FDA APPROVES URINE TEST FOR REPEAT PROSTATE BIOPSIES The US Food and Drug Administration
Bibliographic record
Abstract
(FDA) has approved a urine-based mo-lecular assay (Progensa, Gen-Probe) that helps determine the need for repeat prostate biopsies in men who have had a previous negative biopsy. The test, which is already approved and marketed in Europe and Canada, detects levels of prostate cancer gene 3 (PCA3), which is overexpressed in “virtually all prostate carcinoma specimens, ” accord-ing to an independent review published last year (Nat Rev Urol 8:123-124, 2011). The PCA3 assay is indicated for helping to decide whether men 50 years or older who have had 1 or more previous nega-tive prostate biopsy, and “for whom a repeat biopsy would be recommended by a urologist based on the current stan-dard of care, ” should undergo a repeat biopsy, according to the company. Such men have been described as hav-ing a “PSA dilemma ” – that is, an ele-vated PSA score but negative biopsies. FDA approval of the PCA3 assay was based on a clinical study that enrolled 495 eligible men at 14 clinical sites. In the study, the PCA3 assay had a nega-tive predictive value of 90%, meaning that a negative result predicted a nega-tive prostate biopsy 90 % of the time, according to the company. (Continued on page 8)
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.005 | 0.017 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.002 | 0.001 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.005 | 0.002 |
| Insufficient payload (model declined to judge) | 0.065 | 0.040 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".