At present, the BT-MED COV19 Test is for use only in CLIA-high-complexity laboratories.
Escher Biomedical Diagnostics, LLC announced that its Escher BT-MED® COV19 Saliva Test has been accepted by FDA as a Notification under Section IV.C of the Emergency Use Authorization program. The BT-MED® COV19 Test system is a high-throughput molecular method for detecting infection by the SARS-CoV-2 virus in specimens of saliva from individuals suspected of COVID-19 by their healthcare provider.
Through this Notification, Escher indicates its intent to distribute the COVID-19 virus test in the US while FDA review of the EUA request is pending. At present, the BT-MED® COV19 Test is for use only in CLIA-high-complexity laboratories.
“We are pleased to introduce this important method to the detection and characterization of pathogens. The novel approach developed by Biotrack BV allows fast and accurate detection of the COVID-19 virus within infected human cells that appear in saliva,” stated Phil Speros of Escher. “And there are many advantages to saliva as a specimen, such as simplicity of collection, but also the ability to verify correct sample collection simply by observing the presence of the necessary small volume. These are important advantages over swab-based methods.”
The BT-MED® diagnostic device is based on in situ hybridization with fluorescent molecular probe, coupled with automated intelligent digital image processing that evaluates as to the presence or absence of the virus. “There is no ‘RT’ and No ‘PCR’ because the BT-MED® COV19 method uses alternate methods to amplify the signal due to the virus.”
Gerard Schouten, CEO of Biotrack BV, the manufacturer of the test system, comments, “After years of development our technology has come of age as a robust device that is simple to deploy and implement, even to challenging settings such as trucks and ships. Implementation in a clinical laboratory is easy.” Schouten continued, “The fact that our system directly observes the molecular probe-lit viral nucleic acids in the infected human cells [shed in saliva] made it possible to create automated software to determine whether there is an infection or not.”
The BT-MED® system is composed of the BT-MED® Analyzer and test kits associated with specific pathogens or panels of pathogens. The Analyzer can be configured for full automated use, which minimizes the need for human technical activities, or partial automated use, which allows higher throughput.
The BT-MED® Analyzer and BT-MED® COV19 Test Kit is also CE Marked.
Source: Company Press Release