Close of Accelerated Bookbuild

Further to the announcement made at 7.10 a.m. today, the Placing has now closed and the Bookbuild has been successfully concluded. The Subscription will remain open until further notice to allow a limited number of entities and individuals who are outside of the United Kingdom to subscribe.

Participants in the Placing will be contacted by Singer Capital Markets as soon as practicable today to confirm their allocations once finalised. A further announcement will be made in due course confirming details of the Fundraise.

Capitalised terms used in this announcement shall, unless defined in this announcement or unless the context provides otherwise, bear the same meaning ascribed to such terms in the announcement made by the Company at 7.10 a.m. today to announce the launch of the Fundraise.

Enquiries:

IMPORTANT NOTICES

This Announcement and the information contained herein is for information purposes only and is not for release, publication or distribution, directly or indirectly, in whole or in part, in or into or from the United States, Australia, Canada, Japan, New Zealand, the Republic of South Africa, or any other jurisdiction where to do so might constitute a violation of the relevant laws or regulations of such jurisdiction (the “Placing Restricted Jurisdictions“). The New Ordinary Shares have not been and will not be registered under the United States Securities Act of 1933 (the “Securities Act“) or under the securities laws of any state or other jurisdiction of the United States and may not be ordered, sold, or transferred, directly or indirectly, in or into the United States absent registration under the Securities Act or an available exemption from or in a transaction not subject to the registration requirements of the Securities Act and, in each case, in compliance with the securities law of any state or any other jurisdiction of the United States. No public offering of the New Ordinary Shares is being made in the United States. Persons receiving this Announcement (including custodians, nominees and trustees) must not forward, distribute, mail or otherwise transmit it in or into the United States or use the United States mails, directly or indirectly, in connection with the Fundraising. This Announcement does not constitute or form part of an order to sell or issue or a solicitation of an order to buy, subscribe for or otherwise acquire any securities in any jurisdiction including, without limitation, the Placing Restricted Jurisdictions or any other jurisdiction in which such order or solicitation would be unlawful. This Announcement and the information contained in it is not for publication or distribution, directly or indirectly, to persons in a Placing Restricted Jurisdiction unless permitted pursuant to an exemption under the relevant local law or regulation in any such jurisdiction.

No action has been taken by the Company, Singer Capital Markets or any of their respective directors, officers, partners, agents, employees or affiliates that would permit an offer of the New Ordinary Shares or possession or distribution of this Announcement or any other publicity material relating to such New Ordinary Shares in any jurisdiction where action for that purpose is required.

Persons receiving this Announcement are required to inform themselves about and to observe any restrictions contained in this Announcement. Persons (including, without limitation, nominees and trustees) who have a contractual or other legal obligation to forward a copy of this Announcement should seek appropriate advice before taking any action.

This Announcement is not being distributed by, nor has it been approved for the purposes of section 21 of FSMA by, a person authorised under FSMA. This Announcement is being distributed and communicated to persons in the United Kingdom only in circumstances in which section 21(1) of FSMA does not apply.

The information contained in this Announcement is for background purposes only and does not purport to be full or complete. No reliance may be placed for any purpose on the information contained in this Announcement or its accuracy, fairness or completeness.

Any indication in this Announcement of the price at which the Company’s shares have been bought or sold in the past cannot be relied upon as a guide to future performance. Persons needing advice should consult an independent financial adviser. No statement in this Announcement is intended to be a profit forecast and no statement in this Announcement should be interpreted to mean that earnings per share of the Company for the current or future financial years would necessarily match or exceed the historical published earnings per share of the Company.

Singer Capital Markets, which is authorised and regulated in the United Kingdom by the FCA, is acting as broker and bookrunner exclusively to the Company and to no-one else in connection with the Placing and Admission and will not be responsible to anyone (including any Placees) other than the Company for providing the protections afforded to its clients, nor for providing advice in relation to the Placing or Admission or any other matters referred to in this Announcement.

Singer Capital Markets Advisory LLP, which is authorised and regulated in the United Kingdom, is acting as nominated adviser to the Company for the purposes of the AIM Rules in connection with the Placing and Admission and to no-one else in connection with the Placing and Admission and will not be responsible to any person other than the Company for providing the protections afforded to its clients, nor for providing advice in relation to the Placing or Admission or any other matters referred to in this Announcement. Singer Capital Markets Advisory LLP’s responsibilities as the Company’s nominated adviser under the AIM Rules and the AIM Rules for Nominated Advisers are owed solely to the London Stock Exchange and are not owed to the Company, any director of the Company or to any other person in respect of his decision to acquire shares in the capital of the Company in reliance on any part of this Announcement or otherwise.

This Announcement has been issued by and is the sole responsibility of the Company. No representation or warranty, express or implied, is or will be made as to, or in relation to, and no responsibility or liability is or will be accepted by or on behalf of the Company (except to the extent imposed by law or regulations), Singer Capital Markets or by their affiliates or their respective agents, directors, officers and employees as, or in relation, to the contents of this Announcement, including its accuracy, completeness or verification or for any other statement made or purported to be made by any of them, or on their behalf, the Company or any other person in connection with the Company, the Fundraising or Admission or for any other written or oral information made available to or publicly available to any interested party or its advisers, and any liability therefore is expressly disclaimed. Singer Capital Markets and its affiliates and agents disclaims to the fullest extent permitted by law all and any responsibility or liability whatsoever, whether arising in tort, contract or otherwise, which it might otherwise have in respect of this Announcement or any such statement.

The New Ordinary Shares will not be admitted to trading on any stock exchange other than to trading on AIM.

Neither the content of the Company’s website (or any other website) nor the content of any website accessible from hyperlinks on the Company’s website (or any other website) is incorporated into, or forms part of, this Announcement.

Cautionary statements

This Announcement may contain and the Company may make verbal statements containing “forward-looking statements” with respect to certain of the Company’s plans and its current goals and expectations relating to its future financial condition, performance, strategic initiatives, objectives and results. Forward-looking statements sometimes use words such as “aim”, “anticipate”, “target”, “expect”, “estimate”, “intend”, “plan”, “goal”, “believe”, “seek”, “may”, “could”, “outlook” or other words of similar meaning. By their nature, all forward-looking statements involve risk and uncertainty because they relate to future events and circumstances which are beyond the control of the Company. As a result, the actual future financial condition, performance and results of the Company may differ materially from the plans, goals and expectations set forth in any forward-looking statements. Any forward-looking statements made in this Announcement by or on behalf of the Company speak only as of the date they are made. The information contained in this Announcement is subject to change without notice and except as required by applicable law or regulation (including to meet the requirements of the AIM Rules, MAR, the Prospectus Regulation and/or FSMA), the Company expressly disclaims any obligation or undertaking to publish any updates or revisions to any forward-looking statements contained in this Announcement to reflect any changes in the Company’s expectations with regard thereto or any changes in events, conditions or circumstances on which any such statements are based. Such forward-looking statements involve risks and uncertainties that could significantly affect expected results and are based on certain key assumptions. Many factors could cause actual results, performance or achievements to differ materially from those projected or implied in any forward-looking statements. The important factors that could cause the Company’s actual results, performance or achievements to differ materially from those in the forward-looking statements include, among others, economic and business cycles, the terms and conditions of the Company’s financing arrangements, foreign currency rate fluctuations, competition in the Company’s principal markets, acquisitions or disposals of businesses or assets and trends in the Company’s principal industries. Statements contained in this Announcement regarding past trends or activities should not be taken as representation that such trends or activities will continue in the future. You should not place undue reliance on forward-looking statements, which speak only as of the date of this Announcement.

No statement in this Announcement is intended to be a profit forecast and no statement in this Announcement should be interpreted to mean that earnings per share of the Company for the current or future years would necessarily match or exceed the historical published earnings per share of the Company.

This Announcement does not identify or suggest, or purport to identify or suggest, the risks (direct or indirect) that may be associated with an investment in the Placing Shares. Any investment decisions to buy Placing Shares in the Placing must be made solely on the basis of publicly available information, which has not been independently verified by SCM.

This Announcement does not constitute a recommendation concerning any investor’s investment decision with respect to the Placing. The price of shares and any income expected from them may go down as well as up and investors may not get back the full amount invested upon disposal of the shares. Past performance is no guide to future performance. The contents of this Announcement are not to be construed as legal, business, financial or tax advice. Each investor or prospective investor should consult his, her or its own legal adviser, business adviser, financial adviser or tax adviser for legal, financial, business or tax advice.

In connection with the Placing, SCM and its respective partners, directors, officers, employees, advisers, consultants, affiliates or agents may take up a portion of the shares of the Company in the Placing in a principal position and in that capacity may retain, purchase or sell for its own account such shares and other securities of the Company or related investments and may offer or sell such shares, securities or other investments otherwise than in connection with the Placing. Accordingly, references in this Announcement to Placing Shares being issued, offered or placed should be read as including any issue, offering or placement of such shares in the Company to SCM and any of its respective partners, directors, officers, employees, advisers, consultants, affiliates or agents as, acting in such capacity. In addition, SCM and any of its respective partners, directors, officers, employees, advisers, consultants, affiliates or agents may enter into financing arrangements (including swaps, warrants or contracts for difference) with investors in connection with which SCM and any of its respective partners, directors, officers, employees, advisers, consultants, affiliates or agents may from time to time acquire, hold or dispose of such securities of the Company, including the Placing Shares. Neither SCM nor any of its respective partners, directors, officers, employees, advisers, consultants, affiliates or agents intends to disclose the extent of any such investment or transactions otherwise than in accordance with any legal or regulatory obligation to do so.

The Placing Shares to be issued and/or purchased pursuant to the Placing will not be admitted to trading on any stock exchange other than AIM, a market operated by the London Stock Exchange plc.

Neither the content of the Company’s website (or any other website) nor the content of any website accessible from hyperlinks on the Company’s website (or any other website) is incorporated into or forms part of this Announcement.

This Announcement has been prepared for the purposes of complying with applicable law and regulation in the United Kingdom and the information disclosed may not be the same as that which would have been disclosed if this Announcement had been prepared in accordance with the laws and regulations of any jurisdiction outside the United Kingdom.

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Proposed Placing launch via accelerated bookbuild (ABB) and direct Subscription
Definitions contained within Appendix II to this Announcement apply unless the context otherwise requires

Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, announces its intention to conduct a fundraise through the non pre-emptive issue of at least 28,571,429 new ordinary shares at a price of 35 pence per share (the “Fundraise Price”), to raise gross proceeds for the Company of at least £10.0 million (approximately $13.3 million) (the “Fundraise”).

The Fundraise will comprise a non-pre-emptive placing with institutional and other investors (the “Placing”) and a direct subscription with a limited number of entities and individuals who are outside of the United Kingdom (the “Subscription”).

The Fundraise Price of 35 pence represents a discount of 6.67 per cent. to Verici’s closing mid-price on 3 March 2022 (being the last practicable day prior to the publication of this Announcement).

Transaction Highlights

The Company intends to use the net proceeds of the Fundraise to take advantage of the opportunities outlined in the Progress and Strategy announcement released on 12 January 2022 and continue the accelerated progress the Company has experienced to date.

As of 31 December 2021, the Company had unaudited net cash of £7.7 million ($10.3 million).  The net proceeds of the Fundraise will be used, together with the Company’s existing available resources, to:

• Maintain momentum on the development of the Company’s third product, Protega™, to maximise the efficiency gains in using existing validation sites set up for the Company’s two lead products, Clarava™ and Tuteva™;
• Carry out planned construction of the Company’s expanded CLIA approved laboratory facilities in Tennessee to support the scale-up of business operations in advance of commercialisation;
• Accelerate the commercialisation of lead products Clarava™ and Tuteva™ through advocacy with clinicians;
• Explore potential growth opportunities including adding new technology (including possible in-licence or acquisition) and Artificial Intelligence (“AI”) capability to support and enhance the use of Verici Dx product tests alongside digital histopathology imagery;
• Develop the Company’s nascent data assets; and
• Support general working capital purposes.

The Placing Shares are being offered, subject to the satisfaction of certain conditions set out in the Appendix to this announcement, by way of an accelerated bookbuild (the “Bookbuild”) which will be launched immediately following this Announcement. Singer Capital Markets Securities Limited (“Singer Capital Markets“) is acting as the sole bookrunner in connection with the Placing.

The Placing, which is conditional on, amongst other things, Admission, is being carried out within the Company’s existing shareholder authority to issue shares on a non pre-emptive basis. The number of Placing Shares will be agreed by the Company in conjunction with the bookrunner following the close of the Bookbuild to further orders, and the results of the Placing will be announced as soon as practicable thereafter. The timing of the closing of the book, acceptance of any orders received after a close of Bookbuild announcement, final allocations and the total size of the Placing shall be determined at the absolute discretion of the Company and the bookrunner. The Placing is not conditional upon the Subscription and is likely to complete before the Subscription is closed. The Fundraise will not in any event involve the issue of more than 35,436,954 new ordinary shares, being the maximum limit under the Company’s existing authority to allot shares on a non pre-emptive basis. Neither the Placing nor the Subscription is being underwritten.

As part of the Placing, the Company is seeking to raise funds by the issue of Placing Shares to Venture Capital Trusts (“VCTs”) and investors seeking tax relief under the Enterprise Investment Scheme (“EIS”) (together the “EIS/VCT Placing Shares”) (the “EIS/VCT Placing”). The raising of funds via the issue of the balance of the Placing Shares is referred to herein as the “Non-EIS/VCT Placing”.

The EIS/VCT Placing Shares to be issued pursuant to the First Placing are intended to rank as “eligible shares” for the purposes of EIS and VCT investors and a “qualifying holding” for the purposes of an investment by VCTs, each pursuant to the relevant respective sections of the Income Tax Act 2007 (“ITA 2007”). The Company has not made an advanced assurance application to HM Revenue & Customs (“HMRC”) in respect of EIS qualification of this Placing, but the Company has obtained a written opinion from specialist tax advisers confirming that the Company would, subject to the relevant limits on such issuances, be able to issue the EIS/VCT Placing Shares as “eligible shares” under the relevant sections of the ITA 2007. Neither the Company nor the Directors give any warranties or undertakings that EIS reliefs or VCT reliefs will be granted in respect of the EIS/VCT Placing Shares. Neither the Company nor the Directors give any warranties or undertakings that EIS reliefs or VCT reliefs, if granted, will not be withdrawn. If the Company carries on activities beyond those disclosed to HMRC in a prior advance clearance, then shareholders may cease to qualify for the tax benefits. Placees must take their own advice and rely on it.

The allotment and issue of the EIS/VCT Placing Shares is not conditional upon completion of the Non-EIS/VCT Placing, which is conditional upon Admission and, once made, such allotments under the EIS/VCT Placing will remain valid regardless of whether -Admission occurs and the Non-EIS/VCT Placing completes.

Expected Timetable of Principal Events

 Each of the times and dates above refer to London time and are subject to change. Any such change will be notified to Shareholders by an announcement through a Regulatory Information Service.

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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.”

1. 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.
2. 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:

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 Clarava^TM and Tuteva^TM. 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:

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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, Protega^TM 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: