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Dx Focus Nov 4, 2010: Clinical and Regulatory PCR and Nucleic Acid Testing News


Molecular Detection has been awarded a $244,500 federal grant to support the clinical development program for its Detect-Ready panel, which detects carriers of methicillin-resistant Staphylococcus aureus and related pathogens.

The grant was awarded under the Internal Revenue Service's Qualifying Therapeutic Discovery Projects program, which recently awarded around $1 billion in grants and tax credits to companies with technologies that "show significant potential to produce new and cost-saving therapies, support US jobs, and increase US competitiveness," the IRS said. The QTDP program was enacted as part of the federal Patient Protection and Affordable Care Act of 2010.

MDI's Detect-Ready panel is a qualitative real-time PCR in vitro diagnostic test that is marketed in the European Union and Australia and is in late-stage development in the US.

"Plans for our 510(k) validation trial are progressing well, with clinical sites on board and needed approvals in place," said Todd Wallach, CEO and chairman of MDI, in a statement. He added that the company hopes to begin marketing the system in the US next year.

Idaho Technology said this week that it has filed a submission with the US Food and Drug Administration for 510(k) clearance to market its FilmArray Respiratory Panel as an in vitro diagnostic product for patients with symptoms of upper respiratory tract infection.

The FilmArray RP is a multiplex PCR assay designed for the detection and differentiation of a panel of respiratory viruses and bacteria, including adenovirus, bocavirus, corona viruses, human metapneumovirus, influenza A and B viruses, parainfluenza viruses, rhino/entero viruses, respiratory syncytial virus, Bordetella pertussis, and Mycoplasma pneumoniae.

The company has several other clinical FilmArray applications under development, including a gastrointestinal tract panel, a blood culture panel, and sexually transmitted disease panel.

Seegene this week launched the Magicplex RV Panel Real-time Test, a multiplex test that identifies 29 respiratory viruses, including influenza A subtypes.

The company said that the test, which provides results in less than five hours, detects influenza A virus, influenza B virus, human respiratory syncytial virus A/B, human adenovirus A/B/C/D/E/F, human coronavirus 229E/NL63/OC43, human enterovirus, human rhinovirus A/B/C, human bocavirus 1/2/3/4, and human parainfluenza virus 1/2/3/4.

The company said that influenza A can be further analyzed into 2009 pandemic H1, human H3, and human H1 by using its Flu A Real-time Subtyping set.

The Magicplex RV Panel Real-time Test is based on the company's Real Amplicon Detection, or READ, technology, which combines a multiplex format with real-time PCR.

Magicplex tests are not approved for sale in the US.

The Scan

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