Correction: Research and Development Update
Wed, 24th Feb 2021 18:30
RNS Number : 2611Q
24 February 2021
("Novacyt", the "Company" or the "Group")
Correction: Research and Development Update
This is a correction to the Research and Development Update announcement published at 7:00am on 24 February 2021 (RNS number 1141Q) which has been amended with the following underlined additions to make it consistent with the French announcement released on Euronext at 8:00am CET on 24 February 2021.
Under the subtitle 'Launch of CE Mark COVID-HT Direct'
· Novacyt announces the launch of its next generation high-throughput PCR test for COVID-19 (COVID-HT Direct), which has been CE Mark approved using independent validated data.
· The new COVID-HT Direct uses pharyngeal swabs collected in viral transport media (without guanidine) and saline
Under the subtitle 'Successful completion and publication of TVG validation of PROmate™'
· This TVG accreditation supports the use of the q16/q32 and PROmate™ system in a near patient setting, and its current deployment across the NHS and to international markets.
All other information remains unchanged. The full corrected announcement is included below.
Paris, France and Camberley, UK - 24 February 2021 - Novacyt (EURONEXT GROWTH: ALNOV; AIM: NCYT), an international specialist in clinical diagnostics, announces an update on the progress of its near-term research and development programmes, including the expansion of its product portfolio, clinical trial activity and the publication of independent validations of the Company's COVID-19 tests.
In parallel with the current focus of continuing to maximize the opportunity for COVID-19 testing, the Company is also continuing to build on its strategy for delivering a sustainable, long-term diagnostics business. Novacyt intends to present these plans during Q2 2021.
The expansion of the Company's COVID-19 portfolio continues to address the rapidly evolving diagnostics market:
· Expansion of the SNPsig® portfolio to detect new SARS-CoV-2 variants of concern, including a specific variant prevalent in the US
· Launch of CE Mark COVID-HT Direct, a next generation direct-to-PCR SARS-CoV-2 test for high-throughput laboratories
· Development of the COVID-19 antibody lateral flow test
· Development of the loop-mediated isothermal amplification COVID-19 test
· Development of an innovative assay panel for the detection of aspergillus, a respiratory fungal infection associated with co-infection risk in patients with COVID-19
· Development of a two-gene target PROmate™ test to address markets employing this testing approach
The Company continues to support clinical research teams undertaking clinical trials in the global COVID-19 testing market:
· Queen Mary University of London has successfully completed the clinical trial of rapid testing in care homes using the Company's rapid PCR system
· The variant diagnostic surveillance study has initiated in the UK, US, and Latin America
Novacyt's COVID-19 portfolio continues to be supported by independent validations and accreditations:
· The DHSC Technical Validation Group reported the successful completion of the in-service validation of PROmate™
· AstraZeneca reported the successful implementation of saliva testing of staff using Novacyt's genesig® COVID-19 assay
Expansion of the SNPsig® portfolio
With the rapid emergence of significant SARS-CoV-2 variants, the Company has expanded the polymerase chain reaction (PCR) genotyping portfolio, SNPsig®, announced on 2 February 2021, to incorporate the detection of two new variants of concern (VOC), first identified in Bristol (202102/02)1 and California (B.1.429/CAL.20C)2. These additions demonstrate the Company's ability to match the rapid evolution of the virus with real-time bio-informatics surveillance and accelerated product development. The variant diagnostics surveillance study, also announced on 2 February 2021, has initiated in sites in the UK, US and Latin America, enabling scientists and healthcare professionals in the field to determine the incidence of the principal VOC in their populations and to formulate strategies for containment and / or specific patient management.
Launch of CE Mark COVID-HT Direct
Novacyt announces the launch of its next generation high-throughput PCR test for COVID-19 (COVID-HT Direct), which has been CE Mark approved using independent validated data. This follows the launch of the Company's first high-throughput PCR test for COVID-19 (COVID-HT) in June 2020. The new test eliminates the need for automated extraction systems in a high-volume PCR laboratory, reducing processing time, cost and labour of testing by up to 30%. The new COVID-HT Direct uses pharyngeal swabs collected in viral transport media (without guanidine) and saline. COVID-HT Direct is already in use at one of the UK's Lighthouse laboratories and is being validated for use with private high-throughput PCR laboratory partners.
Development of an antibody lateral flow test for COVID-19
The Company continues to work on developing an IgG antibody lateral flow test (LFT) for use as a rapid antibody test for professional use. An LFT is an easy-to-use diagnostic device used to confirm the presence or absence of a pathogen or biomarker and takes approximately 10-20 minutes or less to provide a result.
The Company expects to launch its LFT in Q2 2021, slightly later than planned as it has taken the strategic decision to develop a next generation of LFT to detect the neutralizing antibodies generated by successful immunisation and, therefore, to assist in monitoring the effectiveness of future vaccines 3. The Company believes this exemplifies how it can extend the revenue horizon for COVID-19 as the demand for testing continues to evolve.
Development of a loop-mediated isothermal amplification COVID-19 test
Further to the announcement on 16 November 2020, the Company has completed early studies using its loop-mediated isothermal amplification (LAMP) technology with its q16 and q32 instrument platforms and open LAMP platforms and demonstrated encouraging initial results. Novacyt continues to evaluate the ongoing opportunity for LAMP testing and will launch its technology subject to demand.
Development of a new test panel to detect aspergillosis fungal infections
Aspergillosis is an infection caused by aspergillus fungus common in immune compromised patients4, and more recently has been associated with co-infection in patients with SARS-CoV-25 infections and COVID-19-associated pulmonary aspergillosis6. The infection is associated with long-term ventilation of patients. Outside of SARS-CoV-2 infections, aspergillosis also remains a potentially serious respiratory infection, affecting ~5 million patients worldwide7.
Novacyt's new multiplex PCR assay panel will detect all five major aspergillus sub-types and will run on the Company's q32 instruments, as well as open platforms. Novacyt expects to begin validation studies soon, with the potential to launch during H2 2021.
Once launched, the new assay panel will be the second product in the Company's COVID-19+ portfolio, following the launch of the Winterplex™ multiplex assay panel in August 2020. This launch is also in line with Novacyt's strategy to expand its portfolio of clinical use, respiratory diagnostic products.