YGEN.L Regulatory News (YGEN)

Concepta PLC

("Concepta" or the "Company")

Launch of genomic testing service MyHealthChecked

First test available will be for the detection of COVID-19

Proposed change of name to MyHealthChecked Plc

Concepta PLC (AIM: CPT), the personalised healthcare company, announces the launch of its DNA testing service, following the recent acquisition of The Genome Store. The testing service will be launched today under the new MyHealthChecked™ brand and the first test swab kit available will be a fast and reliable direct to consumer COVID-19 lab-based PCR test available to the UK public via a new ecommerce website.

The MyHealthChecked™ COVID-19 testing service will use the Clarigene® SARS-CoV-2 test supplied by Yourgene Health plc (AIM: YGEN) and the PrimeStore® MTM sample collection device supplied by EKF Diagnostic Holdings plc (AIM: EKF). The MyHealthChecked™ testing service allows samples to be quickly and conveniently taken at home using simple nasal collection swabs which are then sent via free postage for processing using established laboratory-based DNA and RNA detection methods.

The newly acquired team has delivered the launch of this COVID-19 testing service to an efficient timescale, enabling an awareness drive to the public ahead of the Christmas period at a time when members of the public are making holiday plans. The Company expects to launch a number of DNA tests covering a range of female and male wellness, food intolerance and lifestyle testing, and further develop a pipeline of tests from Q1 2021. MyHealthChecked™ will offer consumers a range of simple to use DNA tests across key healthcare areas, and target pricing affordably to improve accessibility for the public.

Penny McCormick, Chief Executive Officer of Concepta plc, said: "As our pipeline development continues and we invest in our plans to build a sustainable, long term business, we're proud to be delivering on this short-term opportunity with a high quality, highly accurate coronavirus swab kit and testing service. Our priority is to look beyond the pandemic with a range of affordable, meaningful at-home test kits, but it would be remiss of us - now with the expertise and operational channel in-house - not to make this kit available to the public." 

As the government welcomes news on the future arrival of vaccines, the requirement for at home testing kits is expected to continue. Last week the Transport Secretary announced a new testing scheme from 15 December for people travelling into England from overseas destinations, advising that the purchase of a private test and a negative coronavirus result could reduce quarantine periods by more than half.

Ms McCormick commented: "The government is providing clear guidelines and instructions regarding international travel, and the meeting of familial and friendship groups over Christmas, and people are sensibly deciding to what level they wish to operate within that framework. We fully support the government's testing programme, whilst providing a solution for those who wish to test independently for requirements like travel, or for personal reasons."

Proposed change of name to MyHealthChecked Plc

In addition, the Company also confirms that it will change its name to MyHealthChecked™ Plc. Trading in the Company's shares on the AIM market of the London Stock Exchange under the new name is expected to take effect in due course and the Company's stock exchange ticker is also expected to change from CPT to MHC. The Company will announce when this is effected. At that time the Company's website will change to:

www.myhealthcheckedplc.com

Related Party Transactions

The entering into an agreement to use the Clarigene® SARS-CoV-2 test as supplied by Yourgene Health plc, of which both Adam Reynolds (Chairman) and Lyn Rees (Non-Executive Director) are Directors, has been treated as a related party transaction. Product pricing for the agreement has been prepared on an arm's-length basis and there is no minimum volume requirement. Having consulted with SPARK Advisory Partners Limited, the Independent Directors (those directors other than Messrs Reynolds and Rees) consider that the terms of the agreement are fair and reasonable insofar as Shareholders are concerned.

In addition, initial purchase orders (of £16,500) have been placed with EKF Diagnostic Holdings plc ("EKF") for PrimeStore® MTM sample collection devices. Adam Reynolds is also a Director of EKF and this order has been treated as a related party transaction. Product pricing for the agreement has been prepared on an arm's-length basis and there is no minimum volume requirement. Having consulted with SPARK Advisory Partners Limited, the Independent Directors (those directors other than Mr Reynolds) consider that the terms of the order are fair and reasonable insofar as Shareholders are concerned.

About the Clarigene™ SARS-CoV-2 test

The Clarigene™ SARS-CoV-2 CE-IVD test is a RT-qPCR ("real-time quantitative polymerase chain reaction") assay which detects the presence of SARS CoV-2 viral RNA*. The assay uses two viral RNA targets which are SARS-CoV-2 specific preventing cross reactivity and providing a more reliable result. Clinical validation of the test has shown >99.9% accuracy with no false positive or false negative results. Additional studies have shown 100% repeatability data and an average >99.7% reproducibility.

About the PrimeStore MTM COVID-19 sample collection device

The PrimeStore MTM sample collection device deactivates the SARS-CoV-2 virus and stabilises the RNA for transport with no requirement for cold storage. In a recent study published by Public Health England PrimeStore MTM was the only commercially available CE-marked and Food & Drug Administration ("FDA") cleared transport media.

About Concepta PLC (www.conceptaplc.com)

Concepta PLC, based in Cardiff, is an AIM-quoted pioneering UK healthcare company with two diverse, customer-facing at-home testing brands in its portfolio:

MyHealthChecked is the umbrella brand of a range of at-home DNA and RNA tests, now in development following the recent acquisition of The Genome Store. The tests will be made available on line, and would be viable for over the counter purchase.

The MyHealthChecked portfolio has been identified as part of a change in mindset as customers become more familiar with the concept of accessible healthcare in the growing at home testing kit market with a focus on accessibility at the right price, led by UK-based experts.

Mylo targets the personalized mobile health market, with a primary focus on hormone testing and increasing a woman's chances of naturally getting pregnant, and providing insight to unexplained infertility. MYLO is a CE-marked IVD expected to be beneficial to users who have been unable to conceive after 6 months of trying. This highly motivated target group of women won't typically be offered medical intervention until after 12 months of unsuccessfully trying to conceive, with IVF not usually offered until after two years of trying to conceive. Research indicates couples start to take positive action ahead of this time typically with little medical support to help them do so.

MYLO is currently the UK's only consumer product which allows both quantitative and qualitative home (self-test) test measurement of a woman's personal luteinizing hormone (LH) during ovulation and human chorionic gonadotropin ("hCG") hormone level during pregnancy.