Applied DNA Initiates Analytical Validation of PCR
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Posted On: 08/02/2022 7:13:13 PM
Applied DNA Initiates Analytical Validation of PCR-based Diagnostic Test Specific to Monkeypox Virus
Applied DNA Sciences, Inc. (NASDAQ: APDN) (the “Company”), a leader in polymerase chain reaction (“PCR”)-based technologies, announced that its wholly-owned clinical laboratory subsidiary, Applied DNA Clinical Labs, LLC (“ADCL”), has initiated analytical validation of a Company-developed, PCR-based monkeypox virus test that is specific for the genetic signature of the monkeypox virus. The test has been developed as a type of NYSDOH Laboratory Developed Test (“LDT”). If the test is validated by ADCL, a validation package will be submitted to New York State Department of Health (“NYSDOH”) for approval. If approved, the test will be used to power ADCL’s monkeypox testing services.
ADCL’s monkeypox test utilizes an A17L gene-target specific to monkeypox that enables the qualitative detection and differentiation of monkeypox virus from other non-variola orthopoxviruses using real-time PCR. If validated and approved, testing will be performed at ADCL’s CLEP/CLIA molecular diagnostics laboratory in Stony Brook, N.Y., utilizing its established and proven workflows to ensure accurate results and competitive turn-around-times.
“Based on our experience with the COVID-19 pandemic, we are keenly aware of the crucial role PCR-based diagnostic tools can play in responding and helping to control public health outbreaks. With a proven workflow and testing services born of COVID-19, upon test approval, ADCL stands ready to apply its testing capacity in service of New Yorkers’ health,” stated Dr. James A. Hayward, president and CEO of Applied DNA Sciences
https://investorshangout.com/recentnews/APDN#ixzz7aqrOlezh
Applied DNA Sciences, Inc. (NASDAQ: APDN) (the “Company”), a leader in polymerase chain reaction (“PCR”)-based technologies, announced that its wholly-owned clinical laboratory subsidiary, Applied DNA Clinical Labs, LLC (“ADCL”), has initiated analytical validation of a Company-developed, PCR-based monkeypox virus test that is specific for the genetic signature of the monkeypox virus. The test has been developed as a type of NYSDOH Laboratory Developed Test (“LDT”). If the test is validated by ADCL, a validation package will be submitted to New York State Department of Health (“NYSDOH”) for approval. If approved, the test will be used to power ADCL’s monkeypox testing services.
ADCL’s monkeypox test utilizes an A17L gene-target specific to monkeypox that enables the qualitative detection and differentiation of monkeypox virus from other non-variola orthopoxviruses using real-time PCR. If validated and approved, testing will be performed at ADCL’s CLEP/CLIA molecular diagnostics laboratory in Stony Brook, N.Y., utilizing its established and proven workflows to ensure accurate results and competitive turn-around-times.
“Based on our experience with the COVID-19 pandemic, we are keenly aware of the crucial role PCR-based diagnostic tools can play in responding and helping to control public health outbreaks. With a proven workflow and testing services born of COVID-19, upon test approval, ADCL stands ready to apply its testing capacity in service of New Yorkers’ health,” stated Dr. James A. Hayward, president and CEO of Applied DNA Sciences
https://investorshangout.com/recentnews/APDN#ixzz7aqrOlezh
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