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Pharma & Biotech

Novacyt slips as reimbursement for coronavirus test rejected by French regulators

The diagnostics group said it will still be able to sell the test in France for private patient testing

Novacyt SA (LON:NCYT) shares slipped on Tuesday after the diagnostics firm said its polymerase chain reaction (PCR) test for coronavirus will not be reimbursed by regulators in France.

In an update, the AIM-listed group said the Haute Autorité de Santé (HAS), which advises the French government on medical reimbursement, had not approved the test for reimbursement in the country on the basis that the test has been developed with one single gene target. However, the company will be able to sell the test in France for private patient testing.

"Despite the decision from HAS not to reimburse our [coronavirus] test, we will continue to offer the test for private patient testing and evaluate new ways of supporting the French market. Our manufacturing scale-up is progressing to plan and we look forward to supporting current and additional countries with their testing requirements", said Novacyt chief executive Graham Mullis.

Away from the setback in France, the company reported that as of June 1 sales of the PCR test were £40mln and that its molecular diagnostics division, Primerdesign, has received orders to deliver a further £80mln-worth of the test, taking total sales and confirmed orders to £120mln.

The firm also said additional coronavirus-related sales are expected in the second half of the year from its new products, Exsig Direct and Exsig Mag, as well as from its mobile testing solution.

The Exsign products are on track to launch in June while the mobile testing system will launch in July.

Meanwhile, Novacyt said Primerdesign has been awarded a contract from Zimbabwe's Ministry of Health and Child Care to supply 1.5mln coronavirus tests, the largest order secured to date outside the UK.

The firm said the initial purchase order for 500,000 tests has been received and will be shipped immediately, with the remaining tests to be shipped over the coming weeks.

Novacyt said it is now selling the coronavirus test in over 130 countries, adding that over the last few weeks it has secured registrations and regulatory approvals for the test in Panama, Ecuador, Columbia, Peru, Paraguay and the UAE.

"We are encouraged by the increasing number of new markets validating our [coronavirus] test for clinical use, which can be seen in the significant increase in sales and order commitments received to date. The competitive tender process and subsequent award in Zimbabwe to support the country's national [coronavirus] testing effort is a key example of our increasing global reach. As new regions are impacted by the pandemic, we expect the demand for our [coronavirus] test to continue to grow”, Mullis said.

Shares in Novacyt were 3.7% lower at 322.8p in early trading.

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