Skip to main content
Premium Trial:

Request an Annual Quote

Idaho Tech's PCR-Based Biothreat Detection System Wins AOAC Certification


Idaho Technology said this week that its Razor EX BioThreat Detection System has received approval and certification as an AOAC performance-tested method for detecting Bacillus anthracis spores collected from the air on filter or liquid matrices.

The Razor EX comprises a DNA extraction kit, a freeze-dried PCR reagent pouch, and a real-time PCR instrument. Each pouch contains three PCR assays, which distinguish potentially virulent B. anthracis from non-lethal B. anthracis and other Bacillus species.

The validation process consisted of three phases: evaluation by the method developer; testing by an independent laboratory; and collaborative testing by 12 independent operators. During the first two evaluation phases, 2,473 of 2,479 samples tested provided 99 percent success with 95 percent confidence, Idaho Tech said.

The platform is the first and only system to successfully pass this evaluation process, Idaho Tech said. The certification is part of a Department of Homeland Security-sponsored program with AOAC International and the AOAC Stakeholder Panel on Agent Detection Assays, or SPADA, to establish a national program for testing and validating biosurveillance systems to provide guidance to first responders, public health, and government agencies in procuring equipment.

The Scan

Study Follows Consequences of Early Confirmatory Trials for Accelerated Approval Indications

Time to traditional approval or withdrawal was shorter when confirmatory trials started prior to accelerated approval, though overall regulatory outcomes remained similar, a JAMA study finds.

Sequencing Study Leads to Vaccine Target in Bacteria Behind Neonatal Meningitis

Researchers eBioMedicine track down potential vaccine targets with transposon sequencing on mutant bacteria causing neonatal meningitis in mouse models of the disease.

Multiple Myeloma Progression Influenced by Immune Microenvironment Expression

Researchers in NPJ Genomic Medicine compare RNA sequencing profiles of 102,207 individual cells in bone marrow samples from 18 individuals with rapid or non-progressing multiple myeloma.

Self-Reported Hearing Loss in Older Adults Begins Very Early in Life, Study Says

A JAMA Otolaryngology — Head & Neck Surgery study says polygenic risk scores associated with hearing loss in older adults is also associated with hearing decline in younger groups.