DIAGNOSTICS
October
2005
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In Focus
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IN FOCUS
This section gives in nutshell a few news items gleaned from published research material pertaining to diagnostics and diagnostic products. The scientists, researchers and the medical professionals may find the information of interest.
 
   
Cancer Diagnostics
 

Advanced diagnostic systems are an essential tool to characterize and classify specific types of cancer. Accurate testing is a crucial factor in determining the appropriate therapy and prognosis of a patient in the fight against cancer. The US based Clarient Inc., a cancer diagnostics services and technology company, and DakoCytomation of Denmark, one of the world's leading providers of cancer diagnostic tests and automated testing equipment, signed a five-year distribution and development agreement that allows DakoCytomation to distribute Clarient's digital cellular imaging and analysis system (Chromavision Automated Cellular Imaging System) as an adjunct to DakoCytomation's suite of automated diagnostics equipment.

Through this partnership, DakoCytomation's market leading staining systems will be marketed with Clarient's proven image analysis technology to help pathologists and physicians make diagnostic and therapeutic decisions. The agreement also contemplates that the companies will begin developing more advanced integrated cancer diagnostics solutions as also invest in the development of a next generation system.

 
(Clarient Inc News, July 19, 2005)
 
 
Colorectal Cancer Screening
 
Every year, more than 50,000 Americans die from colorectal cancer, the nation's second leading cause of cancer deaths. The US based Biomerica, Inc a global medical technology company, announced the successful conclusion of a 17,897 - participant colorectal screening campaign in Fort Wayne, Indiana, USA. The aim of the campaign was to educate the public about colorectal cancer and to encourage television viewers to pickup a colorectal screening kit at the local Pharmacy.

Biomerica's EZ Detect(TM) Stool Blood Test, which detects hidden blood in the stool (an early warning sign of colorectal cancer) was distributed in the campaign. This is the simplest home test available. The product is sanitary, requiring no stool handling, and has no dietary restrictions. The EZ Detect(TM) pad is dropped into the toilet after a bowel movement, and if blood is present in the stool, the pad will turn a blue-green color within two minutes. Blood in stool may be caused by irritated polyps that have formed in the colon. The blood disperses onto the surface of the toilet water and is detected by the EZ Detect(TM)pad.

Pharmacies in the Fort Wayne area, including Angola and Defiance, in Ohio, distributed nearly 18,000 EZ Detect(TM) kits to customers. Professional Health Care Associates (PHCA) of USA organized and co-ordinated the campaign.

 
(Biomerica Inc News, July 7, 2005)
 
   
Diagnostic Marker for Asbestos Related Cancer
 

Libby in Montana (USA) has one of the highest pleural mesothelioma cancer rates of any community in America. Exciting new developments using a blood serum marker to detect cancer, are being investigated in a longitudinal study in Libby Residents, many of whom have been exposed to asbestos. The residents have agreed to participate in a long term study to caliberate a newly released test for detection of mesothelioma.

Mesothelioma is a malignant tumor that aggressively invades the mesothelial linings of the lungs, abdomen, heart or testicles. Mesothelial cells produce a number of soluble proteins that can be detected in the blood. Elevated levels of a particular protein, called soluble mesothelin related protein (SMRP), appear to be closely tied to the presence of mesothelioma. A test for the presence of SMRP, called Mesomark(TM), had been available in Australia and has become available in Europe in the spring of 2005.

In a project funded by the Mesothelioma Applied Research Foundation (MARF), the Centre for Asbestors Related Disease (CARD) in Libby will be using blood samples from 1000 members of the community in Libby.

The Libby study will help to establish whether SMRP can be reliable marker for mesothelioma across different kinds of asbestos and the absolute marker values will help to improve the predictive value of SMRP as a diagnostic tool in the general population.

 
(Centre for Asbestos Related Diseases News Release, Sep 15, 2005)
 
   
Lab-on-Chip Platform for Bacterial Diagnosis
 

Early detection of systemic bacterial infections is essential for the successful management of antibiotic therapy. The US based ST Microelectronics, a global leader in semiconductor, and Mobidiag of Helsinki, Finland, introduced a new lab-on-chip application for DNA-based detection of sepsis-causing bacteria, using a diagnostic panel from Mobidiag that runs on ST's In-Check Platform.

The In-Check platform hosts a pathogen panel developed by Mobidiag to identify ten sepsis-causing bacterial species as well as methicillin resistant strains of Staphylococcus aureus from positive blood culture samples. The diagnostic panel has been designed to optimise the choice of antibiotic therapy in combination with results from Gram-staining, an empirical comparative method of differentiating bacterial species.

ST's In-Check lab-on-chip platform amplifies clinically relevant DNA samples by Polymerase Chain Reaction (PCR) and has an integrated custom low-density microassay. Microreactors buried in the micro-electro-mechanical-system (MEMS) chip, carry the mixture of sample and reagents, while on-chip heating elements perform the temperature cycling. Silicon's low thermal capacity and the In-Check design features significantly reduce reaction times and costs, compared with standard laboratory equipment. The risk of cross-contamination inherent in conventional analysis methods are minimized, as the PCR and analysis are performed on the chip in an encapsulated, self contained unit.

The lab-on-chip interfaces to the Thermal Control System (TCS) that actuates, monitors and adjusts the parameters of the reaction. The TCS unit comprises five control modules with independent thermal protocols and random access capability. Optical Signal acquisition is performed by a dedicated portable reader and processed by ST's specialised bioinfromatics software, which can be installed on any PC and operates with Mobidiag's clinical reporting user interface. This software package allows users to easily monitor and control the reaction processes, analyse the results and generate reports compliant with MIAME (Minimum Information About a Microassay Experiment) standards for unambiguous interpretation of data from DNA tests.

The unique combination of ST's leading-edge semiconductor and MEMS expertise with Mobidiag's know-how in microbiological diagnostics opens new possibilities for effective detection and treatment of infectious diseases at the point of need. The highly accurate and rapid results from the ST/Mobidiag solution will reduce the risks of antibiotic misuse and help physicians select the right treatment as early as possible.

 
(Microelectornics Inc News, Sept 14, 2005)
 
   
Proprietary Genotyping Platform Upgraded
 
DNAPrint Genomics, Inc, USA, announced an upgrade in the throughput and cost efficiency of its automated Beckman Coulter GenomeLab SNP stream genotyping platform. Beckman Coulter of USA which manufactures laboratory instrument systems for diagnostic tests and biological research, upgraded DNAprint's SNPstream, Ultra High Throughput (UHT) instrument from 12-plex to 48-plex capability, allowing for an approximate four-fold increase in throughput or the rate at which it can read DNA sequences.

The instrument reads DNA sequence from microarray slides (DNA chips) containing about 18,000 nanospots. Since the upgrade in capability does not require commensurate increases in labor, the company expects to enjoy a significant reduction in price per genotype.

DNAPrint is a developer of genomics-based products and services focused on drug development, pharmacogenomic diagnostic tests, forensics technology and consumer genetic tests. The upgrade was part of a planned expansion of DNAPrint's laboratory size, presence and capabilities as the company grows to handle larger numbers of drug and diagnostics development projects.

 
(DNAPrint Genomics Inc News, July 12, 2005)
 
   
Prostate Cancer Awareness Week
 

The US based Beckman Coulter, Inc, teamed with Prostate Cancer Education Council (PCEC) to provide free and low-cost prostate cancer screenings in various US cities, as part of Prostate Cancer Awareness Week, which would run from September 19 through September 24. To support Prostate Cancer Awareness Week, the company donated thousands of its Hybritech (R) PSA and Hybritech-free PSA blood tests to aid in the detection of prostate cancer, as well as blood tests that measure testosterone and total cholesterol. The Hybritech PSA and Hybritech free PSA blood tests were the first of their kind to be approved by the US FDA.

The PCEC is a consortium of leading physicians, health educators, scientists and prostate cancer advocates. In addition to coordinating national Prostate Cancer Awareness Week, the Council participates in research and technology development related to the detection and treatment of prostate cancer.

Over the past 15 years, more than 3 million men have received screenings as part of Prostate Cancer Awareness Week, making it one of the largest and most successful health screening projects in the world. This year, the PCEC provided free screenings to more than 125,000 men and reach millions more through its awareness and educational campaigns.

 
(Beckman Coulter Inc News, Sept 16, 2005)