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FDA Clears Test That IDs Types of Tumors

Article-FDA Clears Test That IDs Types of Tumors

Not all breast tumors are the same. Nor are all bladder tumors. Nor are all colorectal tumors. Yet medicine has considered them such for years. Treatments have focused on which organ the tumor resides in, yet we know that no single treatment works for all tumors found in a certain organ. There is now a test that will enable scientists and caregivers to differentiate malignant tumors. FDA has cleared the The Pathwork Tissue of Origin test, which can help determine what type of cancer cells are present in a malignant tumor.

It compares the genetic material of a patientâEUR(TM)s tumor with genetic information on malignant tumor types stored in a database. It uses a microarray technology to analyze thousands of pieces of genetic material at one time. "With the help of microarray technology, [scientists] 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," said CDRH director Daniel Schultz. The test's software converts the scanned image data to gene expression measurements. The gene expression patterns are compared with known gene expression patterns in the database that correspond to different tumor types. And that knowledge can help clinicians determine the best course of treatment. The test is made by Pathwork Diagnostics. It uses a gene expression array made by Affymetrix Inc.

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