Novacyt S.A.: Launch of Three Innovative Products to Support COVID-19 Testing

PARIS & CAMBERLEY, England--(BUSINESS WIRE)--Regulatory News:

Novacyt (EURONEXT GROWTH: ALNOV; AIM: NCYT) ("Novacyt", the "Company" or the “Group”), an international specialist in clinical diagnostics, announces the launch of three new products to support laboratories testing for COVID-19. These are Exsig™ Direct and Exsig™ Mag, two RNA extraction kits for use prior to running a polymerase chain reaction (PCR) test for COVID-19, and COVID-HT, a high-throughput test for COVID-19.

Exsig™ Direct and Exsig™ Mag
In addition to supporting laboratories through the supply of its COVID-19 test, Novacyt has developed two RNA extraction kits, Exsig™ Direct and Exsig™ Mag, to help address the current reported global shortfall in extraction reagents required to perform PCR testing. The extraction of RNA is a key pre-analytical step in COVID-19 testing and must be performed before running the PCR test on the RNA extract. The two kits can be used with all open instrument platforms for running a PCR test and offer customers different benefits; Exsig™ Direct provides significant workflow improvements whilst Exsig™ Mag offers enhanced sensitivity of the Company’s COVID-19 test.

Exsig™ Direct is an innovative direct-to-PCR extraction kit which removes the need for complex, automated magnetic bead extraction systems. It is designed to be used with the Company’s COVID-19 test and is expected to significantly improve laboratory workflow, reduce cycle times, increase throughput by up to 50% and reduce costs. It uses a combination of optimised buffers to extract COVID-19 RNA from clinical samples. These buffers have been specifically designed and clinically tested to ensure the high level of testing performance of the Company’s COVID-19 test is maintained. Novacyt also plans to optimise the use of this new extraction method in future PCR tests to be developed and launched by the Company.

Exsig™ Mag is a new extraction kit designed to run on multiple automated magnetic bead extraction systems commonly used by clinical laboratories around the world. Exsig™ Mag has been developed to enhance extraction of COVID-19 RNA from clinical samples and, when used in combination with the Company’s COVID-19 test, offers ultra-sensitive detection of COVID-19. Exsig™ Mag can also be used in combination with other COVID-19 PCR tests.

COVID-HT test
COVID-HT is a new test for COVID-19 optimised for use in laboratories performing high volumes of tests. The CE Mark test has been designed and validated to perform at the same high levels of specificity and sensitivity as the Company’s existing COVID-19 test.

COVID-HT uses the Company’s proprietary master mix which, unlike the standard COVID-19 kit, requires no premixing, and the test components are packaged to facilitate a more streamlined workflow in a highly automated laboratory setting. As a result, COVID-HT is expected to improve operational efficiency and save time and labour associated with handling and preparing the test for use.

Exsig™ Direct, Exsig™ Mag and COVID-HT are immediately available and manufacturing capacity has been developed to meet potential demand.

Graham Mullis, Group CEO of Novacyt, commented:
“As we continue to supply our COVID-19 test to laboratories around the world, we are delighted to provide further support through the launch of these new products. We believe there will be significant demand for our new extraction kits, particularly at this time when automated RNA extraction reagents are in short supply. In addition, our high-throughput test, for use in large volume clinical laboratories, should enable more efficient workflow which is critical to achieve optimal testing volumes. We look forward to continuing to work with our customers to support their testing requirements through new and innovative solutions.”

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