Affymetrix receives FDA clearance for the first gene-expression microarray-based test

Affrmetrix has received FDA clearance for the first gene-expression microarray-based test, for tissue of origin (identifying the original source organ of metastasizing cancer cells). 

The U.S. Food and Drug Administration has cleared for marketing a test that can help health care professionals determine what type of cancer cells are present in a malignant tumor.

The Pathwork Tissue of Origin test compares the genetic material of a patient’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. The test considers 15 common malignant tumor types, including bladder, breast, and colorectal tumors.

That's cool.  (There is more on the FDA's website.)  And at bottom this is a software test, the first of many...