Prodesse’s Multiplex RT-PCR
ProFlu+™ Assay Receives FDA Clearance
MILWAUKEE, WI (January 4, 2008) – Prodesse, Inc., the
leader in multiplex real-time PCR for infectious disease, announced
today it received 510(k) clearance from the U.S. Food and Drug
Administration (FDA) to market its ProFlu+™ Assay. The
clearance came in about two months from submission. ProFlu+
is a molecular diagnostic assay that, from a single specimen,
simultaneously detects and differentiates influenza A virus,
influenza B virus and respiratory syncytial virus (RSV). Not
only is it the first real-time molecular diagnostic test for
respiratory viruses to receive FDA clearance, but also it is
the first cleared real time molecular infectious disease test
to detect as many as three organisms simultaneously.
Because the ProFlu+ Assay uses real-time PCR (polymerase chain
reaction) technology, it is simple to use and easily integrates
into existing lab workflow. Real-time technology offers
clear advantages over other molecular diagnostic techniques such
as microbeads and microarrays because little hands-on time is
required, risk of amplicon contamination is eliminated, equipment
cost is relatively low and inducement concerns are minimized.
Because antiviral medications are most effective when given within
48 hours of symptom onset, it is important to have a test which
is both sensitive and timely. Results from the ProFlu+ Assay
are available in about 3 hours. The accuracy of the ProFlu+
Assay was confirmed in a multi-site clinical study comparing results
to traditional viral culture. A total of 826 patient samples were
prospectively tested and the assay demonstrated an overall clinical
sensitivity and specificity of 98% and 83%, respectively. The
decreased specificity was the result of the ProFlu+ assay detecting
more positive samples than culture. Further testing by genetic
sequencing determined that 87 of the 103 samples that were positive
by ProFlu+ but negative by culture were likely true positives.
“We are convinced that we made the right choice choosing real-time
PCR as our core technology platform,” said Tom Shannon, CEO. “Laboratorians
are telling us that the ‘big box’ multiplex systems are
cumbersome and more appropriate for epidemiological, not clinical,
applications. ProFlu+ is the first in a lineup of real time
respiratory assays that we are in the process of clearing. All
of these will use a common internal control so that a single nucleic
acid extraction can be used with multiple assays. Our Pro hMPV+™ for
detection of human metapneumovirus is currently in clinical trials,
and two additional products will shortly begin clinical trials: ProParaflu+™,
a multiplex assay for differentiating parainfluenza viruses and our
first enteric product, ProGastro™ Cd for Clostridium difficile.
With the new ASR guidelines finalized by the FDA in September, 2007,
it has become critically important for manufacturers to gain clearances
for their products. By implementing a strict design control
process, using skilled clinical trial site partners and working closely
with the FDA throughout the process, we hope to lead the industry
in earning 510(k) clearances for molecular diagnostic products.” |
About Prodesse
Prodesse is a biotechnology company focused on developing molecular
diagnostic reagents for a variety of infectious disease applications.
The company’s products are designed based on a combination
of Prodesse’s patented technologies and other licensed
technologies. Prodesse sells research use only kits worldwide,
CE Marked in vitro diagnostic kits outside the US , FDA 510(k)
cleared products worldwide and analyte specific reagents in the
US . Analyte specific reagents can be used by CLIA certified
laboratories to develop assays for detecting infectious organisms.
The company’s products can be used on multiple nucleic
acid extraction and PCR detection platforms. Prodesse also operates
a CLIA certified laboratory for testing services in the Midwest
area. For more information about Prodesse and its products, call
888-589-6974 or go to www.prodesse.com. |
