Diagnostics firm provides update on PCR COVID-19 test

Clinical diganostics company Novacyt has provided an update on its polymerase chain reaction (PCR) test for COVID-19, developed by Primerdesign, its molecular diagnostics division based in the UK.

As of 28 April 2020, Primerdesign has sold, received orders for or has been contracted to deliver over £90 million of its COVID-19 test. This figure includes the contracted minimum amount of test orders from the recently signed supply agreement with the UK’s Department of Health and Social Care and initial orders received to date from the collaboration with AstraZeneca, GSK and the University of Cambridge. 

Novacyt is supplying its COVID-19 test to more than 100 countries and approvals for the test have recently been received from Malaysia and Ecuador. The company continues to increase its sales level into the US market and is evaluating potential options to further expand its presence in this important market.

On 15 April 2020, Novacyt announced plans to increase manufacturing capacity to approximately eight million tests per month, and expects to achieve this target in June. It has also signed manufacturing partnership agreements with two further contract manufacturers based in the UK. This provides Novacyt with a total of six sub-contract manufacturers in addition to its own manufacturing sites in Southampton and Camberley.   

As announced on 15 April 2020, Novacyt has been developing a new extraction technology. This technology avoids the use of magnetic beads commonly used in the extraction process. The development of a new “direct-to-PCR” extraction method, Exsig Free, used prior to running the company’s COVID-19 test, will therefore remove the need for scarce reagents used with magnetic beads and significantly reduces the number of extraction steps, allowing faster cycle times, higher throughputs and cost savings. The Directors believe this innovation should facilitate an increase in testing capacity for COVID-19, removing a current bottleneck in sample processing for laboratories. The company says it is on track to launch this new extraction technology in May.

Graham Mullis, chief executive officer of Novacyt, said: “The visibility of the sales order book is transformational for the business and it is becoming increasingly clear that this exceptional demand for our COVID-19 test could continue for some months. As a result, we continue to ensure we have significant capacity and flexibility in the manufacturing of our COVID-19 test.

“I am proud that innovation remains at the heart of the business and the forthcoming launch of our Exsig Free extraction kit will address a significant market need to increase testing availability and throughput. This is a challenging time for Novacyt but the transformation of our financial performance and our position as a market leader in clinical diagnostics means we are confident in the long-term prospects of the business.”