• Benign Prostatic Hyperplasia
  • Hormone Therapy
  • Genomic Testing
  • Next-Generation Imaging
  • UTUC
  • OAB and Incontinence
  • Genitourinary Cancers
  • Kidney Cancer
  • Men's Health
  • Pediatrics
  • Female Urology
  • Sexual Dysfunction
  • Kidney Stones
  • Urologic Surgery
  • Bladder Cancer
  • Benign Conditions
  • Prostate Cancer

FDA approves blood test to improve prostate Ca detection

Article

The FDA recently granted pre-market approval to Prostate Health Index (phi), a noninvasive blood test that manufacturer Beckman Coulter, Inc. claims is 2.5 times more specific in detecting prostate cancer than PSA in patients with PSA values in the 4.0 to 10.0 ng/mL range.

The FDA recently granted pre-market approval to Prostate Health Index (phi), a noninvasive blood test that manufacturer Beckman Coulter, Inc. claims is 2.5 times more specific in detecting prostate cancer than PSA in patients with PSA values in the 4.0 to 10.0 ng/mL range.

"Prostate Health Index is a better test because it provides more accurate information physicians and patients need for better decision making," said William Catalona, MD, of Northwestern University, Chicago. "Now, patients and physicians wondering what to do with an elevated PSA test result in the 4.0 to 10.0 ng/mL range have a new, noninvasive option. This represents an advance in the science of prostate cancer management."

The phi test is indicated for use in men with a PSA in the range of 4.0 to 10.0 ng/mL, and helps physicians distinguish prostate cancer from benign conditions. The results of phi’s multicenter clinical study showed a 31% reduction in unnecessary biopsies, according to Beckman Coulter.

The test will be available in the United States in the third quarter of 2012 for use on the company’s Access 2 and UniCel DxI immunoassay systems.

Dr. Catalona is a consultant/adviser, investigator, and meeting participant/lecturer for Beckman Coulter.

Go back to this issue of Urology Times eNews.

Related Content

Janssen submits supplemental applications for prostate cancer therapy

Investigational prostate Ca agent significantly increases survival

Related Videos
Blur image of hospital corridor | Image Credit: © whyframeshot - stock.adobe.com
doctor showing a patient some information on a digital tablet | Image Credit: © bongkarn - stock.adobe.com
A panel of 4 experts on prostate cancer
A panel of experts on prostate cancer
A panel of 4 experts on prostate cancer
Blurred interior of hospital | Image Credit: © jakkapan - stock.adobe.com
A panel of 4 experts on prostate cancer
Related Content
© 2024 MJH Life Sciences

All rights reserved.