RNS:2 Jun 2020 08:40
02/06/2020 7:00am
UK Regulatory (RNS & others)
Novacyt (LSE:NCYT)
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Tuesday 2 June 2020
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TIDMNCYT
RNS Number : 6039O
Novacyt S.A.
02 June 2020
Novacyt S.A.
("Novacyt" , the "Company" or the "Group" )
Coronavirus update
Sales and regulatory update
Paris, France and Camberley, UK - 2 June 2020 - Novacyt ( EURONEXT GROWTH: ALNOV; AIM: NCYT ), an international specialist in clinical diagnostics, provides an update on its polymerase chain reaction (PCR) test for COVID-19, developed by Primerdesign, the Company's molecular diagnostics division.
Sales
As of 1 June 2020, sales of the Primerdesign COVID-19 test are EUR45 million (GBP40 million). In addition, Primerdesign has received orders for, or been contracted to deliver, a further EUR90 million (GBP80 million) of its COVID-19 test. Therefore, currently the total sales and confirmed orders are EUR135 million (GBP120 million).
During the second half of the year, additional COVID-19 related sales are expected from the Company's new products, Exsig(TM) Direct and Exsig(TM) Mag, and from the Company's mobile testing solution (see further detail below).
Novacyt is now selling its COVID-19 test into more than 130 countries, with the top two countries being the UK and Germany. Novacyt is also pleased with the progress it is making in the US market and expects to update the market in due course.
Zimbabwe tender win
Following completion of a formal evaluation of the Primerdesign COVID-19 test by the Medicines Control Authority of Zimbabwe and a successful tender process, Zimbabwe's Ministry of Health and Child Care has awarded Primerdesign with a contract for the supply of 1.5 million tests. Outside the UK, this is the largest contract secured by Novacyt to date. The initial purchase order for the first 500,000 tests has been received and will be shipped immediately. The remaining one million tests will be shipped over the coming weeks.
Regulatory - France
Following several months of discussions with the Haute Autorité de Santé (HAS), which advises the French government on medical reimbursement, the Company reports that HAS has not approved Primerdesign's COVID-19 test for reimbursement in France. This decision by HAS is despite clinical approval from the Institut Pasteur, an internationally renowned centre for biomedical research with a goal of improving public health in France, which the Company received on 6 April 2020. HAS stated it will not authorise reimbursement because the COVID-19 test has been developed with one single gene target. Novacyt can still sell the test in France for private patient testing.
Regulatory - other territories
During the last few weeks, Novacyt has secured registrations and regulatory approvals in the following new markets for its COVID-19 test: Panama, Ecuador, Columbia, Peru, Paraguay and the UAE.
New products
As announced on 14 May 2020, the Compan
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