Therapy Areas: Oncology
Applied DNA Forms Clinical Testing Subsidiary to Maximise Utility of FDA EUA-Approved Linea COVID-19 Assay Kit
9 July 2020 - - US-based molecular technologies provider Applied DNA Sciences Inc. (NASDAQ: APDN) has formed a wholly-owned subsidiary, Applied DNA Clinical Labs, LLC, dedicated to the commercial development of its tests in Virology, for the detection of COVID-19, and in Oncology, for the detection and enumeration of invasive Circulating Tumor Cells (iCTCs), the company said.

With the formation of ADCL, the company is executing on a strategy to expand its market reach through value-added services complementary to a growing portfolio of diagnostic assays attractive to a broader number of qualified labs.

ADCL allows Applied DNA to be a direct beneficiary of its own diagnostics development beyond the sales of kits to qualified laboratories, and provides the clinical sampling framework necessary to obtain the data required by State and Federal regulatory authorities to develop and improve diagnostics and vaccines in the face of a pandemic with rapidly shifting genetics and infectious behavior.

In mid-May, Applied DNA received Emergency Use Authorization for a high sensitivity, high-throughput complex molecular test for SARS-CoV-2, the coronavirus that causes COVID-19. The Linea COVID-19 SARS-CoV-2 Assay Kit is a real-time polymerase chain reaction (RT-PCR) test for the qualitative detection of SARS-CoV-2 RNA in respiratory specimens. It provides a high-throughput solution to help laboratories address the urgent need for patient testing during the Coronavirus pandemic.

The company also announced that the amendment of its EUA was approved by FDA to include extraction and concentration of the viral RNA by a magnetic method of nucleic acid extraction that lends itself easily to high throughput scaling with robotics and diversifies the two extraction methods already covered by the existing EUA.

A series of EUA amendments are planned to introduce automation for increased throughput and accuracy, gain approval for additional RNA extraction methods and PCR devices to expand the footprint where our EUA assay can be used, develop point-of-care testing and simplify sample acquisition from patients.

The company believes that as the demand for testing grows and diversifies, the existing approval of the company's Linea COVID-19 Assay Kit for use with anterior nasal swabs will facilitate uptake by certified testing labs.

As opposed to nasopharyngeal swabs, anterior nasal swabs only enter less than 1 inch into the nose, allowing for sampling with minimal irritation or discomfort.

Additionally, anterior nasal swabs may be self-collected at a healthcare location or collected by a healthcare worker.

ADCL, the company's new subsidiary was formed to enable clinical testing of patient specimens using methods developed by the company's research teams.

Access to clinical specimens will also facilitate more rapid development of improvements and new assays. All of these continuous improvements are designed to help drive sales to other approved testing labs.

ADCL was also formed to facilitate the use and development of the company's Liquid Biopsy platform for detecting iCTCs in the blood of cancer patients, far simpler and safer than surgical or needle biopsies, and is already in use under contract in a Phase III clinical trial of a promising drug for the treatment of Stage IV pancreatic cancer.

The trial involves 3,000 samples and the quantification of metastatic cancer cells in the blood.

The company has obtained its Permanent Facility Identifier for ADCL, has hired a New York State Licensed Clinical Laboratory director for Oncology and Virology and Certified Laboratory Scientists, and has applied for a license from the New York State Department of Health.

There can be no assurance that this license will be obtained, or that FDA will maintain the Emergency Declaration that enabled the EUA program for COVID-19 diagnostics.

There can be no assurance that the company will obtain approved 510K status (or other necessary regulatory approval) for its COVID-19 In Vitro Diagnostics in the event that the Emergency Declaration is lifted.

In addition, the company's iCTC assay is currently limited to RUO (Research Use Only), and there can be no assurance that the company will obtain the necessary regularly approval for its iCTC assay to expand its use outside of RUO limitations.

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.
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