A method and kit for diagnosing Bloom's syndrome are provided relying on specific monoclonal antibodies, such as ATCC HB-9311, which recognize the base excision repair pathway enzyme uracil DNA glycosylase from normal healthy individuals and individuals afflicted with genetic syndromes, but fails to recognize uracil DNA glycosylase from individuals afflicted with Bloom's Syndrome.

Disclosed is a method of producing increased amounts of a protein of interest in a cell by induction. The method includes transfecting a cell with multiple copies of an expression vector, each copy of which includes an expressible gene encoding an enzymatically functional dihydrofolate reductase (DHFR) and an expressible gene encoding a protein of interest. Transfected cells are cultured in the presence of methotrexate (MTX) to produce a plurality of clones. A clone containing plural copy number of the vectors which co-express DHFR and the protein of interest is then selected and cultured. The cultured clone is treated with MTX to enhance the expression of the protein of interest by inducing an increase in transcription without substantially amplifying the genes encoding the protein of interest and DHFR.

Amplification of the HER-2/neu oncogene is related to the status of neoplastic diseases, particularly breast and ovarian adenocarcinomas. The presence of multiple gene copies in tumor cells indicates that the disease is more likely to spread beyond the primary tumor site, and that the disease therefore may require more aggressive treatment than might otherwise be indicated by other diagnostic factors. In particular, the degree of gene amplification appears to provide greater prognostic utility than either the estrogen receptor or the progesterone receptor, and provides utility equal to that of the determination of lymph node status. The information provided by the gene amplification test, however, is not duplicative with the determination of lymph node status and the two tests together provide greatly improved prognostic utility.

The present invention provides a drug delivery device comprising encapsulated cells that contain multiple copies of an expression cassette. The drug delivery device of the present invention is useful to supply an animal, including a human, with a therapeutically desirable molecule, including physiological activities lacking in disease conditions or antagonist against conditions in an animal, especially a human.

Therapeutic methods and microorganisms therefor are provided. The microorganisms are designed to accumulate in immunoprivileged tissues and cells, such as in tumors and other proliferating tissue and in inflamed tissues, compared to other tissues, cells and organs, so that they exhibit relatively low toxicity to host organisms. The microorganisms also are designed or modified to result in leaky cell membranes of cells in which they accumulate, resulting in production of antibodies reactive against proteins and other cellular products and also permitting exploitation of proliferating tissues, particularly tumors, to produce selected proteins and other products. Vaccines containing the microorganisms are provided. Combinations of the microorganisms and anti-cancer agents and uses thereof for treating cancer also are provided.