e. coli diagnostics market: us, europe, japan test volume, sales … disease/sample... ·...

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E. Coli Diagnostics Market: US, Europe, JapanTest Volume, Sales Forecasts and Supplier Shares by Country

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FRANCEE. COLI

TEST VOLUME AND DIAGNOSTICS SALES BY MARKET SEGMENT2011-2016(millions)

Annual Growth 2011-2016

2011 2016 (%) Market Segment Tests $(1) Tests $ Tests $

Hospitals

Commercial/Private Labs

TOTAL

GERMANYE. COLI




Hospitals


TOTAL

ITALYE. COLI




Hospitals

Commercial/Reference Labs

TOTAL

JAPANE. COLI




Hospitals

Commercial/Reference Labs

TOTAL

SPAINE. COLI

TEST VOLUME AND DIAGNOSTICS SALES BY MARKET SEGMENT

2011-2016(millions)

Annual Growth

2011-2016 2011 2016 (%)

Market Segment Tests $(*) Tests $ Tests $

Hospitals


TOTAL

U.K.E. COLI




Hospitals

Public Health


TOTAL

U.S.A.E. COLI


Annual Growth2011-2016

2011 2016 (%)Market Segment Test $(*) Test $ Test $

Hospitals


Physician Offices

Public Health Labs

Total

The diagnosis of xxxxx diarrhea involves testing 10 lactose-positive

colonies (or colony pools) from a primary agar culture for xx and xx. The traditional

method for detecting LT involves testing culture filtrates of colonies on xxxx adrenal or

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the intracellular concentration of cyclic AMP and leads to a reversible "cytotonic"

morphologic response which can be seen by microscopy. CHO cells respond by

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ST is a low-molecular-weight protein which is nonantigenic and not

detectable in cell culture. xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx

recognized. STa traditionally has been detected by using an infant mouse assay.

A variety of immunospecific tests (including ELISA, receptor ELISA, latex,

and coagglutination) have been developed to detect both STa and LT. xxxxxxxxxxxxxxxx

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using synthetic oligonucleotide probes specific for genes encoding the toxins. Echeverria

and colleagues have used replicate blots and DNA hybridization techniques to detect LT-

positive and ST-positive E. coli and also to detect strains expressing other virulence

factors such as xxxx(xxxxxx), invasiveness, and xxxx.

Trimethoprim-sulfamethoxazole and antibiotics in the quinolone group are

commonly used for the treatment of xxxx diarrhea and also as prophylaxis for traveler's

diarrhea.

b. Diagnostic Tests

For detection of diarrheagenic E. coli, stool samples are cultured for routine

enteric pathogens. In the absence of any known potential enteric pathogen, predominant

growth of lactose-fermenting colonies are tested for confirmation as xxxxxxxx. xxxxxxx may

show a Shigella-like biochemical profile. xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx

negative or late-positive E. coli should be check for EHEC. For detection of different

categories of diarrheagenic xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx

wide variety of tests (Table II-8), depending upon the availability of the test in the

laboratory. In most situations, physicians do not feel the need for diagnosis of these

categories of xxxxxxxxxxxx E. coli since E. coli-associated diarrheal illness is of acute onset

and usually self-limiting. Moreover, extensive laboratory testing may not be cost effective.

But the implication of these diagnostic methods has great impact in certain situations like

epidemiology and public health issues, where diagnosis is of prime importance. Following

is a list of DNA Probes for Characterization of Diarrheagenic E. Coli:

Enteropathogenic E. coli (EPEC)

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XII. ALTERNATIVE MARKET PENETRATION STRATEGIES

A. Internal Development

During the next ten years, the infectious disease testing market will be driven

to a large extent by the advances in science and technological innovations. Generally, in a

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technology as a corporate strategic asset, which is managed along with business and

marketing strategies. Integrating the new technology planning into business and corporate

strategies will be the most challenging task facing the current and future suppliers of

infectious disease testing products during the next ten years.

The advances in technology will expand the variety of the current product

offering, including both instruments and reagent systems, which will demand new and

innovative marketing skills. The new products will not only improve the current testing

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but will also contribute to the greater efficiency and cost-effectiveness of the medical

practice. The successful marketing of these innovative products will require

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B. Collaborative Arrangements

Joint ventures, acquisitions, and licensing arrangements are expected to

gain in popularity among infectious disease testing product suppliers as effective

alternative market entry vehicles. Thus, under the joint venture arrangement between a

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and cause adverse drug reactions, is the first CE marked microarray product launched

through Roche--Affymetrix collaboration. Availability of the GCS 3000Dx system offers

Roche Diagnostics and other partners an in-vitro diagnsotics platform to develop

genotyping and gene expression array-based assays. The GCS 3000Dx instrumentation

system comprises a GCS 3000Dx Scanner with AutoloadersDx, a fluidics station

FS450Dx, and GCOSDx software. The Roche AmpliChip CYP450 allows identification of




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Affymetrix is seeking to extend its network of partnerships to create novel array-

based diagnostics in both the clinical an non-clinical markets. With this “Powered by

Affymetrix” program, the company manufactures the microarrays and instruments while the

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From Roche, Affymetrix receives revenues in the form of transfer payments pricing

royalties on sales of diagnostic kits, and milestone after sales targets are reached.

Affymetrix has also established a research and development collaboration with

Molecular Dynamics to develop miniaturized DNA diagnostics based on Affymetrix

VLSIPS sequencing technology. The collaboration also includes the California Institute of



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oligodeoxynucleotide probe. Lumiphos 530 chemiluminescent substrate can be used for

alkaline phosphatase. The combination of the strand displacement amplification method

with the sensitive and rapid (less than 2 hours) detection system results in the specific

detection of few Mycobacterium species based on signal/noise criteria. The company has

developed a range of SDA-based tests, for infectious and other diseases, in both manual

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BD has developed automated systems based on chemiluminescence and second-

generation fluorescence polarization detection technologies. The latter provides full

automation, increased sensitivity, and reduced turnaround time, e.g., 50 molecule

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The ProbeTec in an automated DNA probe system based on SDA technology

capable of processing 48 samples. The test menu includes qualitative assays for

Mycobacterium Tuberculosis, Mycobacterium Genus, chlamydia, gonorrhea and several

other infectious diseases and microorganisms. Assay turnaround time is one hour. An

important advantage of the ProbeTec technology is its rapid analysis time, which can be

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Becton Dickinson's collaboration with Nanogen has been aimed at coding DNA on

a silicon chip and controlling it electronically to perform simultaneous detection and

analysis. The venture has targeted an electronic probe that would be able to reduce the


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and differentiation of rRNA from Chlamydia trachomatis and Neisseria gonorrhea; the

PACE line of non-amplified DNA probe assays; the amplified MTD (Mycobacterium

Tuberculosis Direct); the AccuProbe Group B Strep Test; a range of culture ID assays for

identification of fungal and bacterial pathogens; and several others.

The Tigris is a fully automated DNA probe analyzer, which performs sample

processing, amplification and detection at about 500 tests per eight-hour shift or 1,000

tests per 12-hour shift. The system uses target capture assay technology from primary

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The analyzer uses barcode scanning for positive sample identification and features a

bidrectional interface to the laboratory information system. The system uses transcription

mediated amplification (TMA) to increase rRNA targets a billion-fold in two hours or less,

resulting in an assay sensitivity of less than one cell. The assay format minimizes the

potential for cross-over contamination and does not require thermal cycling. Amplification



removes inhibitors from the samples that impede the amplification process -- high

concentrations of salt, for example. To do this, it isolates the target nucleic acid that is to

be analyzed from a sample, washes the sample, and then returns the target to get it ready



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