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Targeted Molecular Diagnostics -TMD- Announces a Gene Sequencing Service for Mutation Detection in Retrospective or Current Studies

Posted on: Tuesday, 26 October 2004, 12:00 CDT

Targeted Molecular Diagnostics (TMD), an advanced, oncology focused, specialty laboratory that specializes in the application of molecular pathology, today introduced an additional service of gene sequencing in either paraffin-embedded blocks or frozen tissue samples.

"We are delighted to offer our sequencing capabilities on routinely processed material to pharmaceutical companies and to the oncology community," states Dr. Sarah Bacus, founder, president and Chief Executive Officer of TMD. "This additional service will further enhance our ability to assist our pharmaceutical and oncology clients in targeted drug development and in treatment. We are very proud to provide this valuable service knowing that it could directly influence the success of patient therapy."

Mutations in genes that are drug targets may be critical in determining whether a patient will respond to a particular targeted therapy. It is crucial to establish a correlation, if it exists, between gene mutation and responsiveness to therapy as early as possible in patient trials. A genotype-directed clinical trial could increase the number of responders for a particular targeted therapy.

Scientists at TMD have recently successfully validated the sequencing of mutations within two exons in the kinase domain of the human epidermal growth factor receptor (EGFR) gene. Substitution and deletion mutations within these exons have previously been shown to correlate with responsiveness of non-small cell lung cancer (NSCLC) patients to treatment with gefitinib (Iressa(R)), an EGFR kinase inhibitor. Other gene mutations, such as hereditary breast cancer susceptibility genes BRCA1 and BRCA2, or frequently mutated oncogenes such as Ras, can be analyzed in a similar manner.

TMD will prepare DNA from either frozen or paraffin-embedded tissue, design PCR primers specific for the exons (or other regions) of the gene of interest, amplify the DNA in a series of nested PCR reactions and sequence the 2nd round PCR products bidirectionally to identify any mutations present, using a capillary based, ABI Prism(R) 3100-Avant Genetic Analyzer. Any mutations will be verified by sequencing normal tissue from the same patient. All of this can be done from the same samples that TMD receives for immunohistochemistry tests, thus obviating the need to send samples to multiple laboratories for analysis. Since TMD can use either paraffin embedded blocks or frozen tissue samples, sequencing can be done retrospectively on archived material or on current studies.

About Targeted Molecular Diagnostics, LLC

TMD is a privately held, advanced, highly innovative, oncology focused, specialty diagnostic laboratory. The company innovates the drug development process - from pre-clinical through Phase III - by providing guidance through biomarker expression analysis. TMD's scientists have unique understanding in cell signaling and in drug mechanisms of action which allow them to define subpopulations of tumors that will respond to targeted cancer therapies. Doing so enables the drug developer to increase the response rates of their therapeutic asset, greatly reduce the cost of clinical trials and minimize the time for regulatory approval. Additionally, by providing targeted diagnostic testing services to clinical laboratories, TMD catalyzes the adoption of innovative technologies. For more information please visit us at: www.tmdlab.com

Source: Business Wire

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