LGC eBook - 2017 - 20

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

FDA-cleared, and the influenza test received
a CLIA waiver in May 2015.
The Liat analyzer achieves its speed primarily
through a PCR procedure (flow cycling). PCR
machines have typically consisted of a large
heating block, housing one or more reaction
tubes, that cycles its temperature to achieve
the target denaturing, annealing, and extension
temperatures, a process requiring between 30
minutes and several hours to complete.
The Liat, however, uses a flexible reaction
vessel and a modular sample processor, which
compresses various segments of the reaction
vessel to heat and cool them much faster,
allowing results in as little as 20 minutes.
In the cardiovascular space, Spartan Biosciences
announced October 2014 that it had received
approval from Health Care Canada for its
Spartan RX CYP2C19 system, a genetic test
that can determine whether patients receiving
the antiplatelet medication clopidigrel (Plavix)
following percutaneous coronary intervention
20

| GENengnews.com

(PCI) have CYP2C19 mutations that may
impair their ability to metabolize the drug. The
CYP2C19*2 allele is a common genetic variant
associated with increased rates of major adverse
events in individuals given Plavix.

prospective, randomized, proof-of-concept
study using the genetic test to identify carriers
of the CYP2C19*2 allele and aimed to assess a
pharmacogenetic approach to dual antiplatelet
treatment after PCI.

The Canadian approval for the test follows the
FDA's 510(k) clearance of the test in August
2014, indicated for use as an aid to clinicians in
determining strategies for therapeutics that are
metabolized by the cytochrome P450 2C19 gene
product, and that are specifically affected by the
*2, *3, and *17 alleles. The agency also noted that
in the U.S., the device must be used in a clinical
lab and is not cleared for POC use.

Patients undergoing PCI for acute coronary
syndrome or stable angina were randomly
assigned to rapid POC genotyping or to standard
treatment. Individuals in the rapid genotyping
group were screened for the CYP2C19*2 allele.
Carriers were given 10 mg prasugrel daily,
and noncarriers and patients in the standard
treatment group were given 75 mg clopidogrel
daily. The authors reported that, based on their
results, POC genetic testing after PCI can be
done effectively at the bedside, and treatment of
identified CYP2C19*2 carriers with prasugrel can
reduce high on-treatment platelet reactivity.

Spartan says its RX CYP2C19 System is the first
near-patient DNA test for personalized medicine
that has been approved in Canada. Health
Canada also approved its use by healthcare
professionals, including doctors, nurses,
pharmacists, and laboratory technicians in
medical care sites and clinical labs. The device
was validated by Spartan and reported in The
Lancet. The study enrolled 200 patients in a

While the majority of miniaturized systems for
nucleic acid analysis use PCR for amplification,
newer devices in development may provide truly
POC results, in particular isothermal amplification
methods that do not require thermal cycling.

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LGC eBook - 2017

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