College of American Pathologists
Printable Version

  Put it On The Board


CAP Today




August 2012

News read or heard lately

FDA OKs Beckman Coulter’s Prostate Health Index

Beckman Coulter has received premarket approval from the FDA for its Prostate Health Index, a blood test that is, according to Beckman’s U.S. Prostate Cancer Pivotal Study Report, 2.5 times more specific in detecting prostate cancer than PSA in patients with PSA values in the 4–10 ng/mL range.

The PHI test is indicated for use in men with a PSA in that range. A multicenter clinical study of PHI found a 31 percent reduction in unnecessary biopsies, Beckman says in its study report.

PHI has been available in Europe since 2010. It will be on the market in the U.S. in the third quarter of this year for use on the company’s Access 2 and UniCel DxI immunoassay systems.

“Prostate Health Index is a better test [than PSA] because it provides more accurate information physicians and patients need for better decisionmaking,” William Catalona, MD, PHI researcher and director of the Clinical Prostate Cancer Program at Northwestern University in Chicago and founder of the Urological Research Foundation, said in a statement. “Now, patients and physicians wondering what to do with an elevated PSA test result in the 4–10 ng/mL range have a new, noninvasive option.”

Kevin Slawin, MD, also a PHI researcher and founder of the Vanguard Urologic Institute and the Texas Prostate Center at Memorial Hermann-Texas Medical Center, said in the statement, “Now, with FDA approval in the U.S., PHI can help physicians discriminate between prostate cancer and benign disease while reducing the number of negative prostate biopsies.”

Beckman Coulter offers the commercial automated assay p2PSA for the quantitation of [-2]proPSA, and its PHI combines the results of total PSA, free PSA, and p2PSA.

A Beckman-Coulter-funded study published this month (Nichol MB, et al. BJU Int. 2012 Aug;110[3]:353–362) evaluated, from a U.S. societal perspective, the cost-effectiveness of early detection with PHI in combination with a PSA test compared with a PSA test alone. The strategies of PSA test alone and PSA plus PHI were compared under two PSA thresholds (≥2 ng/mL and ≥4 ng/mL) to recommend a biopsy. The authors concluded that adding PHI to borderline PSA results under both thresholds produced total cost savings and increased effectiveness compared with PSA alone. They say future studies should address the long-term benefits of adding PHI and the relationship between screening strategy and outcomes.

MDxHealth, Merck expand glioblastoma drug-test deal

MDxHealth and Merck KGaA expanded their diagnostics collaboration to include the continued development and commercialization of MDxHealth’s PredictMDx for glioblastoma. It is a test to identify patients who may benefit from Merck’s phase-three cilengitide drug candidate in combination with temozolomide and radiotherapy.

The PredictMDx test assesses the methylation status of the MGMT (methylguanine-DNA methyltransferase) gene promoter as an indicator of whether tumor cells will respond to some chemotherapeutic regimens. As part of the expanded collaboration, Merck will support MDxHealth’s development of and regulatory activities around the PredictMDx test. After regulatory approval, PredictMDx and cilengitide will be launched together.

In 2008 MDxHealth inked a deal providing MGMT gene promoter methylation testing services to -Merck’s clinical trial program for cilengitide. Last year the firms expanded the deal to include the use of the MGMT assay in Merck’s brain cancer drug clinical trials.

PredictMDx has been used to stratify newly diagnosed glioblastoma patients enrolled in cilengitide clinical studies and identify who may benefit from the drug used in combination with temozolomide and radiotherapy.