BioCurex, Inc. has obtained Canadian approval for the Histo-RECAF diagnostic kit for the detection of cancers of breast, lung, stomach, prostate as well as lymph node tissues. The RECAF cancer marker is also present in all malignant tissues studied to date. BioCurex intends to immediately market the kit to a broad customer base, including medical oncologists, laboratory directors, researchers and other healthcare professionals. The company has also initiated discussions with potential distribution partners in Canada.

Bio-Rad Laboratories, Inc. and Specialty Laboratories, Inc. have entered a deal whereby Specialty will provide testing services using Bio-Rad's new Hereditary Hemochromatosis reagents based on Linked Linear Amplification (LLA) technology.

Caliper Technologies Corp. and Agilent Technologies Inc. have introduced a kit to perform cell analysis assays on the Agilent 2100 Bioanalyzer. The Cell Fluorescence LabChip kit is intended for use by biochemists, molecular biologists, and cell biologists, and is designed to provide benchtop access to perform a range of cell cytometric analyses. The kit performs a range of common cell analyses, including apoptosis analyses, surface and intercellular protein expression determination and viability assays.

Evacyte Corporation has developed Optical Cell Stretcher, a test to determine whether cells in a tumor have the potential to spread, allowing doctors to more confidently recommend the appropriate level of treatment. In addition, by isolating cancer cells that are capable of spreading, or metastasizing, the Optical Cell Stretcher will provide pharmaceutical companies with the raw materials they need to develop drugs and therapies for metastatic cancers. The Optical Cell Stretcher requires a sample from a typical breast biopsy. Cells from the tissue sample are placed between two laser beams and gently stretched. Cancer cells stretch more than normal cells, and cancer cells that are capable of spreading stretch most of all. The Optical Cell Stretcher was invented and patented by University of Texas at Austin biophysicist Dr. Josef Kas and graduate student Jochen Guck. Evacyte has licensed the technology and is developing its commercial applications.

InSite Vision Incorporated has introduced its first commercial product, the ISV-900 test for the early prognosis and diagnosis of glaucoma. ISV-900 is being launched under the brand name OcuGene glaucoma genetic test. The kit consists of a pair of buccal brushes used to obtain a sample of the patient's DNA. The brushes are then sealed in a plastic container provided with the kit and, using shipping materials also included in the kit, are forwarded to an analytical laboratory that will assay for gene mutations. Test results are returned directly to the ophthalmologist, usually within a two week period.

Myriad Genetics, Inc. plans to launch a predictive medicine test for malignant melanoma in November 2001. The test, named MELARIS is based on the detection of inherited mutations in the p16 (CDKN2A) gene. Scientists at Myriad Genetics discovered that the p16 gene is involved in the genesis of many types of cancer, including melanoma, leukemia, lymphoma and cancers of the breast, ovary, bone, brain and bladder.

Nanogen, Inc. is developing a multiplex DNA-based protocol for the detection of two genetic mutations, Factor V Leiden and Factor II 20210 Mutation (Prothrombin), at a single location on Nanogen's NanoChip microarray. Nanogen has now internally validated DNA-based research protocols for Factor II, Factor V and for both these mutations in a multiplex format for use on the NanoChip Molecular Biology Workstation.

Orchid BioSciences, Inc.'s GeneScreen business unit has received certification by the American Society of Histocompatibility and Immunogenetics (ASHI) to conduct commercial human leukocyte antigen (HLA) testing on the LabMAP platform of Luminex Corporation. HLA typing is the first step for patients and potential donors in the matching process for stem cell transplantation.

Pel-Freez Clinical Systems, LLC and Pyrosequencing AB's Molecular Diagnostics Business Unit are collaborating to evaluate and develop methods for typing Human Leukocyte Antigens (HLA) using Pyrosequencing Technology. Pyrosequencing AB formed a Molecular Diagnostics Business Unit earlier this year to establish the company's proprietary technology as a standard platform for clinical genetic analysis.

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