AltheaDx Launches World's First Assay To Test Quality Of RNA Isolated From FFPE Specimens

Main Category: Genetics
Also Included In: Medical Devices / Diagnostics
Article Date: 29 Mar 2009 - 1:00 PDT

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AltheaDx announced today the launch of RNA QC, a new service that informs clinical researchers of the accuracy of results from a patient's genetic test -- for diagnosis, prognosis or prediction of therapeutic response. The test is the world's first to examine the quality of RNA isolated from specimens that are preserved through formalin fixation and then paraffin embedded (FFPE), a process that severely degrades genetic material.

"Genetic tests offer tremendous promise but as with other tests, the quality of a result depends on the quality of the starting material -- garbage in, garbage out applies to molecular diagnostics as well," said David Macdonald, CEO of AltheaDx. "By understanding the quality of RNA extracted from a specimen, researchers and clinicians will have a key piece of information needed to interpret results from complex genetic tests and make informed decisions."

Over 90% of cancer patient specimens are FFPE. The process works well for preserving tissue used in microscope-based tests, but it works poorly for preserving genetic material used in molecular tests that offer diagnostic advantages over the microscope. Up until now, scientists have had no way of knowing the degree to which RNA or DNA is degraded in a patient FFPE specimen.

The AltheaDx RNA QC assay is based on proprietary multiplexed PCR technology, which simultaneously examines the integrity of nine different genes to determine the quality of RNA from a FFPE specimen. An algorithm then generates a predictive score of how well the RNA will perform on a subsequent PCR or microarray-based genetic test.

"Our RNA QC test provides a very efficient way to accelerate analysis and determine which samples will generate accurate results, versus samples which may be unusable," said Qiang Xu, Ph.D., Director of R&D and Informatics for AltheaDx. "Researchers conducting studies with FFPE specimens, companies developing new diagnostics, and oncologists making therapeutic decisions will benefit from this information. Ultimately, the patient will benefit most from more informed therapeutic decisions."

About AltheaDx

AltheaDx is bringing theranostics into clinical use. The goal of AltheaDx is to reduce the time and risk of therapeutic development and to provide high-value testing services. For additional information, please visit: http://www.altheadx.com.

Source
AltheaDx