PARIS & CAMBERLEY, England--(BUSINESS WIRE)--Regulatory News:
Novacyt (EURONEXT GROWTH: ALNOV; AIM: NCYT), an international specialist in clinical diagnostics, announces that, further to the announcement on 27 July 2020, the Company has launched a CE-Mark approved polymerase chain reaction (PCR) two gene target test for COVID-19.
The test, which provides an additional option to the Company’s successful single gene test, addresses the need of a number of countries which require a two gene target testing approach for COVID-19. This includes France, Belgium, Croatia, Poland and the UAE. The Haute Autorité de Santé, which advises the French government on medical reimbursement, has confirmed to the Company that the two gene COVID-19 test will qualify for reimbursement for use by French testing laboratories.
The two gene test has been developed to the same high standards of precision and performance as Novacyt’s single gene target test for COVID-19. The performance of the new test has been confirmed in validation studies undertaken by the Company.
The success of Novacyt’s single gene target test for COVID-19 has been built around robust design principles and the selection of a gene target that has so far demonstrated exceedingly low levels of genetic mutation and variation. To date, the gene target has been analysed against 60,256 individual COVID-19 viral sequences and demonstrated 100% detection. The two gene target test for COVID-19 will also be added to this weekly surveillance monitoring programme to demonstrate continued efficacy of the test to diagnose SARS-CoV-2.
Graham Mullis, Group CEO of Novacyt, commented:
“Novacyt continues to demonstrate its ability to rapidly develop new products to address needs within the diagnostics market to support laboratories and clinicians in the ongoing fight against the spread of COVID-19. We remain committed to building on Novacyt’s innovative position on a global scale as the demand for COVID-19 testing continues.”
This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014.
About Novacyt Group
The Novacyt Group is an international diagnostics business generating an increasing portfolio of in vitro and molecular diagnostic tests. Its core strengths lie in diagnostics product development, commercialisation, contract design and manufacturing. The Company's lead business units comprise of Primerdesign and Lab21 Products, supplying an extensive range of high quality assays and reagents worldwide. The Group directly serves microbiology, haematology and serology markets as do its global partners, which include major corporates.
For more information please refer to the website: www.novacyt.com