Novacyt, a specialist in clinical diagnostics, is to launch two PathFlow COVID-19 antigen lateral flow tests (LFTs) to strengthen the its COVID-19 portfolio and to pursue new market opportunities, especially in point-of-care (POC) settings. 

The company will initially target private market opportunities for these LFTs via its existing distribution network.

Novacyt’s two new PathFlow COVID-19 antigen tests are small, instrument-free and contain all the components required for safe sample collection, preparation, testing, interpretation of results, and disposal for use by healthcare professionals or patients in home settings. The use of point-of-care testing is a first line rapid screening option and, therefore, Novacyt’s PathFlow antigen LFTs complement the company’s existing polymerase chain reaction (PCR) portfolio for SARS-CoV-2 diagnosis.

• PathFlow COVID-19 Rapid Antigen Pro is a CE marked LFT for professional use detecting SARS-CoV-2 antigens using either anterior nasal samples or nasopharyngeal samples to provide results in approximately 15 minutes. When using nasal swab specimens, the test demonstrated a sensitivity of 93.5% and specificity of 99.3% and when using nasopharyngeal swab specimens, it demonstrated sensitivity of 93.4% and specificity of 99.4%. Both sampling methods were tested against 316 samples. This product is available immediately.
• PathFlow COVID-19 Rapid Antigen is a self-test LFT to detect SARS-CoV-2 antigens using oral fluid samples and provides results in approximately 15 minutes. This test demonstrated a sensitivity of 90.1% and specificity of 99.3% from 303 clinical samples. The test offers mass screening for home, travel, events, and workplace markets. Novacyt expects to make this LFT available as a CE marked product shortly.

PathFlow COVID-19 Rapid Antigen Pro and PathFlow COVID-19 Rapid Antigen have been developed with a partner through an OEM agreement in conjunction with Novacyt’s Microgen Bioproducts division. 

Graham Mullis, chief executive officer of Novacyt, said: “Throughout the pandemic we have continued to launch new products to ensure our COVID-19 portfolio remains at the forefront of our industry. These two antigen LFTs will support our customers as the market continues to evolve towards private testing and we believe they will become a useful entry point to our existing range of PCR COVID-19 tests. With the potential for a flu season starting in the northern hemisphere in a few months it will be important to know whether a person has flu or SARS-CoV-2 and having access to quick results are critical to patient treatment and containing the spread of the COVID-19 virus. These LFTs add to our existing PathFlow range, which is a portfolio for the rapid diagnosis of a number of infectious diseases, and we will continue to evaluate other COVID-19 POC tests to meet the changing demands of the market.”