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The following information has been compiled from publicly available sources, StratCom does not assume any responsibility for the accuracy or the authenticity of the information and StratCom cannot be held liable for errors.

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Molecular Biology — March 2004

Cytyc Corporation and DakoCytomation Denmark A/S have entered into a joint agreement focused on the investigation of the biomarker p16INK4a. The companies plan to evaluate the utility of DakoCytomation's CINtec p16INK4a Cytology Kit when used on Cytyc's testing platforms. The CINtec p16INK4a Kits are based on technology licensed from mtm Laboratories AG, Germany. p16INK4a is potential biomarker for screening tests for progression of Atypical Cells of Undetermined Significance (ASC-US). The p16INK4a protein is expressed as a consequence of abnormal E7 gene activity following human papillomavirus (HPV) infection. As such, it may serve as a marker of high-risk HPV effects on the cervical epithelium.

DiagnoCure Inc. has introduced Odyssee, an automated version of its non-invasive bladder cancer test ImmunoCyt/uCyt+. Odyssee is powered by uCyt+ Suite, a dedicated image analysis software and patient management system developed by Samba Technologies SAS, DiagnoCure's wholly owned subsidiary. The system screens, detects, reports, and archives data and images from ImmunoCyt/uCyt+ fluorescent slides.

Epoch Biosciences, Inc. announced that a new panel of assays targeting single nucleotide polymorphisms (SNPs) identified by researchers at the National Cancer Institute as having a high association with certain cancer patient populations are available. These validated real-time PCR assays are based on Epoch's MGB Eclipse Probe Systems.

EraGen Biosciences has entered into a collaboration agreement with Emory University supported by an NIH STTR grant to develop a quantitative genotyping system useful in the early detection of the HIV variants. The goal of the collaboration is to develop a quantitative genotyping system for early response to therapeutic resistance.

Infectio Diagnostic Inc. (IDI) has received FDA clearance to market its ultra-rapid test (IDI-MRSA) for detecting methicillin- resistant Staphylococcus aureus. This is the first MRSA test cleared by the FDA for use directly on clinical specimens.

Jurilab has launched DrugME a microarray-based genotyping test to be primarily used for the identification of genetically-mediated metabolic patterns in clinical trials. This test complies with the FDA "Innovation or Stagnation" initiative that will change methods in current drug development methods. Containing a combination of 27 SNPs from 8 genes, DrugMEt genotypes all the genetic variations proven to play a critical role in the metabolic pathways of most known drugs and is able to distinguish between heterozygous and homozygous individuals.

RoboDesign International, Inc. has entered into an agreement with Isis Pharmaceuticals' Ibis program to design, develop and manufacture commercial ready, self-contained systems for the identification of infectious organisms. The systems are based on Ibis' fully integrated biosensor technology, called TIGER (Triangulation Identification for Genetic Evaluation of Risks), which has been developed in collaboration with San Diego-based Science Applications International Corporation (SAIC). The TIGER biosensor can rapidly and accurately identify a broad-range of infectious organisms, including known, unknown, unculturable or bioengineered elements that could be used in biological warfare attacks. The device may have future commercial potential in the public health arena as a tool to more rapidly and accurately diagnose infectious diseases.

Roche Diagnostics has received FDA clearance to market the COBAS AmpliScreen HIV-1 Test v1.5 for use as a qualitative in vitro test for the direct detection of Human Immunodeficiency Virus Type 1 (HIV-1) in source plasma and organ donors.

Spectral Genomics, Inc. has acquired Bacterial Barcodes, Inc., the company that developed the DiversiLab System based on proprietary rep-PCR technology for bacterial strain identification and infection control. The license supports Spectral Genomics' Constitutional Chip to be introduced in 2004 as well as anticipated specialty arrays to be used in cancer diagnostics.

U.S. Genomics has launched its Trilogy platform for direct detection and quantitation of individual molecules of DNA, RNA and proteins without the need for amplification. The first applications will enable direct measurement of microRNA and siRNA, allowing researchers to screen their samples rapidly against a panel of all known small RNAs as well as perform validation and characterization of specific microRNAs and siRNAs of interest.

Third Wave Technologies Inc. introduced its Invader Cystic Fibrosis (CF) genotyping analyte-specific reagents (ASRs). The product enables laboratories to develop individual assays for each of the 25 CF genetic mutations recommended for screening by the American College of Medical Genetics and the American College of Obstetricians and Gynecologists, plus 19 other important CF mutations.

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