Immunoassay Test Confirmed as a Biopsy-Screening Tool

An immunoassay's diagnostic performance as a biopsy-screening tool for prostate cancer was statistically similar to that of mass spectrometry.

The immunoassay results demonstrated 91% sensitivity with 25% specificity for prostate cancer detection. This was very similar to a previously conducted mass spectrometry assay, which showed 93% sensitivity and 23% specificity.

Miraculins Inc. (Winnipeg, MB, Canada) announced that it had successfully completed the characterization of the performance of its P2V test in an immunoassay format, for use as a biopsy-screening tool for patients with prostate cancer. The P2V test combines two markers, PSP94 and a fragment of vitronectin.

"The sample set utilized for testing the P2V immunoassay was sourced from Miraculins' internal sample bank and concentrated on 122 men in the critical PSA range of 2.5-10 ng/ml with a normal digital rectal exam (DRE)", said Dr. Stephen Frost, director of research and development for Miraculins. "The samples tested were from both spot collections and 24-hour collections taken during a major clinical study performed by the company. While the 24-hour samples did not show improvement over the spot collection samples in testing for this utility, from a clinical perspective, 24-hour collection may be preferred to reduce variability associated with circadian rhythm. Internal testing by Miraculins confirmed the day to day variation in the PSP94 markers' expression."

Miraculins expanded its study for the test as a tool for determining the aggressiveness of a prostate cancer, using the newly developed immunoassay format. P2V's ability to separate aggressive cancers from healthy benign prostatic hypertrophy (BPH) and non-aggressive cancers, with a sensitivity of 90% and a specificity of 51%, was confirmed after retesting 24-hour collection samples from Miraculins' internal sample bank.

Miraculins develops and commercializes non-invasive diagnostic tests, striving to improve the overall diagnosis and treatment of patients by enhancing the information available to physicians.

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