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Idaho Tech Simultaneously Seeks CLIA Waiver for FilmArray, FDA OK for Respiratory Panel

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By Bernadette Toner

Idaho Technologies said this week that it has been awarded a $3.3 million grant from the US Defense Threat Agency to help it continue developing its FilmArray PCR platform.

The company plans to use the grant to pursue a Clinical Laboratory Improvement Amendments waiver from the US Food and Drug Administration that will enable the system to be used in non-CLIA labs by operators without technical training.

Philip Maggi, vice president of external affairs at Idaho Technology, told PCR Insider via e-mail that the company is seeking the CLIA waiver concurrent with FDA clearance of the FilmArray and a respiratory panel that it has designed to identify and detect 22 upper respiratory diseases.

The respiratory panel, currently available for research use only, can detect adenovirus; bocavirus; coronavirus 229E, HKU1, OC43, and NL63; influenza A, A H1, A H1 2009, A H3, and B; metapneumovirus; parainfluenza 1, 2, 3, and 4; respiratory syncytial virus; and rhinovirus. It also detects Bordetella pertussis, Chlamydophila pneumoniae, and Mycoplasma pneumoniae.

"Though the FDA trial and CLIA waiver study are occurring simultaneously, the CLIA waiver certification will occur after the system is FDA cleared," Maggi said.

The grant, awarded by DTRA on behalf of the US Air Force Assistant Surgeon General, Modernization Directorate, supports a two-year study to achieve CLIA waiver status. However, Maggi noted that the firm is "working closely with both commercial and government partners to reduce the time to market in any way possible."

He noted that the "primary focus" of the FilmArray is the commercial market, but said that along with the CLIA waiver study, "the military is performing a military utility evaluation on the system for specific military uses."

The FilmArray platform integrates sample preparation, PCR amplification, detection, and analysis into a single system that the company said can detect more than 100 targets per sample in under an hour. The instrument weighs around 20 pounds and measures 10 in. by 15.5 in. by 6.5 in.

The key to the system is a "pouch" that includes all reagents for sample prep, RT-PCR, PCR, and detection in a freeze-dried format. An operator adds water and unprocessed sample into the pouch and the system automatically extracts and purifies nucleic acids from the sample, performs a nested multiplex PCR in two stages, and then generates a result for each target.

Idaho Technologies said in a statement that currently "no technology for pathogen identification exists that is capable of identifying numerous pathogens simultaneously, has integrated sample preparation, occurs in less than an hour, and is CLIA-waived for use by novice laboratory personnel."

Maggi said that the company does not expect to have to make any changes to the system to gain the CLIA waiver, noting that it was "designed to be easy to use and run by any trained operator," and includes "multiple system performance checks."

The CLIA-waived FilmArray system will test for common and emerging respiratory pathogens, and will "provide the military a near real-time force protection capability," Kirk Ririe, CEO of the company, said in a statement.

Maggi said that in addition to pathogen-detection applications, the company is evaluating other applications for the CLIA-waived FilmArray system in epidemiology, genetics, and drug discovery.

Idaho Technologies said that in a study conducted by Johns Hopkins University's Applied Physics Laboratory in March that evaluated 164 instrument systems, the FilmArray was found to be the only platform that met the biodefense needs of the Department of Defense.

The company could not provide further details of the study.

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