PARIS – Novacyt SA has obtained CE marking approval for its polymerase chain reaction (PCR) respiratory virus test panel, Winterplex. “This new test panel includes two gene targets specific to COVID-19, as well as other gene targets. It can differentiate between COVID-19 and other common respiratory diseases, including influenza A&B and respiratory syncytial virus,” Graham Mullis, group CEO of Novacyt SA, told BioWorld.
Health care providers are currently facing major challenges this fall. It is difficult for them to differentiate COVID-19 from other respiratory diseases, particularly during a seasonal flu outbreak, due to patients presenting with similar symptoms. “This is driving the requirement for the development of respiratory test panels that are able to diagnose and distinguish between different types of flu and COVID-19,” said Mullis.
Sensitivity of the COVID-19 diagnosis pioneer.
Formed in 2006, The Anglo-French Novacyt Group, based in Surrey, U.K., and Vélizy-Villavoublay, France, is focused on molecular and protein testing in clinical diagnostics. Its business divisions include Primerdesign, a spin-off company from the University of Southampton Medical School, Microgen Bioproducts and Lab21 Healthcare.
“Novacyt has established itself as a pioneer in COVID-19 diagnostics through the rapid development and success of its COVID-19 PCR test,” said Mullis. Primerdesign, its molecular diagnostics division based in Southampton in the United Kingdom, launched the world's first molecular test for COVID-19 in January 2020. This earned an initial surge in its share price of 120%. This test was the first to obtain CE marking approval. It was subsequently approved for emergency use by the U.S. FDA and the World Health Organization (WHO).
Novacyt has used its specialization in rapid development of molecular solutions to expand its portfolio of COVID-19 solutions. These include direct-to-PCR products (exsig COVID-19 Direct, which significantly reduces the time-to-result by reducing the burdensome pre-analytical extraction phase of testing) and “our imminent 2-gene assay launch to support testing in markets where a 2-gene testing approach is mandatory, as well as patient-proximity testing solutions,” according to Mullis.
Winterplex – 3 months from initial product design to launch
Finally, its latest product launch is Winterplex, aimed at supporting testing during the winter season. “Our R&D team has broken all speed records,” said Mullis. The time frame from initial product design to launch, was just three months. Their team of scientists was able to deliver the finished product within four weeks of submitting product specifications. The Winterplex test is based on nucleic acid amplification technology.
The Winterplex test panel includes two gene targets specific to COVID-19, as well as gene targets for influenza A&B and respiratory syncytial virus (RSV). Clinical trial data demonstrated 100% specificity and between 96% and 100% sensitivity across the panel: 98% overall agreement for influenza A, 100% for influenza B, 100% for RSV and 100% for COVID-19.
The test panel is designed to be used on any open PCR platform, including the company's rapid, portable q32 instrument. This latest, next-generation instrument delivers test results in 60 minutes using Genesig kits. “This makes it one of the fastest qPCR instruments on the market due to its rapid heating and cooling capacity and unique lid design,” said Mullis.
More than $24M free cash and debt-free
Novacyt is using its existing manufacturing capacity to produce the test panel, and believes it can meet expected total global demand for the product. Particularly since, over the past six months, the Anglo-French group of 149 employees spread over three sites in Europe has grown its production capacity. “Today, we have eight production sites capable of producing COVID-19 tests, at a rate of over ten million tests each month,” said Mullis.
The Anglo-French group, with a market cap of $300 million, posted unaudited revenues for the first half of 2020 increased by over 900% to $85 million, compared to revenues of €8.5 million for the first half of 2019, with 91% of revenue accounted for in the second quarter. The group is estimating EBITDA for the first half of the year at over $53 million. “This follows the successful launch of one of the world’s first molecular tests for COVID-19, which we rapidly developed and launched in January of 2020,” said Mullis.
The new test panel from Novacyt is expected to drive significant incremental revenue for the group. Novacyt was already enjoying handsome free cash flow. The latter amounts to more than $24 million, compared to just $2 million 10 months ago. With this high level of cash, the Anglo-French firm is debt-free for the first time in its history. “This will allow us to invest heavily to meet the demand for COVID-19 tests, which will continue into the second half of this year,” said Mullis.