NICE Issues Guidance on Tests for Cancers, Bacterial Infection

The UK’s health care costs regulator is recommending against coverage of two new tests to help diagnose prostate cancer in people who have had a negative or inconclusive prostate biopsy, saying they aren’t an efficient use of government funds.

In final guidance issued last week, the National Institute for Health and Care Excellence said that using Hologic GenProbe’s Progensa PCA3 and Beckman Coulter’s Prostate Health Index to help determine the need for a second biopsy doesn’t lead to improvements in the diagnosis of prostate cancer that are large enough or consistent enough to influence current clinical diagnostic practice.

NICE also recommended against Caliber I.D.’s VivaScope 1500 and 3000 systems for diagnosing potentially malignant skin lesions, saying in draft guidance that while they show promise, there is insufficient evidence to recommend their use in routine clinical practice.

In another draft guidance released last week, NICE recommended five procalcitonin assays — Siemens Healthcare Diagnostics’ Advia Centaur, Thermo Fisher Scientific’s Sensitive Kryptor, DiaSorin’s Liaison BRAHMS PCT, bioMerieux’s Vidas BRAHMS PCT and Roche Diagnostics’ Elecsys BRAHMS PCT — for research use only, pending the outcome of further studies on their effectiveness in clinical practice. The assays measure levels of the biomarker procalcitonin to show whether infections have been caused by bacteria.

Final guidance on the procalcitonin tests and the VivaScope 1500 and 3000 imaging systems is expected in October and November, respectively.

The final guidance on Progensa PCA3 and PHI is available at www.fdanews.com/06-15-NICE-Guidance.pdf.

Comments on the two draft guidances are due June 24. View the drafts at www.fdanews.com/06-15-NICE-Guidance2.pdf and www.fdanews.com/06-15-NICE-Guidance3.pdf. — Jonathon Shacat