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MEDICAL DEVICES PHARMACEUTICALS CHEMICALS FOOD & BEVERAGE ELECTRONICS

THE 2014 MOLECULAR DIAGNOSTICS MARKET DNA Probes and Biochips--New Product Development Opportunities

And Business Expansion Strategies for Instrument and Reagent Suppliers

Sample Pages

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EXECUTIVE SUMMARY TABLE

FRANCEMOLECULAR DIAGNOSTICS TEST VOLUME AND SALES

BY MAJOR APPLICATION2012-2017(millions)

Annual Growth 2012-2017

2012 2017 (%) Application Tests $ (2) Tests $ Tests $

Infectious Diseases (1)

Cancer

Forensic Testing

Genetic Diseases

Paternity Testing/HLA Typing

Others

TOTAL

(1) Excluding blood screening NAT assays.(2) In constant 2011 dollars.

TABLE III-4

FRANCEMAJOR INFECTIOUS DISEASE MOLECULAR DIAGNOSTICS TEST VOLUME

2012-2017(millions of tests) (1)


Test 2012 2017 (%)

AIDS/HIVAdenovirusAnthraxBEA/BartonellaChlamydiaCytomegalovirusEbola VirusEchovirusEncephalitisEnterovirusEpstein-Barr VirusGonorrheaHepatitis HAV HBV HCVHerpes Type VILegionellaLyme DiseasePapilloma Virus (HPV)Parvovirus B19PneumoniaPolyomavirusesSalmonellaShigellaStreptococciTuberculosisWest NileYersiniaOthers

Total

TABLE IV-1

GERMANYLABORATORIES PERFORMING DNA SEQUENCING

BY MARKET SEGMENT2012

PercentMarket Segment Number of Laboratories Of Total

Industrial

Academic

Government

Commercial

Total

TABLE IV-7

GERMANYINFECTIOUS DISEASE BLOOD SCREENIN NAT REAGENT BY ASSAY

2012-2017($ millions) (1)


Assay 2012 2017 (%)

HIV HAV HBV HCV Parvovirus B19 NATWest Nile

Total

TABLE VI-8

JAPANMOLECULAR DIAGNOSTICS MARKET

ESTIMATED SALES AND MARKET SHARES OF MAJOR SUPPLIERS2012

Sales Market ShareSupplier ($ millions) (%)

Total

TABLE IX-2

U.S.A.MOLECULAR DIAGNOTICS MARKET

POTENTIAL LABORATORY UNIVERSE BY MARKET SEGMENT2012

PercentMarket Segment Number of Laboratories Of Total

Hospital

Commercial/Private Laboratories

Physician Offices/ Group Practices

Plasma Fractionation Centers

Blood Banks Community and Regional (*) Military

Public Health Laboratories

Total

(*) Include nine American Red Cross laboratories.

TABLE IX-6

U.S.A.MOLECULAR DIAGNOSTICS MARKET

BY MAJOR APPLICATION2012-2017

($ millions) (*)

Annual Growth2012-2017

Application 2012 2017 (%)

Infectious Diseases

Cancer

Forensic Testing

Genetic Diseases

Paternity Testing/HLA Typing

Others (2)

Total

laboratories. The system uses premade, preassembled glass cassettes that clamp

horizontally into the drawer of the Toaster. Premade cartridges of polyacrylamide

fit into an injector. Using a handle on the injector, the technologist squeezes the

polyacrylamide directly into the cassette. Using UV light, the Toaster polymerizes

the gel in about five minutes.

Visible Genetics’ first application of OpenGene was HIV

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the TruGene HIV-1 Genotyping Kit, sequencer, gel Toaster and computer


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at least semiannually to review HIV resistance data. TruGene purchasers receive


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The Beckman Coulter CEQ 2000 XL DNA Analysis System, is

used for both DNA sequencing, either of genomes or of infectious agents, and for




automated sample preparation systems. Although these product lines are used

mainly for research, there is a potential market in clinical labs. Because of the

modular nature of the CEQ 2000 XL, which makes it possible to add platforms as

itself to automation, which plays an important role, particularly in high volume

laboratories.

d. Chemiluminescence

Chemiluminescence labeling system for DNA probe analysis

offers an exquisite sensitivity, ease of detection, and a quantifiable light system.


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The chemiluminescent substrate systems are available for the





alkaline phosphatase can be accomplished by using a specially modified dioxetane

(AMPPD), available from Tropix and several other firms. The light emitted by

triggered dioxetane is directly proportional to the amount of target substance in




settlement assigned ownership of all patents related to the technology and its use

to Tropix, required Lumigen to compensate Tropix, and prevented Wayne State

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detect 27 strain base differences and identify the presence of mutant bases that

were at a known predetermined level ranging from 10% to 100%. Affymetrix has

been also collaborating with Roche on the development of DNA chips that test for

HIV, p53, and 57 different CF mutations. Although the assay provides an




These DNA chips are the size of a dime but hold thousands of probes that have

oligonucleotide sequences complimentary to the CF gene. The surface of the DNA


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The Affymetrix/Roche collaboration was using multiplex PCR to





corresponded to a DNA sequence. Roche has been developing a prototype

reverse dot blot test that detects 16 common CF mutations with approximately 50

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Beckman Coulter’s DNA chips are similar to Affymetrix and

also use arrays of immobilized oligonucleotides, however, they utilize conventional



distinction of pathogenic and non-pathogenic organisms, and detection of

antibiotic resistance without the need for culture.

During the next ten years, DNA probes for microbiology testing

will not only expand the size of the diagnostics market, but will also supplement

some of the conventional technologies. The probes will increase the amount of



be developed as functional panels for testing sexually-transmitted diseases,

immune status, upper respiratory diseases and other conditions. The future of



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The infectious disease testing is expected to remain the main

focus of DNA probe effort worldwide, at least during the next 5-7 years.

However, many of the microorganisms will continue being identified by traditional




disease testing, some microorganisms, like most Streptococcus, E.coli and

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replace culture methods for them in the near future. Some of these organisms can

be identified as fast in culture as by performing PCR. Another reason culture will

remain a valuable tool for infectious disease testing is the wide range of

extraction system which features primary tube sampling, open system

configuration, the 96-well plate format. Reading is performed on the Prism 7000.

M2000 will process 400 samples in five hours.

Abbott formed a partnership to distribute FISH technology-based tests. The

distribution and marketing deal gives the companies co-exclusive rights to market



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the initial diagnosis of bladder cancer in patients with hematuria suspected

of having bladder cancer. The test is designed to detect genetic changes in

bladder cells in urine specimens using FISH.

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xxxxxxxxxxxx. The joint venture was formed to develop and market DNA

probe-based diagnostic products for the food microbiology and clinical diagnostic

markets. During the first two years of operation, the joint venture invested over

$20 million in the development and commercialization of new products. In




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For clinical use, the company has developed tests for HIV and CMV based

on the target cycling background reduction process using magnetic separation

Coulter acquired assets of People’s Genetics, which gave the company access to

proprietary procedures for both sample preparation and constant denaturant

capillary electrophoresis. In addition to DNA sequencing products, Beckman

Coulter sells reagents for DNA synthesis used as building blocks to create primers



agreements with Orchid BioSciences, to obtain rights to use their SNP-IT SNP

analysis technology on various platforms and to acquire their SNP genotyping



system integrates hardware, software and reagents. The SNPstream products

also include Autoprimer.com, a web-based tool that automatically designs

genotype experiments and associated reagents.

Beckman Coulter has also collaborated with Third Wave Technologies,

Sequenom and Promega to automate front-end sample processing for DNA


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The company acquired Anthos Labtec Instruments GmbH, obtaining

microplate reader detection capability. Beckman introduced for Anthos consortium.

would use Gen-Probe’s NAT technologies to rapidly detect, at the point of sample

collectoin, the presence of harmful microorganisms and genetic mutations. The

platform could be used in physicians’ offices, outpatient clinics, blood screening

centers and various industrial settings.

Gen-Probe has licensed technology from AdnaGen (Hanover,Germany)

that increases the accuracy of molecular diagnostic tests used to detect

prostate and other cancers, determine the aggressiveness of these malignancies,

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accomplished through two steps that combine the benefits of immunoassay and

nucleic acid testing.

The company has licensed rights to develop molecular diagnostic tests

for 50 genetic markers for various cancers from Corixa (Seattle, WA). The markers

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Nanogen and Prodesse signed a collaboration agreement to develop

automated microarray based products to detect infectious diseases, including

Influenza, Pneumonia, Adenovirus, Herpes, West Nile Virus and SARS. The

companies are integrating Prodesse’s mutiplex amplification technology with

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products for genomics and molecular diagnostics fields, including the detection of

inherited diseases, SNPs to identify individuals at risk for disease or adverse drug

reactions, and gene expression measurement. Epoch has developed the MGB


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identification of infectious organisms. Nanogen has begun incorporating Epoch’s

technology into its own assays. Epoch has several product offerings for molecular

research and diagnostic applications, including research reagents and services for

with Veridex, a Johnson & Johnson company which will market preanalytical

solutions under its GeneSearch trademark.

The company launched an extensive product portfolio for integrated genome

wide RNAi and SYBR Green-based RT-PCR.

QIAGEN and Epigenomics (Frankfurt, Germany) entered into a strategic



and market the portfolio of RNAture’s nucleic acid isolation products from Hitachi


giving Beckman Coulter the rights to market two of QIAGEN’s automated sample


platform; obtained an exclusive license from Procognia to market “on -chip”


PCR-based molecular diagnostic products for pathogenenic, genotyping and

pharmacogenomic testing.

QIAGEN extended the distribution agreement with Abbott and received

rights to a number of real-time PCR diagnostic tests developed by artus for use


Abbott received non-exclusive rights to infectious disease tests for HBV, EBV,


a menu of tests developed and manufactured by Abbott and Celera Diagnostics.

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