Announces Completion of Initial New York State Department of Health Inspection of Clinical Lab Subsidiary

STONY BROOK, N.Y. October 12, 2020 – Applied DNA Sciences, Inc. (NASDAQ: APDN) (“Applied DNA” or the “Company”), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing that enables in vitro diagnostics, pre-clinical nucleic acid-based therapeutic drug candidates, supply chain security, anti-counterfeiting, and anti-theft technology, announced that Applied DNA Clinical Laboratories, LLC (“ADCL”), its wholly-owned subsidiary, has secured COVID-19 surveillance testing contracts under its testing-as-a-service (“TaaS”) offering that are estimated to generate more than $1.0 million in total annualized revenue beginning October 1, 2020. The Company’s surveillance testing revenue expectation is contingent on full-term participation by TaaS customers, including:

• Private schools based in Long-Island, N.Y., including Harbor Country Day School. Education customers comprise the bulk of the Company’s current testing volume;
• Several New York State-based small enterprises and private clients.

Unlike diagnostic testing, which looks for the occurrence of COVID-19 at the individual level, surveillance testing looks for infection within a defined population or community and can be used for making health management decisions at the population level.Surveillance testing does not require a prescription. In surveillance testing, pooled test results are returned to the sponsoring organization in the aggregate, not directly to the individual, and may be performed without CLIA certification.Concurrently, the Company is executing on a sales and marketing strategy to build a pipeline of Linea™ COVID-19 Diagnostic Assay Kit (“Assay Kit”) and TaaS opportunities through:

• Outreach to independent and hospital laboratories in COVID-19 hotspots nationally and regionally to offer an additional diagnostic kit supply line;
• Outreach to local laboratories to construct a reference laboratory relationship for overflow testing;
• Deployment of testing at Stony Brook University in accordance with a recently signed Master Services Agreement.

“Our capacity to perform COVID-19 surveillance testing is grounded in self-collection saliva kits and anterior nasal swab kits that are intuitive to use, a highly sensitive PCR-based Assay Kit that can detect as little as one copy of the SARS-CoV-2 genome per microliter in an individual saliva sample, and a high-throughput surveillance testing lab that can return testing results within 24 hours and often on the same day as sampling. When deployed as part of a consistent and ongoing surveillance testing regime, we believe our Assay Kit can help our clients to detect the virus before its median incubation time of 4 to 5 days from exposure to symptom-onset¹. Being able to identify infections early and in a cost-efficient and rapid manner is how surveillance testing gets workers back to work and students back to school,” said Dr. James A. Hayward, president and CEO.“We are beginning to see the first fruits of our Assay Kit and TaaS sales and marketing efforts translate into revenue,” concluded Dr. Hayward. “As we continue to expand our sales pipeline of Assay Kit and surveillance testing opportunities, we believe these efforts can serve as a potentially material driver of our growth supplemented by diagnostic customer testing upon receipt of CLEP-CLIA certification.”

For companies wishing to learn more about Applied DNA Clinical Labs’ surveillance testing program CLICK HERE

Update on CLEP-CLIA Certification
Separately, the Company announced that the State of New York Department of Health (DoH) completed the initial inspection of ADCL on October 7, 2020. Inspection reports are generally filed by the DoH within 4 to 6 weeks of the inspection date. A passing grade would confer onto ADCL DoH’s Clinical Laboratory Program (CLEP) certification under which ADCL can function as a certified clinical lab. CLEP-approved clinical laboratories located in New York State meet Clinical Laboratory Improvement Amendments of 1988 (CLIA) proficiency testing and accreditation requirements that would enable ADCL to receive patient samples collected nationally for testing. A failing grade would require ADCL to remediate deficiencies prior to any re-inspection request. The Company offers no timetable for receipt of CLEP-CLIA certifications at this time.

Use of Linea™ COVID-19 Assay Kit for Surveillance Testing
Pursuant to current guidances from the CDC, FDA, and CMS, Applied DNA’s Assay Kit can be marketed for surveillance and research use. Applied DNA has internally validated the Assay Kit for surveillance testing using pooled saliva samples for up to five samples. The Company notes that the use of pooled saliva samples is for surveillance testing only and has not been authorized under the Company’s EUA for the Assay Kit. CLEP certification would enable ADCL to perform the disambiguation of any positive pools identified in the Company’s surveillance testing program.

¹ “Interim Clinical Guidance for Management of Patients with Confirmed Coronavirus Disease (COVID-19)” Centers for Disease Control and Prevention, 10 Sept. 2020, https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-guidance-management-patients.html

About Applied DNA Sciences
Applied DNA is a provider of molecular technologies that enable supply chain security, anti-counterfeiting and anti-theft technology, product genotyping, and pre-clinical nucleic acid-based therapeutic drug candidates.

Visit adnas.com for more information. Follow us on Twitter and LinkedIn. Join our mailing list.

The Company’s common stock is listed on NASDAQ under ticker symbol ‘APDN’, and its publicly traded warrants are listed on OTC under ticker symbol ‘APPDW’.