LGC eBook - 2017 - 18

Accelerating Science Using Integrated PCR Tools * Point-of-Care Molecular Diagnostics Evolve

including the NIH, the DOD, private foundations like the Bill & Melinda Gates
Foundation, and the pharmaceutical industry.
In April 2015, Roche bought POC molecular testing company IQuum
for $275 million in cash and the potential for an additional $175 million in
milestone payments. The Marlborough, MA company has FDA-cleared and
CE-marked diagnostic tests that can be performed at the POC site with
minimal training.
While historically focused on infectious diseases that affect developing nations,
molecular POC has rapidly advanced into other clinical areas, including monitoring of cardiac disease patient drug responses and, most recently, Cepeheid's
GeneXpert (Xpert) test for BCR-ABL, a real-time RT-PCR that can aid in monitoring
the p210 BCR-ABL translocation, producing results in less than two hours.
Key technological factors contributing to the favorable funding climate and
interest in developing molecular POCs include advances in microfluidics and
other instrumentation technologies that can enable development of relatively
low-cost platforms and tests that meet the needs of a true POC system.
Specific challenges associated with developing POC molecular tests include
the additional steps for sample pretreatment (e.g., cell sorting, isolation, and
lysis), the requirements for nucleic acid extraction and signal amplification,
sample-prep integration with a complete analytical process that does not

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| GENengnews.com

POC molecular testing technologies garnered more than $650
million in investments and financings between 2009 and 2013.
iStock/BlackJack3D
http://www.GENengnews.com
LGC eBook - 2017

Table of Contents for the Digital Edition of LGC eBook - 2017
