Courtagen Submits Pre-IDE Information Package for the Avantra® Q400 Workstation and QPDx® BioChip
WOBURN, Mass., May 09, 2012-- Courtagen Life Sciences, Inc., a privately held life sciences company that provides innovative proteomic and genomic products and services to the life sciences industry, today announced that the company has submitted its first pre- IDE (Investigational Device Exemption) information package to the U.S. Food and Drug Administration for the Company’s Avantra® Q400 BioMarker Workstation and QPDX® BioChip for the measurement of C-reactive protein (CRP). Courtagen is also pursuing a CE Mark Approval for the European Union.
Using the Avantra® Q400 Biomarker Workstation, the QPDx® BioChip CRP Assay is intended for the in vitro quantitative measurement of CRP concentration in serum or plasma, in either a clinical laboratory or point-of-care setting. CRP, a protein produced in the liver, is a "marker" for inflammation, meaning elevated concentrations indicate a heightened state of inflammation in the body. Inflammation is a normal response to many physical states including fever, injury and infection. Measuring and charting CRP values can prove useful in determining disease progress or the effectiveness of treatments.
“With unparalleled performance, reliability and speed, Courtagen’s protein biomarker technology is addressing a significant need in the healthcare and research marketplace: assay sensitivity and sample utilization that maximizes both dynamic range and clinical utility, all in a simple one step, walk away format,” said Brendan McKernan, President of Courtagen Life Sciences. “We are actively working with diagnostic partners to develop novel diagnostic tests for critical care needs, and are committed to delivering this breakthrough technology to the point-of-care in order to meet the needs of our customers, clinicians, and ultimately patients.”
The QPDx® BioChip is a fully self-contained multiplex protein immunoassay. The
QPDx® BioChip can be used for biomarker analysis in areas such as oncology, wound
healing, a variety of inflammatory disorders, and sepsis. In addition, Avantra Biosciences
offers custom development of disease-specific BioChips designed to fit individual testing
The Avantra® Q400 Biomarker Workstation and QPDx® BioChip provide a fully
automated solution for the accurate measurement of CRP in a clinical setting. With
minimal sample preparation and simple one button automation, this system provides
timely results without the need for highly trained laboratory personnel. Each QPDx®
BioChip contains a positive control and a negative control that fulfill the requirement for
daily laboratory controls.
The pre-IDE process is essentially a "pre-submission" that may involve sending
analytical or clinical protocols to the FDA for review and comment before proceeding
with studies. The process is designed to help companies obtain early, informal input on
aspects of a future IDE application and offers assistance in establishing the parameters
for official IDE applications when unique diagnostic tests involving innovative
technologies are being pursued. Pre-IDE submissions are strictly voluntary, and any
comments or recommendations made in the review of protocols during these meetings are
not binding for the Agency or the Sponsor.
About Courtagen Protein Diagnostics
Courtagen has developed a next-generation, POC protein biomarker technology, called
the Avantra®® Q400 Biomarker Workstation and QPDx® BioChip. This technology is
ideal for users who operate in a decentralized environment, and require on-demand
testing of biomarkers. The protein diagnostics technology provides users with an
integrated system that automates sample processing, reagent handling, biomarker
detection, and analysis. This unmatched simplicity minimizes user error, and affords
precision with limited operator training.
About Courtagen Life Sciences, Inc.
Courtagen Life Sciences is a privately held life sciences company that provides
innovative proteomic and genomic products and services to the life sciences industry.
Founded by innovators in next-generation sequencing (NGS), genetics, molecular
biology, and information science, our company delivers tools that enable researchers and
clinicians to make better decisions regarding drug development and patient care.
Courtagen provides proteomic and genomic solutions through its various operating
divisions. More information can be found at www.courtagen.com.
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