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Lab21, IntegraGen to Develop PCR-Based Assay to Guide Colorectal Cancer Therapy

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UK-based clinical diagnostics developer Lab21 said last week that it has inked an agreement with IntegraGen to develop a microRNA assay for colorectal cancer designed to improve patient outcomes.

Under the agreement, Lab21 will develop a CE-marked assay using its proprietary SPARQ PCR technology to detect expression levels of a microRNA biomarker called hsa-mir-31-3p, which was discovered and patented by IntegraGen and its academic partners.

Early research has shown that this biomarker may predict response to EGFR inhibitor therapy in KRAS-wild type patients who have metastatic colorectal cancer.

Financial details were not disclosed. Following development of the hsa-mir-31-3p assay, Lab21 and IntegraGen will explore other partnering opportunities to manufacture and commercialize the biomarker, Lab21 said.

Lab21's SPARQ technology "circumvents the use of other primers and probes weighed down by expensive licensing costs" and enables "time- and cost-efficient development and manufacture of very sensitive and specific real-time PCR assays suitable for any real-time PCR platform," according to the company's website. The company has not disclosed additional details about the technology.

The agreement with IntegraGen is Lab21's second disclosed partnership in the personalized medicine space. In October, Becton Dickinson's Diagnostics unit said that it was collaborating with Lab21 to develop oncology assays initially targeting the KRAS and BRAF mutations for use on the BD Max molecular diagnostics system.

Lab21 also has a partnership in place with BD Diagnostics to develop a BD Max assay for Aspergillus fungal infections (PCR Insider, 8/4/2011); and has a similar assay-development deal with an undisclosed IVD company (PCR Insider, 4/12/2012).

Lab21 also has a portfolio of its own real-time PCR assays for fungal disease diagnostics under the Myconostica brand; and has a pipeline of oncology molecular diagnostic products in development, due to launch this year under the Onconostica brand name, according to the company's website.

The Onconostica products include an agreement with an undisclosed pharmaceutical company to develop, manufacture, and distribute a new companion diagnostic assay.

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