If approved, the firm will get permission to manufacture the diagnostic kit intended to identify the genetic signature of the Clade II variant of the monkeypox virus
Applied DNA Clinical Labs has submitted a validation package to NYSDOH for approval for its monkeypox virus test. (Credit: Gerd Altmann from Pixabay)
Applied DNA Clinical Labs has submitted a validation package to the New York State Department of Health (NYSDOH) for approval for its monkeypox virus test.
ADCL, a subsidiary of Applied DNA Sciences, designed the test to identify the genetic signature of the Clade II strain of the monkeypox virus that is currently common in the US.
Submitted for full approval as a form of NYSDOH Laboratory Developed Test (LDT), the test will be used to power ADCL’s monkeypox testing services if approved.
If accepted by the NYSDOH, the test, known as the Linea Monkeypox Virus 1.0 Assay would be ADCL’s second successful LDT in less than a year.
The test is a component of the high-throughput infectious disease testing service provided by ADCL, which focuses on high-volume testing for infectious diseases that can recur within a community.
The Linea 2.0 COVID-19 Assay from ADCL, which now powers ADCL’s COVID-19 testing services, gained conditional clearance as an LDT from NYSDOH in January 2022.
If accepted, monkeypox testing will be carried out in ADCL’s Stony Brook, New York, CLEP/CLIA molecular diagnostics laboratory using tried-and-true procedures to guarantee accurate results and swift turnaround times.
Applied DNA president and CEO Dr James Hayward said: “Our pursuit of monkeypox testing via LDT combines what we believe to be the quickest regulatory path for diagnostic approval with our proven ability to deliver short turnaround time-to-results that, as Covid-19 has taught us, can help contain virus spread.
“Upon NYSDOH approval, ADCL has the testing capacity to deploy to help keep New Yorkers safe. Moreover, as the test kit manufacturer, we maximise the control over our own supply chain to ensure both quality and availability.”