Products




	The first cleared real time molecular diagnostic test for respiratory viruses! The only molecular test for influenza so sensitive that FDA does not recommend culture backup!

Transmission electron micrograph (TEM) depicting the ultrastructural details of an influenza virus particle, or “virion”. Courtesy of CDC/Public Health Image Library

An easy-to-use kit including all primers, probes, buffers and enzymes.

Just add water! (molecular grade)

Influenza A Virus
Influenza B Virus
Respiratory Syncytial Virus
Internal Control

Fact Sheet

Package Insert/Instructions for Use

Revision History

Prodesse Press Release (initial clearance)

FDA Press Release

Prodesse Press Release
(adding easyMAG™, elimination of culture backup for influenza)

Performance Data

Poster by Albany Medical Center at 2008 Clinical Virology Symposium

Poster by Johns Hopkins at 2008 Clinical Virology Symposium

Publications

ProFlu+ received 510(k) clearance from the FDA on January 4, 2008, making it the first real time multiplex RT-PCR to achieve this milestone.
On May 2, 2008, FDA cleared the addition of the easyMAG™ extractor and the removal of the culture backup recommendation for influenza viruses.

ProFlu+ is an upgraded version of Prodesse’s highly regarded ProFlu-1™, which has been discontinued from sale. Papers for ProFlu+ are not yet available, but quite a few (listed below) have been published for ProFlu-1.

Paper by Hôpital Européen Georges Pompidou in December, 2007 Journal of Clinical Microbiology

Paper by Cleveland Clinic in January, 2007 Infectious Diseases in Clinical Practice

Poster by Cleveland Clinic at 2006 Clinical Virology Symposium

Poster by Erie County Medical Center at 2006 Clinical Virology Symposium

Poster by Lahey Clinic at 2005 Clinical Virology Symposium

Electron micrograph of hMPV
Source: Prof. Paul K S Chan, Dept of Microbiology, The Chinese University of Hong Kong Copyright retained, no unauthorized uses

Human metapneumovirus

Includes enzymes

Uses the same internal control as ProFlu+, so that a single nucleic acid extract can be used in both assays

Fact Sheet

Package Insert/Instructions for Use

Revision History

Publications

Companies licensed by ViroNovative (hMPV patent holder)

Poster by Dallas Children’s at 2008 Clinical Virology Symposium

Pro hMPV+ has replaced Pro hMPV. We have made the product easier to use by including enzymes. ProFlu+, Pro hMPV+, ProParaflu+ and ProAdeno+ will all use a common internal control strategy. This enables researchers to use a single nucleic acid extract for all four assays.
Pro hMPV is no longer available, but two posters describing it have been published.

Poster by Prodesse at 2006 ASM

Poster by Cleveland Clinic at 2006 Clinical Virology Symposium

The following products are in various stages of the FDA clearance process. They have not yet been cleared for marketing by the FDA.

Electron micrograph of parainfluenza virus Courtesy of CDC/Public Health Image Library

Parainfluenza 1 Virus
Parainfluenza 2 Virus
Parainfluenza 3 virus

Includes enzymes

Uses the same internal control as ProFlu+ and Pro hMPV+, so that a single nucleic acid extract can be used in these assays

Clinical trials are currently underway. Submission to FDA for 510(k) clearance is expected in Spring, 2009.

Micrograph of Clostridium difficile. Courtesy of CDC/Public Health Image Library

Toxigenic strains of Clostridium difficile

Includes enzymes

Clinical trials have been completed. Submission to FDA for 510(k) clearance is expected in early 2009.