On January 4, 2021 Applied DNA Sciences, Inc. (NASDAQ: APDN) ("Applied DNA" or the "Company"), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing, reported that it expects revenues for the first fiscal quarter of 2021 ended December 31, 2020, to be in the range of $1.3 million to $1.6 million compared to revenues of $314,000 in the fourth quarter of fiscal 2020 (Press release, Applied DNA Sciences, JAN 4, 2021, View Source [SID1234573398]). The strong sequential growth in quarterly revenues is driven principally by demand for safeCircle, the pooled COVID-19 surveillance testing program offered by the Company’s wholly-owned subsidiary, Applied DNA Clinical Laboratories, LLC (ADCL), and from sales of its LineaCOVID-19 Assay Kit under U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA).
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"Fiscal first-quarter revenues surged over fiscal fourth quarter, reflecting the first full quarter of revenue contribution from our safeCircle program. New client acquisitions drove a sequential improvement in ADCL revenues during each month of the quarter. We believe we are tapping into an unmet need for an accurate, painless, and fast COVID-19 risk mitigation option that can deliver ongoing, consistent, and highly accurate COVID-19 surveillance testing proactively. We expect continued uplift to revenues over the coming weeks as new clients ramp up their testing volumes, including Suffolk County (N.Y.) Government that signed on just two weeks ago with a six-month contract valued at up to $2.0 million, and as we onboard more new clients," said Dr. James A. Hayward, president and CEO, Applied DNA.
"Interest in our pooled surveillance testing modality is strong and growing. In the months ahead, our ADCL team is intensely focused on increasing testing throughput, developing new COVID-19 assays to detect mutations in SARS-CoV-2, offering expanded services via the Cleared4 return-to-work health safety platform, and client acquisition and retention through direct sales efforts and channel partners," concluded Dr. Hayward.
These preliminary unaudited results are based on management’s initial analysis of operations for the first fiscal quarter of 2021 ended December 31, 2020, and are subject to review and revision. The Company expects to issue full financial results for the first fiscal quarter of 2021 in mid-February.
About safeCircle
ADCL’s pooled surveillance testing program, known as safeCircle, utilizes frequent, high-sensitivity pooled testing to help prevent virus spread by quickly identifying infections within a community, school, or workplace. safeCircle provides 24-hour results using real-time PCR (RT-PCR) testing.
Click through to learn more about how safeCircle can help your community, school, and workplace: safeCircle
About the LineaCOVID-19 Assay Kit and Pooled Surveillance Testing
The LineaCOVID-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 LineaCOVID-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 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 LineaCOVID-19 Assay Kit.