Biotechnology company BioVaxys Technology Corp (CSE:BIOV) (FRA:5LB) stated on Friday that it has filed an application for a pre-IND (Investigational New Drug) meeting with the US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research.

The company added that the pre-IND meeting is a critical step in the US regulatory process as it provides an opportunity for study sponsoring companies to obtain clarity from the US FDA on clinical trial design, clinical material manufacturing and quality control.

In addition, the company has submitted a briefing package with the US FDA for its T-cell immune response diagnostic for SARS-CoV-2, the Covid-T. It now awaits a written response on the pre-IND briefing package.

According to the company, Covid-T uses Delayed-type hypersensitivity (DTH), which is known as a measure of T-cell immunity and has been used for many years for other infectious diseases. The test is carried out by using a small amount of synthetic test material, B. SARS-Cov-2 spike protein, placed intradermally and the site examined 24 hours later for slight induration. Skin test antigens are considered biological products and are regulated by the Office of Vaccine Research and Review (OVRR) of CBER.