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Courtagen Submits Pre-IDE Information Package for the Avantra Q400 Workstation and QPDx BioChip

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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 needs.

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.

Source: Courtagen Life Sciences