Applied DNA’s diagnostic kit for SARS-CoV-2

Applied DNA Sciences, a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing for product authenticity, traceability solutions, nucleic acid-based biotherapeutic development, and diagnostics, announced the completion of design of a diagnostic kit for SARS-CoV-2 (the virus that causes the disease COVID-19) being developed for production via the Company’s proprietary PCR-based DNA (LinearDNA™) manufacturing process.

The company’s announcement follows its statement on March 2, 2020, updating their collaborative progress with Takis Biotech, in Rome, Italy, on a series of LinearDNA™ vaccine candidates against the Spike protein of SARS-CoV-2. Yesterday’s announcement highlighted that the preclinical trials for the jointly developed vaccines have been authorized by the Italian Ministry of Health, and are the first trials in Italy to have reached this stage.

The recently designed novel diagnostic kit focuses on the gene that encodes the surface spike (S) protein, an essential glycoprotein for viral entry into human host cells. Said Dr. James Hayward, president and CEO of Applied DNA: “We aligned 74 variants of the S-gene sequence currently available in the NCBI (National Center for Biotechnology Information) database. This gene is highly conserved, being close to 100 per cent (99.97 per cent) identical across variants; meaning that detection via our diagnostic kit under development should be consistent even against the capacity for this virus to mutate. We believe that we are the first company to engage both in detection and prevention of COVID-19.”

“After in-silico analysis, the assay appears highly accurate and specific for SARS-CoV-2”, said Yuha Sun, Director of Applied Genomics at Applied DNA, and one of the developers of the assay. “Applied DNA plans to conduct in-vitro verification of the in-silico analysis in the coming weeks.”

“Because the Spike protein is very abundant on the virus surface, many copies of the messenger RNA are present per host cell, increasing, we believe, the probable sensitivity of the diagnostic,” said Dr. Mohan Chellani, Director of Diagnostic Regulatory Affairs at Applied DNA.

The company will undertake the PCR-based manufacture of the positive controls for its proposed kit under its LinearDNA platform and believes that its capacity for such manufacture is unmatched anywhere in the world. “We are approaching partners for the validation of our pending diagnostic with samples from confirmed COVID-19 patients,” continued Dr. Hayward. “We believe our capacity for PCR-based manufacture of linear DNA could be of utility to other diagnostic and vaccine manufacturers.”

Applied DNA makes clear that no commercial partner has been identified to take the developmental diagnostic to market, nor is there any indication that the Company’s diagnostics would be approved by regulators. The assay will use the Applied Biosystems 7500 Fast Dx Real Time PCR instrument, widely deployed in diagnostic labs and hospitals the world over. Once fully validated and ready for shipment, the Company plans to sell the diagnostic kit as “For Research Use only” while awaiting the potential Emergency Use Authorization by FDA, which would empower sales to diagnostic labs.