until which the voting rights will be held
–
11. Additional Information
–
12. Date of Completion
17-Dec-2021
13. Place Of Completion
London Stock Exchange
