Novacyt S.A. ("Novacyt", the "Company" or the “Group”)

R&D Update - Seite 3

Development of a two gene test

Whilst the Company’s COVID-19 test continues to demonstrate a market leading performance in terms of specificity and sensitivity, there are a number of countries legislating that a two-gene testing approach is employed. This approach is driven by concerns regarding mutation of the virus and the inability for some other PCR tests to detect positive cases.

Whilst Novacyt is able to demonstrate the superiority of its specific single gene approach, with the test having received emergency use authorisation from most major health bodies, including the US FDA and WHO, the insistence on deployment of two gene tests has impaired the Company’s ability to penetrate certain markets. The Company is therefore finalising the development of its own two gene target test and expects to launch this two gene test no later than September 2020.

Serology (antibody) testing

It has been widely documented that healthcare providers require an effective method to identify individuals who have previously been exposed to COVID-19 and who may therefore have immunity to further infection. Serological methods typically try to distinguish between IgM and IgG antibodies.

The human immune response to infection results in the body producing different types of antibodies at different stages of the infection, with IgM being produced before IgG. However, the initial antibody response is not produced immediately and may not be detectable until up to 14 days after infection. Therefore, detection of viral RNA by PCR testing is the most sensitive method of choice in early diagnosis of infection, often in patients who are showing few or no clinical symptoms. The IgM antibody response is also short lived. However, the body generates a longer lasting response with the production of IgG antibodies. It is these IgG antibodies that are indicative of past infection and which can typically impart some form of immunity against future infection.

Following extensive investigation of a number of serological methods, Novacyt is working with a partner who has developed a test for the detection of the IgG antibody to COVID-19. To date, the product has demonstrated significant levels of sensitivity and specificity for detection of IgG in patients 14 days after testing positive for COVID-19 by a PCR test. Novacyt is now in the process of conducting its own performance evaluation to validate the serology test and will look to launch a CE Mark product during the fourth quarter of 2020.