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Frost & Sullivan: Expanding Sample Prep Market Supports Growth Trends in Molecular Diagnostics Markets
Date:6/21/2012

Process automation signals the brink of a market expansion fueled by the increased throughput.  Additionally, clinical molecular tests for serine/threonine-protein kinase B-Raf (BRAF) and GTPase Kras (KRAS) gene biomarkers, as well as for epidermal growth factor receptor (EGFR), are driving the demand for the FFPE sample preps.

Sample prep for FFPE specimens that produce nucleic acid extractions of high purity and yield will become even more critical for downstream molecular testing. The clinical labs surveyed by Frost & Sullivan anticipate an inevitable integration of molecular extraction techniques with the long FFPE legacy that exists in solid tumor diagnostics.

However, growth of this market is hindered by the limited number of sites where molecular pathology is performed as well as the slow adoption of FFPE sample prep automation by hospital laboratories. Further, hospital budgets are restricted, and investments for FFPE sample prep automation compete with other top priorities, such as the implementation of electronic medical records. Despite these factors, the hospital segment is far from saturation, as it has long-term potential.

The FFPE sample prep automation market targets a variety of end user segments with different needs, applications, and perceptions; therefore, a strong understanding of relevant product specifications is critical for capitalizing on the market opportunity. Vendors must remain attentive to genomic analysis trends and emerging applications to keep pace with changing customer needs in specimen types, protocol customization and throughput.

"Since the larger application segment for the FFPE sample prep automation market is research on FFPE archival specimens, FFPE sample prep vendors should align their products with the pricing and technological needs of customers in this segment," said Tan. "Vendors could serve more customer segments by offering multiple automation systems that vary in batch size and
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