15 January 2021 - - US-based DNA manufacturing company Applied DNA Sciences, Inc's (NASDAQ: APDN) safeCircle pooled surveillance testing service has seen a 158% increase in the daily average number of tests performed to date in January 2021 compared to December 2020, the company said.

The increase is chiefly the result of the scale-up of certain testing contracts and from the acquisition of new clients.

Launched in 4Q20 (ended September 30, 2020), safeCircle now counts 33 primary/secondary/higher education institutions, private client, local government, and businesses as clients.

Concurrently, the company said that it is increasing production of its Linea COVID-19 Assay Kit and sample collection kits to meet expected demand from existing customers, from its safeCircle service that is powered by the Assay Kit, and due to heightened interest in the Assay Kit following a recent US Food and Drug Administration's Food and Drug Administration alert that identified the assay as an EUA-approved molecular diagnostic test that can potentially identify certain SARS-CoV-2 mutations.

The company also said that Applied DNA Clinical Laboratories, LLC, its wholly-owned subsidiary, is on track to submit a request for CLEP-CLIA re-inspection during the current quarter ending March 31, 2021.

If granted, CLEP-CLIA certification would enable ADCL to serve as a diagnostic laboratory that would allow for it to conduct diagnostic COVID-19 testing.


In recent weeks safeCircle has added new clients. They include The US division of a Germany-based international jewelry company for the testing of its New York-based staff; a private higher education institution based on Long Island, N.Y., for the testing of its residential and student-athlete populations; and a previously announced award with a local county government.

The company is also increasing the production of sample collection kits utilized in surveillance testing by a factor of four to meet the testing scale-up of the Assay Kit's largest customer and for use by new safeCircle clients.

Applied DNA's recently announced partnership with CLEARED4, a provider of return-to-work health safety solutions, has begun to bear fruit.

In addition to being utilized as a mobile-friendly, value-added option for the management of aggregate results testing and reporting to a key safeCircle client, Applied DNA is now providing CLEARED4 services to a second safeCircle client, the aforementioned jewelry company.

Applied DNA expects to onboard a third new client this week, the aforementioned private higher education institution.

The company believes that the combination of its safeCircle offering with the CLEARED4 platform is a compelling service in a marketplace that is in search of an accurate, easy-to-employ, faster-turnaround testing service that incents participation.

The company's largest customer for its Assay Kit expects to increase its use of the Assay and sample collection kits for its in-house surveillance testing program beginning in early February 2021 to coincide with its campus reopening for the Spring semester.

The customer's in-house program oversees the weekly surveillance testing of thousands of faculty and staff for the presence of COVID-19.

Applied DNA receives recurring replenishment orders from the customer for both Assay and sample collection kits to meet its in-house surveillance testing needs.

In response to the FDA Alert, the company is relaunching its sales and marketing strategy to center on the Assay Kit's potential ability to signal for the presence of a SARS-CoV-2 variant due to S-gene target dropout.

The company is in the process of completing remediation of deficiencies in ADCL's clinical standard of practice and expects to submit a request for re-inspection during the current quarter ending March 31, 2021.

CLEP-CLIA certification will enable ADCL to capture diagnostic COVID-19 revenues currently being conducted by third party clinical labs.

CLEP-CLIA certification would also potentially allow ADCL to develop an additional revenue stream through the development and commercialization of a range of diagnostic tests, as laboratory-developed tests, that once approved by the applicable regulatory authority, could be offered by ADCL.

The Linea 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 specimens collected by a healthcare worker from individuals who are suspected of COVID-19 by their healthcare provider.

The scope of the Linea 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 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 saliva and pooled 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 Linea COVID-19 Assay Kit.

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.