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Courtagen Submits Pre-IDE to FDA for C-reactive Protein Technology

NEW YORK (GenomeWeb News) – Courtagen Life Sciences today said it has submitted its first pre-investigational device exemption information package to US regulators for its automated solution for measuring C-reactive proteins in a clinical setting.

In addition to its submission to the US Food and Drug Administration, Courtagen is pursuing a CE Mark for the solution, which is comprised of its Avantra Q400 BioMarker Workstation and the QPDx BioChip.

Use of the QPDx BioChip CRP Assay on the AvantraQ400 Biomarker Workstation is intended for the in vitro quantitative measurement of CRP concentration in serum or plasma in a clinical laboratory or point-of-care setting, the Woburn, Mass.-based company said.

CRP is produced in the liver and elevated levels indicate a heightened state of inflammation in the body. Measuring CRP levels can be useful in determining disease progress or the effectiveness of a treatment, Courtagen said.

The firm's technology addresses "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," Courtagen President Brendan McKernan said in a statement. "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."

Courtagen was founded in 2009 from the assets of the now-defunct Decision Biomarkers and raised $8 million during the fall and $7 million in 2010. In January, Courtagen purchased Medicinal Genomics, a firm researching the genomics and medicinal use of marijuana.

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