influenza
Quidel Receives FDA Clearance for Molecular Flu Assay for Use on Cepheid SmartCycler
Quidel Corp. has received 510(k) clearance from FDA for its Quidel Molecular Influenza A+B Assay for the detection of influenza A and B for use with Cepheid's SmartCycler PCR system. This product is one of several assays from Quidel's expanding molecular diagnostics programs. The Quidel Molecular product line offers PCR reagent kits for use by molecular diagnostic laboratories with their existing thermocyclers. These kits include features that provide for simple transport and storage, ease-of-...
GE, InDevR Developing POC Device for Flu Diagnosis
GE Global Research, GE's central technology development arm, has been awarded a program through the Defense Advanced Research Projects Agency (DARPA) to develop a medical device that can diagnose the flu and other infectious diseases such as malaria, E. coli and salmonella at the point-of-care. In addition to making an accurate diagnosis, another key goal of the device is to be readily adapted for new strains of diseases so that new diagnostic tests can be rapidly developed. GE scientists will...
BD Flu System Receives Regulatory Approval in Japan
Alverix announced that BD (Becton, Dickinson and Company) has received approval from the Japanese Ministry of Health, Labour, and Welfare (MHLW) for the BD Veritor System Flu A+B Test. The BD Veritor System was developed by BD which collaborated with Alverix for the development of the digital reader which employs Alverix’s near-patient testing platform. The BD Veritor System reader utilizes Alverix’s optoelectronic and signal detection technologies. The BD Veritor System delivers...
Alere Flu Test Receives CLIA Waiver
Alere Inc. received confirmation that FDA has cleared the Alere Influenza A&B Test for the U.S. market, categorizing it as CLIA-waived. This rapid test is intended for use in the physician’s office and will help healthcare practitioners manage patients with influenza-like illness more effectively. After multiple studies to validate the test and considerable collaboration with FDA, the Alere Influenza Test has been granted waived status. “We are very pleased to receive the CLIA...
Quidel Receives FDA Clearance for Molecular Flu Assay
Quidel Corp. has received 510(k) clearance from FDA for the sale of its molecular diagnostic test -- the Quidel Molecular Influenza A+B Assay for the detection of influenza A and B. This is one of several forthcoming assays from Quidel's expanding molecular diagnostics programs. The Quidel Molecular product line offers PCR reagent kits for use by molecular diagnostic laboratories with their existing Applied Biosystems 7500 Fast DX thermocycler. These reagents include attractive features...
BD Flu Detection System Receives 510(k) Clearance, CLIA Waiver
BD (Becton, Dickinson and Company) received 510(k) clearance and Clinical Laboratory Improvement Amendments (CLIA) waiver from FDA for the BD Veritor System for rapid detection of Flu A+B. This is the first rapid influenza test system that incorporates a digital read out of results to receive CLIA waiver. The BD Veritor System delivers good analytical sensitivity and specificity, offering healthcare professionals a new and different option in rapid influenza testing versus current...
Quest Diagnostics Announces Launch of Test for Flu, Respiratory Viruses
Quest Diagnostics Inc. announced the CE mark and European availability of the Simplexa Flu A/B & RSV Direct test on the 3M Integrated Cycler. The new test, from the company's Focus Diagnostics business, uses a proprietary technique to eliminate nucleic-acid sample extraction, a time-consuming process required by other molecular test products, for faster results reporting. "Simplexa Direct chemistry employs a novel technology that overcomes a critical limitation found in most molecular...
Researchers to Develop Screening Method for Superbug
A team of researchers from the University of Houston (UH) and St. Luke's Episcopal Hospital (SLEH) are working to develop improved screening methods to detect a potentially lethal, drug-resistant superbug that has made its way to Texas. Specifically, the research team looked at a multi-drug resistant bacterium called Klebsiella pneumoniae, which is increasingly resistant to most drugs of last resort. Commonly called CRKP, which is short for carbapenem-resistant Klebsiella pneumoniae, the...
New CDC-Developed Diagnostic Lab Test for Flu Approved
A laboratory diagnostic kit to diagnose human infections with seasonal influenza viruses and novel influenza A viruses with pandemic potential has been authorized for use by FDA. The IVD kit was developed by CDC. “As the spread of the H1N1 pandemic slowed last year, we conducted an end–to–end review of our nation’s medical countermeasure enterprise, which showed a clear need for better diagnostic tests,” said Dr. Nicole Lurie, assistant secretary for preparedness...
IQuum Receives FDA Clearance for Influenza Assay
IQuum Inc. has received FDA 510(k) clearance to market the Liat Influenza A/B Assay and the Liat Analyzer. This molecular diagnostic test is an automated sample-to-result multiplex real-time RT-PCR assay for the detection and discrimination of influenza A and influenza B in approximately 20 minutes. The test is intended for use in laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) to perform moderate complexity tests, enabling its use in hospital labs or other...