Applied DNA Sciences Inc (APDN)

[HANUMAN]

I received this clarification email today:

Hello -

In response to your question below, on the assumption that we secure approval for our monkeypox virus test as an LDT from the New York State Department of Health (NYSDOH), our sales strategy is for our clinical lab subsidiary to serve as a reference lab to hospital systems and larger clinical labs in New York State, as well as clinical labs located in other States that allow sample processing by clinical labs permitted under the New York State Department of Health Clinical Laboratory Evaluation Program (CLEP), currently approximately 46 states nationwide. Any samples collected from NYS or another state under CLEP-permittance can only be processed in our clinical lab in N.Y.

We have experience in this model this year as we served as a reference lab for COVID-19 testing, for which we utilize an internally-developed diagnostic test conditionally approved as an LDT by NYSDOH. If approved, our monkeypox test would follow the same path to market.

Given this, we have no current plans to seek FDA approval for this diagnostic. To be precise, we are not a diagnostics manufacturer. Rather, we are a testing services provider that has developed a PCR-based test that requires a workflow that is unique to our clinical lab and leverages the established workflow for our COVID-19 testing service. This then makes the LDT regulatory path the optimal one for us.

We offered a deeper discussion into this diagnostic's path to market on our quarterly investor call last week, which you can access here: https://investors.adnas.com/news-events/company-events/