Close

IRIS Int'l (IRIS) Updates on NADiA ProsVue Prostate Cancer Test

May 23, 2011 7:13 AM EDT
IRIS International, Inc. (Nasdaq: IRIS), updates on results from a multi-center clinical study utilizing its proprietary NADiA ProsVue prognostic prostate cancer test in 304 post-radical prostatectomy patients. The Company also announced the submission of an accelerated sample stability study requested by the FDA as part of IRIS's reply to an "Additional Information" letter received from the FDA in March 2011.

From the release:

"The study evaluated 304 patients treated at four clinical sites and followed for up to 17.6 years for clinical recurrence post-radical prostatectomy. Candidates were required to have an initial prostate specific antigen (PSA) level below 0.1 ng/mL (100 picogram per milliliter), which is below the current limit of detection of most FDA cleared assays. Results of IRIS's proprietary ultra-sensitive NADiA ProsVue test were compared with the outcome of documented clinical recurrence following radical prostatectomy. The ProsVue test was able to quantify PSA levels in all patient samples. The clinical study demonstrated that patients with a ProsVue linear slope of less than or equal to 2.0 pg/mL per month within the first year following radical prostatectomy are at greatly reduced risk of prostate cancer recurrence and was highly associated with no evidence of disease in up to 17.6 years of follow-up.

The linear rate of change (slope) of ProsVue PSA in picogram per milliliter (pg/mL) per month post-radical prostatectomy was calculated for each patient using three successive PSA values determined from banked serum samples. A pre-specified cut point of 2.0 pg/mL per month was used to divide patients into two groups as "at reduced risk for recurrence" or "not at reduced risk for recurrence." This binary expression of the variable was compared to the reference clinical categorization of each patient as either exhibiting stable disease or clinical recurrence. The NADiA ProsVue test was compared with traditional risk factors (pre-surgery PSA level, pathologic stage and Gleason score) using univariate and multivariate Cox proportional hazards regression and Kaplan-Meier analysis.

In univariate analysis a ProsVue slope greater than 2.0 pg/mL/month showed a hazard ratio of 18.3, which represents a 94.5% reduction in risk of recurrence for patients with a slope of less than or equal to 2.0 pg/mL per month. In the presence of the traditional risk factors, multivariate analysis showed a hazard ratio for ProsVue slope of 9.8, representing an 89.8% reduction in risk of recurrence for patients with ProsVue slope below the cut point of 2.0 pg/mL per month. Of the traditional factors, only the pathologic Gleason score was a significant predictor with a hazard ratio of 5.4, or an 81.4% reduction in risk for patients with a Gleason score of less than or equal to 6."


Serious News for Serious Traders! Try StreetInsider.com Premium Free!

You May Also Be Interested In





Related Categories

Corporate News, FDA