Monday 20 April 2020
Here is our summary of the day's hottest RNS alerts from across London's Alternative Investments Market (AIM).
Yourgene Health Plc (YGEN.L)
Year-end Trading update: Revenues increase 86%
Revenues for the year ended 31 March 2020 were £16.6m (2019: £8.9m), up 86% compared to the previous year, and does not include £0.4m of orders for March that fell into the new financial year due to COVID-19 transport restrictions. The revenue increase reflects organic growth of approximately 36%; 11 months contribution from Elucigene Diagnostics, acquired on 26 April 2019; and three weeks' contribution from the Company's French NIPT distribution business, acquired on 10 March 2020.
Revenues by region
The strong growth across all regional segments shown below demonstrates the Company's diversified geographic base. Despite the disruptions caused by the spread of COVID-19, our customers in Europe are continuing to operate as normal, albeit with some slight timing delays if and where there are localised staffing or logistics issues. The integration of the French distribution business is also progressing to plan.
Our core South East Asian markets have so far been very successful in containing the virus and avoiding restrictive practices which might have otherwise inhibited our business there. Travel disruption has had an impact on our launch in the US, where we do not have local teams in place yet, and whilst we are recording our first revenues in this key market, we do expect further orders to be fulfilled in the new financial year.
Revenues by product
Global sales of non-invasive prenatal testing (NIPT) products and services grew at 29% and this is whilst UK and Europe customers wait to transition to our Illumina-based IONA® test, for which we are awaiting regulatory approval during the first quarter of the new financial year. Preparations for the product launch are well advanced and will commence as soon as regulatory approval is obtained and COVID-19 restrictions permit.
During the year to 31 March 2020 we have successfully broadened our portfolio beyond NIPT with 22% of sales now derived from reproductive health products and 17% derived from the Company's rapidly growing Oncology & Research Services activities in Asia.
Whilst the impact of COVID-19 in the final quarter was a major challenge the Company still delivered a strong end to the year. Yourgene has in place robust systems to continue to operate efficiently and to provide customers with world-leading molecular diagnostic solutions and services. In addition, as announced on 25 March 2020, the Company signed a contract manufacturing agreement withNovacyt S.A. ("Novacyt") to support the production of COVID-19 diagnostic tests developed by Primerdesign, Novacyt's molecular diagnostics division. The contribution from this partnership has started to crystallise in the new financial year with our first shipments now successfully completed.
Omega Diagnostics (ODX.L)
COVID-19 MTA signed with Mologic Ltd
Omega, the medical diagnostics company focused on CD4, infectious diseases, food intolerance and allergy testing, announced that it has signed a Material Transfer Agreement ("MTA") with Mologic Ltd to formalise a partnership to provide manufacturing capability for Mologic's COVID-19 first generation ELISA1 diagnostics test, the development of which has been funded in part by the UK government. Once ready, the antibody test will be capable of playing a key part towards identifying people that have built up immunity to coronavirus.
Omega has provided Mologic with access to one of its manufacturing facilities (which specialises in manufacturing ELISA tests), situated in Littleport, Cambridgeshire, England and both parties have collaborated to produce pilot batches and first validation batches.
The MTA formalises Omega's access to raw materials and know-how to manufacture Mologic's diagnostic test at scale, using Omega's ELISA manufacturing facility in Littleport.
Following successful independent validation of Mologic's ELISA test by the Liverpool School of Tropical Medicine and St George's, University of London, Mologic has now submitted its test to Public Health England and NHS Scotland for formal validation. Once validated, Omega and Mologic will enter into a longer-term supply agreement with Omega manufacturing up to 46,000 COVID-19 tests per day.
Omega will also CE Mark the test under the MTA, after which both parties will work together to commercialise the test.
Genedrive Plc (GDR.L)
Cytiva collaboration on Coronavirus PCR Test
Genedrive plc, the near patient molecular diagnostics company, announces it has entered into an agreement with Cytiva (formerly GE Healthcare Life Sciences) for the development of its Genedrive® 96 SARS-CoV-2 assay for use on lab-based PCR instruments. This is one of two assay programmes the Company is developing following an announcement made on 25 March 2020.
The Genedrive® 96 SARS-CoV-2 assay combines Genedrive's PCR chemistry integrated with Cytiva's LyoStable® stabilisation technology. The combination would allow for high throughput manufacturing of over 10,000 tests per hour in a 96-well, temperature-stable plate format that could be transported globally without the need for refrigeration. The one-step test features a single PCR bead that once mixed with a patient's sample, can be performed on a variety of existing open PCR platforms from manufactures such as Roche and ABI (Thermo Fisher).
As the global spread of coronavirus infection increases, it is likely that a variety of diagnostic tools will be needed for direct clinical care via specialist laboratories, central hospital labs and in the community. It is likely that millions of people will need to be tested, and high throughput PCR molecular testing will play a central role. Genedrive aims to deliver clinically verified, consistent and reproducible assays that are easy to use and can be manufactured and delivered globally in high volume. Working with Cytiva will help us achieve this goal.