Your Cancer Risk Guide

FDA Approves New Genetic Test for Cancer

A test that helps identify the type of cancer cells present in a tumor has been approved by the U.S. Food and Drug Administration. Federal regulators said today they have given Pathwork Diagnostics of Sunnyvale permission to begin selling a new genetic test to determine what type of cancer cells are in a malignant tumor.

The Pathwork Tissue of Origin test compares the genetic material of a patient’s tumor with genetic data stored in a database from evaluated cancers. The genetic cancer test, which is able to analyze thousands of pieces of genetic material at a time, considers 15 common cancer types, including those of the bladder cancer, breast cancer, and colon cancer.

“The clearance of the Pathwork test is another step in the continued integration of molecular-based medicine into standard practice,” Dr. Daniel Schultz, director of the FDA’s Center for Devices and Radiological Health, said in an agency news release.

The test and its technology are produced by Pathwork Diagnostics of Sunnyvale, Calif., and Affymetrix Inc., of Santa Clara, Calif.

“In the past, scientists have classified different types of cancers based on the organs in which the tumors develop,” Daniel Schultz, director of the FDA’s Center for Devices and Radiological Health, said in the statement.

With the Pathwork test, they now also can classify the cancers “based on the patterns of gene activity in the tumor cells,” he wrote.

“Knowing the primary tumor site with greater certainty enables more appropriate cancer treatment,” said Deborah Neff, chief executive officer for Pathwork Diagnostics.

The test incorporates genetic-identification technology developed by Affymetrix of Santa Clara.

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Cancer Death Rate Falling for Some Groups in the US

“The recent reductions in death rates from major cancers in the US have bypassed less educated working people, suggesting that persons in lower socioeconomic groups have not yet benefited equivalently from recent advances in prevention, early detection, and treatment of the major fatal cancers,” Dr. Ahmedin Jemal, from the American Cancer Society in Atlanta, and colleagues conclude.

Using data from the National Center for Health Statistics and from the US Bureau of Census Current Population Survey, the researchers found that death rates from cancers of the lung, breast, prostate, and colon/rectum generally fell significantly in every race and sex stratum in people with 16 or more years of education.

For instance, in subjects with this level of educational attainment, colorectal cancer mortality fell by 2.4% to 4.8% annually from 1993 to 2001.

The one exception, however, was lung cancer in black women for whom death rates held steady during the study period.

With less than 12 years of education, by contrast, cancer death rates generally remained stable or even increased, as was seen with lung cancer in white women and colon cancer in black men. However, in white women with breast cancer, mortality fell by 1.4% annually.

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