Dr. Austin Tanney and his colleagues at Almac Diagnostics have developed a custom microarray to discover and validate clinically applicable expression biomarkers from the often degraded RNA in formalin-fixed paraffin-embedded (FFPE) samples. The one billion FFPE samples currently in biobanks represent a goldmine for clinical research, particularly for many types of cancers. The Almac team regard such FFPE samples, backed up by extensive clinical annotation and clinical outcomes, as critical to the success of personalized medicine, particularly in oncology.
The team's focus has always been the development of clinically applicable, genomic-based diagnostic tests. The tools to do this, especially in FFPE tissues, were not available when they began this work. They chose to work with Affymetrix because the GeneChip® instrument system has a FDA-cleared and CE marked version. Their initial studies yielded better signal from the 3' end of the transcript. Therefore, to maximize data acquisition from FFPE samples, the team designed their custom array, based on GeneChip® Human Genome U133 Plus 2.0 Array, to include additional probes focusing on the last 300 bases of the transcript.
Almac Diagnostics has two array-based diagnostic tests at the forefront of their development pipeline. With high-complexity diagnostic and prognostic tests already on the market, Tanney anticipates that molecular testing will become widely accepted in the next few years.
Read the full story ›