Applied BioCode announced today that it has received Emergency Use Authorization (EUA) from the US FDA for the use of its BioCode® SARS CoV-2 molecular diagnostic assay with pooled patient samples*. Applied BioCode’s EUA permits the pooled testing of up to five individual specimens from patients suspected of having COVID-19. The BioCode® SARS CoV-2 Assay is run on the automated BioCode® MDx-3000 Molecular System. With “pooled sampling” the system can test 2,820 samples per day.
The FDA is authorizing pooled-sample testing as more efficient than individual testing, meaning that fewer testing supplies are used and more tests can be run at the same time and in most cases, this allows patients to receive their test results more quickly. Pooled testing is most efficient in areas with low prevalence, meaning most results are expected to be negative. As a condition of authorization Applied BioCode has agreed to conduct additional pooled sample testing at three different clinical sites.
“By providing a pooling protocol, we are helping our clinical laboratory customers meet the high demand for accurate high volume molecular test results during the pandemic,” said Applied BioCode’s President Winston Ho, Ph.D. “This amendment to our Emergency Use Authorization for COVID-19 testing from the US FDA for pooling samples will enable more samples to be tested each day, allowing test results get back to patients faster. I am very proud of the accomplishments our team has made in getting these important tests to laboratories in the fight against this virus.”
The BioCode® SARS-CoV-2 Assay is designed to provide accurate results by detecting two different regions of the SARS-CoV-2 virus N gene. The assay can be run as an independent assay or in parallel with our FDA-cleared BioCode® Respiratory Pathogen Panel for a more complete respiratory infection profile of patients.
For more information on the BioCode® SARS CoV-2 Assay, visit: www.apbiocode.com
About Applied BioCode
Applied BioCode is an IVD manufacturer that designs, develops, and commercializes multiplex testing products. The company has combined “digital barcodes” with immuno- and molecular chemistry to create a new, bio-inspired Barcoded Magnetic Beads (BMB) technology. The micro BMBs, about the diameter of a human hair, are tagged with immunochemistry or molecular probes, allowing the digital barcodes to be easily scanned and accurately identified up to 4,096 barcodes with no ambiguity for biological targets. The company is FDA-510K cleared for their Respiratory 17-plex Pathogen Panel and Gastrointestinal 17-plex Pathogen Panel based on their BioCode® MDx-3000 automated system. Applied BioCode also partners with a variety of diagnostic companies with applications that include the infectious disease, autoimmune disease, allergy, gut microbiome, and veterinary markets.
* This test has not been FDA cleared or approved. This test has been authorized by FDA under an EUA for use by authorized laboratories. This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21. U.S.C. § 360bbb3(b)(1), unless the authorization is terminated or revoked sooner.
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