Is this for real?? FDA Grants Breakthrough Status to TriNetra-Prostate Blood Test to Detect Early-Stage Prostate Cancer

[addicted2cycling]

Can't recall reading about this test but if it is as claimed, why isn't it SOP for the SOC protocol?

onclive.com/view/fda-grants...

[treedown]

Maybe because Drs are slow to add new technology to their process? Does breakthrough status have limitations?

[mperloe]

It's not clear from the press release how they are defining cancer. They quote 99-100% sensitivity. They say it does not detect cancer grade or predict Gleason score. If It detects GL3+3, then it usefulness may be limited.

Every week we hear of new promising tests. It's nearly impossible for us as well as our physicians to know which test is best as side to side comparisons within a single study are rarely done.

[Gl448]

Breakthrough device doesn’t mean it’s approved for use yet, it means the FDA sees the potential benefits as being great enough to give expedited review and assistance during the market authorization request for the product.

The company has received the same breakthrough device status for its breast cancer and brain tumor blood tests, but there’s no mention of them trying to get approval to market any of them in the US yet.

Can’t be SOP for SOC if it’s not approved yet.