Prostate Px – pro

M Levin, MD — Thu, 13 Sep 2012 14:25:43 +0000

Risk assessment can be useful to clinicians because it allows assessment of risk versus benefit of partcular treatments. Risk assessment methods currently used for newly diagnosed prostate cancer patients have disadvantages. THey include: D’Amico risk categories, Partin probability tables, University of California, San Francisco-Cancer of the Prostate Risk Assessment risk score, and Kattan nomograms; all rely heavily on traditional clinical variables (eg, serum prostate-specific antigen level, Gleason score, and clinical stage) to estimate risk of various outcomes. Using nomograms maximizes the predictive ability of each factor, allowing for an individualized characterization of risk compared with risk categories or probability tables.

Another approach relies of characterization and analysis of the cancer tissue obtained from a patient. Clinical data is integrated with an analysis of each patient’s cancer using spatial analysis of tissue histology and examining molecular biomarkers, such as androgen receptor, associated with disease progression. This approach represents a cutting edge of diagnostic science, sometimes termed, “Personalized Medciine”. The concept that one can individualize cancer therpay based on specific tumor characteristics is attractive but needs to be proven before being widely adapted. As of now, there is little evidence to support it and no guidelines or professional bodies recommending it.

Prostate Dx is one such test. It uses its own method of data analysis derived from a large patient cohort to generate a personalized report that is sent to the physician for discussion with the patient. This processand information remains proprietary and not peer-reviewed. This testing has not been cleared (or reviewed) by the U.S. Food and Drug Administration (FDA) becasue the company has indicated that Prostate Px does not require FDA approval. The test is considered a laboratory developed test (LDT) and is performed in Aureon’s Clinical Laboratory Improvement Act (CLIA)-certified, College of American Pathologists (CAP)-accredited, New York State-regulated laboratory.

Studies are ongoing to improve standardization and to determine whether this test can enhance prediction of prostate cancer recurrence and risk compared with current standard methods. Memorial Sloan-Kettering Cancer Center is currently recruiting candidates for a prospective study to determine if there is a small peptide mass protein pattern in blood that can distinguish men with clinically latent prostate cancer from men with more a more advanced disease state.

William T Lowrance, and Peter T Scardino,Predictive Models for Newly Diagnosed Prostate Cancer Patients

Rev Urol. 2009 Summer; 11(3): 117–126.

Donovan, Michael J., PhD, MD, et al., “Systems Pathology: A Paradigm Shift in the Practice of Diagnostic and Predictive Pathology, Cancer, Vol. 115, No. 13, July 1, 2009, pp. 3078–3084.

Eggener, Scott E., MD, et al., “Comparison of Models to Predict Clinical Failure after Radical Prostatectomy, Cancer, Vol. 115, January 15, 2009, pp. 303-310.

HAYES Update Search, “Prostate Px® (Aureon Laboratories Inc.) for Prediction of Recurrence of Prostate Cancer,” Lansdale, PA: HAYES, Inc., January 6, 2012.

ImmuKnow Immune Cell Function Assay – pro

M Levin, MD — Tue, 19 Jun 2012 17:33:21 +0000

In April 2002, the FDA approved the Cylex Immune Cell Function Assay (Cylex Inc., Columbia, MD) for the detection of cell mediated immune response in populations undergoing immunosuppressive therapy for organ transplant. FDA clearance of tests does not include specific indications. The test calculates the concentration of ATP (ng/ml) from a calibration curve and compared to ATP level ranges to characterize the cellular immune function of the sample. A variety of studies since 2009 have reached conflicting and contradictory conclusions regarding the utility of this test in liver, heart and kidney transplantation. Some showed no efficacy and others had promising but inconclusive results and recommend farther study. The American Society of Transplantation (AST) does not mention the use of the Cylex Immune Cell Function assay in its recommendations for the screening, monitoring and reporting of infections complications in the evaluation of recipients of organ transplantation (AST, 2006). Chon and Brennan (2009) commented that there is no consensus on the utility of the Immuknow assay in renal transplant rejection other than in the research setting. Martinu et al (2009) commented that “the data in lung transplantation are scarce and not very promising to date”, and that “the ImmuKnow assay does not seem to have the potential to differentiate between infection and rejection in lung transplant recipients and, until more data becomes available, should not be used clinically in this patient population.”

More recent studies continue to exhibit the same pattern. Torio et al (2011) stated that the Cylex ImmuKnow assay provides a rapid assessment of global immune function in immunocompromised patients by measuring the global immune responses of CD4 T cells from a whole-blood sample. The authors concluded that these findings confirmed that the ImmuKnow assay identified transplant patients at risk for infection. It may provide information to guide immunosuppressive therapy, but the assay did not seem to have the potential to differentiate subjects experiencing rejection.

De Paolis et al (2011) concluded that this preliminary analysis showed a beneficial capacity of this assay to represent the global depression of the immune system. They did not confirm the predictive value of higher IK values for an increased risk of an acute rejection episode.

Huskey et al (2011) retrospectively analyzed 1,330 ImmuKnow assay values in 583 renal transplant recipients at a single center from 2004 to 2009 and correlated these values with episodes of opportunistic infections (OI) and acute rejection (AR) in the subsequent 90 days. The authors concluded that these findings fail to show an association between single time point ImmuKnow assay values and the subsequent development of an adverse event in the subsequent 90 days. The optimal use of the ImmuKnow assay in kidney transplantation has yet to be determined. A number of other studies reached similar conclusions.

This test is not currently recommended by any guidelines and should be considered investigational at this time.

Clinical / Medical References:

Chon WJ, Brennan DC. Investigational methods in the diagnosis of acute renal allograft rejection. UpToDate [online serial]. Waltham, MA: UpToDate; October 2009.
Martinu T, Chen DF, Palmer SM. Acute rejection and humoral sensitization in lung transplant recipients. Proc Am Thorac Soc. 2009;6(1):54-65.
Torío A, Fernández E, Montes-Ares O, et al. Lack of association of immune cell function test with rejection in kidney transplantation. Transplant Proc. 2011;43(6):2168-2170.
De Paolis P, Favarò A, Piola A, et al. “Immuknow” to measurement of cell-mediated immunity in renal transplant recipients undergoing short-term evaluation. Transplant Proc. 2011;43(4):1013-1016.
Huskey J, Gralla J, Wiseman AC. Single time point immune function assay (ImmuKnow) testing does not aid in the prediction of future opportunistic infections or acute rejection. Clin J Am Soc Nephrol. 2011;6(2):423-429.

Read the Layperson version here.

Cancer Treatment Today » Tests

Prostate Px – pro

ImmuKnow Immune Cell Function Assay – pro