NEW YORK — TNG Dx said on Tuesday that it has partnered with Premier Medical Laboratories to develop a rapid RNA extraction protocol for use with SARS-CoV-2 diagnostics.
TNG Dx, a New York City-based startup focused on SARS-CoV-2 test and technology distribution, said that it has collected over 500 paired saliva samples using anterior nasal sampling at the Harris Country testing site near Houston, Texas.
The company said it has contracted Greensville, South Carolina-based Premier Medical to perform clinical and analytical validation studies to develop the extraction protocol, which will be submitted to the US Food and Drug Administration for Emergency Use Authorization by year end.
According to TNG Dx, the samples were collected in collaboration with laboratory testing coordinator eTrueNorth, which processes PCR-based SARS-CoV-2 tests under a contract with the US Department of Health and Human Services.
"The goal of this protocol is to develop a method to increase testing throughput for all open-platform qPCR machines with more comfortable, less invasive specimen collection that can be conducted by the patients themselves without medical personnel," Meghan Lockard, TNG Dx chief scientific advisor, said in a statement. "The protocol uses materials readily available in standard high and moderate complexity clinical laboratories. TNG Dx hopes that the universality of this protocol will facilitate rapid adoption in labs across the US."