THE "NEW" PROSTATE CANCER INFOLINK

The FierceBiomarkers e-newsletter has compiled a brief report with the above title that may be of interest to some of our readers.

The report, which is available on line, provides some background about the following prostate cancer tests that are in development:

• A prostate biopsy-based genomic assay from Genomic Health designed to differentiate between aggressive and indolent forms of prostate cancer and guide decisions about immediate treatment or less invasive types of management (e.g., active surveillance). One or more clinical validation studies will be initiated in 2012 (probably in conjunction with the Cleveland Clinic). The company hopes to make this test commercially available in 2013.

• A series of protein biomarkers from Oxford Gene Technology that appear to be able to distinguish prostate cancer from control samples with more than 90 percent sensitivity and specificity (compared to 86 percent sensitivity and 33 percent specificity for PSA testing). Any diagnostic test based on this technology is still a long way from the clinic.

• A form of PSA test from Quanterix that is about 1,700 times more sensitive than traditional PSA tests — but how valuable would such a test really be in clinical practice? Would it actually provide information that changes the way doctors treat men known to have prostate cancer and who exhibit a rising PSA after first-line therapy for the better? That’s a really big and important question. Quanterix is hoping they can make this test commercially available some time in 2014.

• Metamark Genetics, working with researchers from the Dana-Farber Cancer Institute, also thinks it can develop a test that will discriminate between indolent and aggressive forms of prostate cancer based on a genetic signature from biopsy specimens. The company has said they think they can make such a test commercially available by 2012, and that may be true, but it wouldn’t have met FDA criteria for commercial marketing by then, so coverage and reimbursement for use of the test may be problematic.

• Myriad Genetics first made its 46 gene-based Prolaris test commercially available in April 2010, but the company is still trying to develop the clinical proof necessary to convince clinicians and insurers (and The “New” Prostate Cancer InfoLink) of the actual value of this test. The test holds a theoretical potential to be able to differentiate between men who need immediate treatment and others who can be monitored with active surveillance and also to predict whether prostate cancer will recur after first-line surgery.

The “New” Prostate Cancer InfoLink has previously commented on four of these five tests that are all still under development. Each of these tests is challenged by the need to clearly demonstrate that it can provide information that is more clinically useful than tests we already have available. None of them will be able to do this convincingly without data from relatively large, randomized, prospective clinical trials.

Filed under: Diagnosis, Living with Prostate Cancer, Management, Risk Tagged: | Diagnosis, prognosis, test