Common genetic fusion event may be associated with low-risk prostate cancer -- ScienceDaily

A Gleason score provides information on how aggressive a prostate cancer is. It is calculated when a prostate needle biopsy specimen is examined under a microscope. Depending on how normal or abnormal the cancer looks, it is assigned a number from 1 to 5, with 5 being the most abnormal and most aggressive. Different areas of a tumor may have different patterns, and the two highest patterns are added together to give the Gleason score. Most prostate cancers are Gleason score 6 (composed entirely of pattern 3) and men with Gleason score 6 are considered at low risk of having their tumors progress.

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FDA Proposing to Ease DTC Genetic Tests' Path to Market

The US Food and Drug Administration (FDA) is proposing to ease the approval process for direct-to-consumer genetic tests, saying that the diagnostics can increase consumer engagement in their health.

"In its consideration of [genetic health risk] tests, the FDA seeks to strike a balance that provides for an efficient pathway to bring these tests to consumers, without sacrificing the assurances offered by FDA oversight," said Commissioner Scott Gottlieb, MD, in a statement.

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