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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 — Summer 2005

Dear Reader, The summer flew by and what a summer it has been !!! As promised here are this summer's news highlights. Our monthly revisions begin in September. Happy Reading and Best Regards, Shara Rosen

Abbott Laboratories and Celera Diagnostics were awarded the CE Mark for a real-time PCR test for HCV in serum and plasma. The test is designed to assess HCV viral load on the Abbott m2000 system, an automated instrument using real-time PCR technology.

Avitar, Inc. was awarded a patent for an oral fluid collection device used for DNA PCR-based tests. The invention includes the use of Avitar's proprietary hydrophilic foam and provides a simple and inexpensive method for collecting and delivering an oral fluid sample. In addition, the device covered by the patent is used for delivering the sample to a collection matrix, drying the sample on the collection matrix and subsequently isolating DNA from the sample for PCR-based testing.

Beckman Coulter, Inc. began shipping its new Vidiera NsD nucleic sample detection platform, the first in a family of solutions designed for molecular pathology laboratories. The new platform separates DNA fragments of varying lengths for further identification or pattern recognition based on Beckman Coulter's advanced capillary electrophoresis technology.

CeMines is developing the CellCorrect LAb detection kit that will aid in the diagnosis of lung cancer. The test detects altered autoimmunity and associated molecular fingerprints of disease-related autoantibodies in the blood.

Cepheid launched its Customer Specified Reagents (CSR) program that provices access to Cepheid's proprietary SmartBead technology whereby their customer-developed reagents are processed at Cepheid. SmartBeads have already been used in tests for Leishmaniasis, Avian Influenza, Exotic New Castle's Viral disease, bacteria and yeast associated with wine spoilage, E. coli STEC/O157:H7, Vibrio parahaemolyticus, Asian Soy Bean Rust, Enterococcus, and pharmacogenomically relevant SNPs."

Chronix Biomedical is developing a product line for chronic illnesses is based on detecting Circulating Nucleic Acids (CNA) in blood. The first product to be released will be for BSE with tests for prostate cancer, breast cancer, multiple myleoma, multiple sclerosis, and chronic fatigue syndrome to follow.

Ciphergen Biosystems, Inc. and Quest Diagnostics Incorporated formed a strategic alliance to develop and commercialize proteomic diagnostic tests based on Ciphergen's proprietary SELDI ProteinChip technology. Quest purchased 6.2 million shares of Ciphergen common stock, or approximately 17% of shares outstanding, and a five-year warrant to purchase an additional 2.2 million shares for $3.50 per share.

Gen-Probe and Cytyc Corp. received FDA clearance to market an application that uses Gen-Probe's APTIMA Combo 2 assay for chlamydia and gonorrhea on liquid pap smear specimens collected and processed with Cytyc's ThinPrep System. The APTIMA Combo 2 assay is also cleared to detect chlamydia infections and gonorrhea from other sample types including clinician-collected endocervical, vaginal and urethral swab specimens, patient-collected vaginal swab specimens, and female and male urine specimens.

Roche Diagnostics received the CE Mark for the Linear Array HPV Genotyping Test, that identifies 37 high- and low-risk Human Papillomavirus (HPV) genotypes, including those considered a significant risk factor for progression to cervical cancer.

Roche Diagnostics expects to introduce the SeptiFast for sepsis in 2006. The test, which would be priced at about $100 uses PCR to detect and identify bloodstream infections.

Virco BVBA introduced the vircoTYPE HIV-1 resistance analysis that provides "a report card" that includes a grade point average with comprehensive teacher notes instead of a pass/fail grade. The analysis integrates genotypic and phenotypic findings along with expert clinical knowledge - all in one cohesive, easy-to-interpret report.

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* Molecular Biology - May 2005
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