– Announces Completion of Initial New York State Department of Health Inspection of Clinical Lab Subsidiary –
STONY BROOK, N.Y.–(BUSINESS WIRE)–$APDN #COVID19–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 LineaTM 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.”
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 LineaTM 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.
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’.
Applied DNA is a member of the Russell Microcap® Index.
About the LineaTM COVID-19 Assay Kit
The LineaTM COVID-19 Assay Kit is authorized by FDA EUA for the qualitative detection of nucleic acid from SARS-CoV-2 in respiratory specimens, including anterior nasal swabs, self-collected at a healthcare location or collected by a healthcare worker, and nasopharyngeal and oropharyngeal swabs, mid-turbinate nasal swabs, nasopharyngeal washes/aspirates or nasal aspirates, and bronchoalveolar lavage (BAL) specimens collected by a healthcare worker from individuals who are suspected of COVID-19 by their healthcare provider.
The scope of the LineaTM COVID-19 Assay Kit EUA, as amended, is expressly limited to use consistent with the Instructions for Use by authorized laboratories, certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform high complexity tests. The EUA will be effective until the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 is terminated or until the EUA’s prior termination or revocation. The diagnostic kit has not been FDA cleared or approved, and the EUA’s limited authorization is only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens.
The Company is offering surveillance testing in compliance with current CDC, FDA, and CMS guidances. The use of pooled saliva sampling for surveillance testing, which has been internally validated by the Company in compliance with current surveillance testing guidances, is not included in the Company’s EUA authorization for the LineaTM COVID-19 Assay Kit.
The statements made by Applied DNA in this press release may be “forward-looking” in nature within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. Forward-looking statements describe Applied DNA’s future plans, projections, strategies and expectations, and are based on assumptions and involve a number of risks and uncertainties, many of which are beyond the control of Applied DNA. Actual results could differ materially from those projected due to, its history of net losses, limited financial resources, limited market acceptance, the uncertainties inherent in research and development, future clinical data and analysis, including whether any of Applied DNA’s or its partner’s diagnostic candidates will advance further in the preclinical research or clinical trial process, including receiving clearance from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies to conduct clinical trials and whether and when, if at all, they will receive final approval from the U.S. FDA or equivalent foreign regulatory agencies, the unknown outcome of any applications or requests to U.S. FDA, equivalent foreign regulatory agencies and/or the New York State Department of Health, the unknown limited duration of any Emergency Use Authorization (EUA) approval from U.S. FDA, changes in guidances promulgated by the CDC, FDA and/or CMS, disruptions in the supply of raw materials and supplies, and various other factors detailed from time to time in Applied DNA’s SEC reports and filings, including our Annual Report on Form 10-K filed on December 12, 2019 and our subsequent quarterly reports on Form 10-Q filed on February 6, 2020, May 14, 2020 and August 6, 2020, and other reports we file with the SEC, which are available at www.sec.gov. Applied DNA undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, unless otherwise required by law.
Investor contact: Sanjay M. Hurry, Applied DNA Sciences, 917-733-5573, [email protected]
Program contact: Mike Munzer, Applied DNA Sciences, 631-240-8800, [email protected]