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IVD is a rising oncology star
July 2013
EDIT CONNECT
SHARING OPTIONS:
ROCKVILLE, Md.—Noting that the market for cancer diagnostics
was $4.8 billion in 2012 and is on track to reach $7.3 billion by 2017—given an
average
annual growth rate of 9 percent—medical and healthcare market research
firm Kalorama Information says that cancer testing is "maturing from
personalized medicine to precision medicine, where protein and
molecular
biomarkers are essential for precise diagnosis, therapy selection, therapy
monitoring and early detection of cancer recurrence."
That statement and the monetary projections are part of
Kalorama's report titled "The World Market for
Cancer Diagnostics, 5th Edition:
Precision and Personalized Testing Arrives," which contains detailed market
data on in-vitro diagnostic
(IVD)
products for their use in cancer diagnostics in the segments of
histology/cytology, immunoassays, flow cytometry, rapid tests, molecular
assays, tissue arrays, circulating tumor cells and molecular
pharmacodiagnostics.
One of the
more interesting developments in cancer testing,
according to Shara Rosen, Kalorama Information analyst and author of the
report, is multiplex testing,
which includes such technologies as bead arrays,
electrochemical arrays, Invader, microarrays, SNP-it and WAVE—all of them
technologies that have the
flexibility to be used for clinical and research
applications, she notes.
"The major companies—Affymetrix and Illumina—are developing
clinical applications for their biochip and array platforms and have
established CLIA-certified labs to validate multiplexed assays for routine
use," Rosen says. "Finding the competition a bit too hot, and having other
molecular opportunities, Roche Diagnostics has decided
to exit the microarray
market. The company's NimbleGen product line is now distributed by
PerkinElmer."
Rosen says that the goal for
clinical biochips or
lab-on-a-chip devices is to include sample preparation, injection and
detection, with all the work done in just a few minutes.
"Thus, biochips make a perfect match for the new wave of
tests that rely on gene and protein
expression patterns," Rosen notes, saying
that for the purposes of the Kalorama report, "biochip" is meant to refer to
all testing devices that
involve multiplexed biosensors, microfluidics and
microarrays. "The devices have evolved and have been developed to miniaturize a
variety of
diagnostic technologies—nucleic acid amplification and detection,
chromosome analysis, immunoassays, mass spectrometry, flow cytometry and
sequencing.
Biochip technology is expected to have a significant impact on
molecular diagnostics, especially since several biochip instruments have been
cleared
for use for IVDs."
Some of those instruments include Affymetrix's GeneChip
System 3000Dx v.2
and Transgenomic's WAVE Microchip Electrophoresis system.
Several chip-based tests have come to market, Rosen adds, and several are used in
lab services for cancer detection and therapy selection, with still
more in
development.
"There are only five FDA-cleared molecular diagnostic
products, of which
three are for cancer diagnostics," Rosen notes. "Roche's
AmpliChip, Agendia's Mammaprint, Osmetech's cystic fibrosis test,
Vermillion's
OVA1 ovarian-cancer test and Pathwork Diagnostics' Tissue of Origin test."
It should be
noted that since the gathering of data for the
Kalorama report, Pathwork now seems to be defunct, and market-watchers note
that the future of the
Tissue of Origin test is unclear.
Rosen also noted that Ipsogen SA (now known as QIAGEN
Marseille) is leading the way in CE-marked DNA microarrays for clinical
diagnostics.
Ipsogen has built a portfolio 21 kits, of which 10 are
CE-marked, Rosen says, since its founding in
1999, and it has developed and
commercialized "unique molecular tools for patient risk stratification, to
predict patient response to treatment and to
monitor minimal residual disease
for hematological malignancies." From this proof of concept, she says, Ipsogen
is now leveraging its expertise to
address molecular diagnosis of solid tumors,
such as breast and colon cancer.
Rosen also thinks
the digital PCR (dPCR) space is
interesting right now, in part because dPCR has been shown to be better than
many existing technologies at detecting
subtle differences between samples with
similar genomic structures.
"This is especially
important in determining drug targets
for pharmacodiagnostic testing and stratifying disease," Rosen says. "At this
time, no dPCR systems have been
cleared for clinical diagnostics; they are used
in cancer research."
In 2006, she notes, Fluidigm introduced the first commercial
system for dPCR based on
integrated fluidic circuits, and in November 2010,
Life
Technologies commercialized a dPCR product line for the OpenArray system.
In March 2010, QuantaLife—which was acquired by Bio-Rad Laboratories in October
2011—was issued a patent for dPCR based on
emulsions, leading to its droplet
digital PCR technology to convert a DNA sample into 20,000 1-nL droplets.
TaqMan-based amplification takes place in
each droplet, Rosen explains,
followed by absolute quantitation of the number of copies of a gene target as
the individual droplets stream past a
fluorescence detector.
"QuantaLife reported that its system is capable of detecting
DNA targets with
absolute quantitation," Rosen says. "Droplet digital PCR can
achieve 10 times higher resolution and 25 times greater sensitivity than
conventional
real-time PCR techniques, without the need for standards.
According to QuantaLife, the system is the first cost-effective,
high-resolution platform
available for the validation of next-generation
sequencing discoveries. It is easy to use, easy to automate and easy to
integrate into existing
workflows in both life-science and clinical research
labs."
The QuantLife products joined Bio-Rad's
life-science
research product line. But more than that, Rosen notes, in August 2012, Bio-Rad
Laboratories launched a Digital Biology Center to focus on
the development of
new products based on QuantaLife's droplet partitioning technology, with the
first product based on this technology being the Bio-
Rad QX100 Droplet Digital
PCR.
"In January 2011, RainDance Technologies announced that it,
too, is developing a digital PCR system," Rosen
relates. "RainDance's
microdroplet-based RainStorm technology enables researchers to perform fully
automated biological analysis in disease areas
including cancer, infectious
disease, immunology and genetic screening."
Code: E071312 Back |
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