Clarient has launched a new gene expression diagnostic for prostate cancer, the Insight Dx Prostate Profile (Insight). The test, developed in conjunction with Health Discovery Corp., uses expression values from four genes to identify the presence of prostate cancer cells.
In its clinical validation study, Insight achieved a sensitivity of 90% for correctly identifying the presence of Grade 3 or higher prostate cancer, and a specificity of 97% for correctly identifying non-cancer tissue (normal and BPH).
There are over 1 million prostate cancer tissue biopsy procedures performed annually in the U.S. Approximately 25% of these tissue biopsies are reported “positive”, indicating the presence of prostate cancer. The other 75% of prostate cancer tissue biopsies are reported as “negative”. Notably, a full one-third of the men with initial prostate cancer tissue biopsies that are reported as “negative” for prostate cancer actually do have prostate cancer that was missed by the biopsy.
Clarient’s new molecular diagnostic could assist physicians in more accurately identifying the presence of prostate cancer in patients with both positive and negative biopsy results. To speed market uptake, Clarient and Health Discovery Corp. have transitioned to a non-exclusive distribution agreement that allows additional laboratories to perform the diagnostic.
Previously: Clarient: Q3 Revenues up 59%; Raises Guidance