Exiqon validates blood plasma-based miRNA PCR test for early detection of colorectal cancer
27-10-11 kl. 27/10 2011 07:01 | Exiqon 17,80 (0,00%)
Exiqon A/S (NASDAQ OMX Copenhagen: “EXQ”) today announced the presentation of
data at the 2011 EORTC-NCI-ASCO meeting in Brussels providing initial
validation of the company's blood plasma-based miRNA PCR test for early
detection of colorectal cancer and associated quality control criteria for the
multicenter blood samples used to develop the test.
The validated miRNA signature reaches 82% sensitivity for detection of cancer
at 89% specificity with an area under the ROC curve of 0.87. In addition to the
improved sensitivity (initial discovery data for sensitivity was 75%) and
specificity (initial discovery data for specificity was 80%), the validated
miRNA signature is simple and robust enough to allow for the development of a
PCR Kit for early detection of colorectal cancer
Further studies are ongoing to complete the retrospective validation by year
end and data will be available for publication by end Q1 2012. Exiqon expects
to commence a large prospective validation study based on several thousands of
individuals early 2012.
“This first data validates a simple and robust miRNA biomarker profile that can
be derived from blood plasma obtained from a multicenter study under standard
clinical conditions. This represents a great breakthrough for Exiqon. We have
developed our proprietary miRCURY LNA™ Universal RT microRNA PCR system for
fast and robust miRNA profiling of blood samples, and we can now demonstrate
how this platform may be used to address a large unmet diagnostic need. The
technology and procedures may be applied not only for early detection of
colorectal cancer but also for other diagnostic applications in the field of
oncology and beyond” says Lars Kongsbak, CEO of Exiqon.
Exiqon is collaborating with 7 Danish hospitals which are collecting up to
10,000 blood samples from individuals who are also undergoing colonoscopy to
develop a molecular diagnostic test based on miRNA profiling of blood plasma
for early detection of colon and rectal (colorectal) cancers. The data
published today is based on 325 blood samples from 7 hospitals of which only
samples from 5 hospitals passed the QC criteria making up a total of 156
samples for the initial validation. The established QC procedures allowed for
identification of a disproportionate number of samples obtained from two
hospitals failing QC demonstrating the relevance and adequacy of the
established QC procedure that overcomes the challenge of haemolysis (the lysis
of red blood cells) of blood samples which may jeopardize accurate diagnosis.
Exiqon's proprietary PCR system only requires 100 µl of plasma sampled under
standard clinical conditions and allows for testing to be completed in a few
hours including QC procedure.
The established miRNA biomarker signature and associated quality control
procedures are subject to separate patent filings. For more information, please
visit the abstract page of the 2011 EORTC-NCI-ASCO Meeting home page at:
http://www.eortc.be/seminar/enasco2011/default.htm
See the full announcement in the attached PDF.
Additional information:
Lars Kongsbak, President and CEO, tel. +45 4566 0888 (cell: +45 4090 2101)
Hans Henrik Chrois Christensen, CFO, tel. +45 4566 0888 (cell: +45 4090 2131)
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Announcement_Oct2011_ASCO_EORTC_final.pdf 



