The Pathwork Tissue of Origin screen compares the genetic material of a patient's neoplasm with genetic information on malignant tumour types stored in a database.
It uses a microarray technology to analyse thousands of pieces of genetic material at one time. The test considers 15 common malignant tumor types, including bladder, breast, and colorectal tumors.
"The clearance of the Pathwork test is another footstep in the continued integrating of molecular-based medicine into standard practice," said Daniel Schultz, M.D., director of the FDA's Center for Devices and Radiological Health, which oversees medical diagnostics. "In the past, scientists have classified different types of cancers based on the variety meat in which the tumors develop. With the help of microarray technology, they will be able to classify these types of cancers in a standardized non-reader dependent manner based on the patterns of gene activity in the tumor cells."
The Pathwork Tissue of Origin test is the second in vitro diagnostic multivariate indicant assay (IVDMIA) device to be cleared by the FDA. In July 2007, the FDA issued a draft guidance document to address premarket pathways and postmarket requirements for IVDMIAs. IVDMIA tests combine the values of multiple variables to succumb a individual, patient-specific effect.
Nearly every cell of the soundbox contains a full set of chromosomes and very genes just only a fraction of these genes are sour on or expressed in any granted cell. Gene expression occurs when sure molecular data contained inside DNA is transcribed to create molecules known as RNA. These molecules in turn make the proteins that perform most of the critical functions of cells.
Microarray technology can simultaneously measure gene expression levels of large numbers of genes. Small DNA fragments are placed or arrayed on a slide and then RNA, which has been extracted from the tumour tissue and labeled with a fluorescent marker, is spread over this "microarray."
Since RNA binds to its complementary DNA strand, how a good deal binding occurs indicates how active the gene beingness evaluated is. This can be determined by putt the array under a scanning microscope and measurement the loudness of the fluorescent light at each point on the array.
Pathwork's proprietary software converts the scanned image information to factor expression measurements. The gene expression patterns are compared with known gene verbalism patterns in the database that agree to different tumor types.
The Pathwork Tissue of Origin test has been found to provide patterns that confirm existing tissue of origin of the 15 common tumor types using monetary standard clinical and pathological info. This truth of this test is similar to that achieved by good pathologists victimization current standards of recitation.
PathChip, the gene formulation array ill-used in the Pathwork Tissue of Origin test, is custom-designed for Pathwork Diagnostics of Sunnyvale, Calif., by Affymetrix Inc., of Santa Clara, Calif. PathChip is the first custom Affymetrix gene verbalism array to be cleared for diagnostic use.
http://www.fda.gov
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