Genomic Health ($GHDX) launched its prostate cancer diagnostic this week with great fanfare, backed by seven studies including over 1,100 patients. The challenge ahead: convincing men that results telling them they can wait for more drastic and expensive treatment options are to be believed.
There is a strong pedigree behind the technology, developed by scientists at the University of California, San Francisco and the Cleveland Clinic. Oncotype Dx measures 17 different genes to predict how aggressive a particular prostate cancer has become. All of that data comes from a prostate needle biopsy sample taken before surgeons take out the prostate, and clinicians compile the results using a Genomic Prostate Score ranging from 0 to 100. That data goes beyond current diagnostic standards, including PSA and biopsy Gleason Score, and is intended to give surgeons a more detailed assessment of how to treat prostate cancer patients.
The company is touting results from its recent UCSF validation study involving 395 patients, showing the test boosted the number of patients identified as very low risk. What's more, the test also helped researchers reclassify about 10% of patients as having a more aggressive form of the disease after they were initially assessed by other means as being low or very low risk. Genomic Health says the results show the test can be more precise, better filtering out patients that need aggressive treatment versus the ones that simply need "watchful waiting" because of a low-risk tumor.
As The Associated Press reports, the hope is that the test will triple the amount of men diagnosed with prostate cancer for whom monitoring, rather than surgery or chemotherapy, is the best option. But some experts, according to the article, question whether the test is enough to persuade men in that category to simply wait and see. The test, as well as others developed by companies such as Myriad Genetics ($MYGN), could greatly advance the standard of care. As The New York Times reported earlier this year, payers may not want to pay for the pricey new diagnostics (most in the $3,000 range) considering that men might still pursue costly treatment even if the test tells them they don't have to.
Genomic will charge $3,820 for its test, according to the article--not cheap by any means. But the company argues that it will save money in the long run by successfully dissuading men from avoiding costly treatment they don't yet need. That may be, but they'll have to be convinced to not pursue more drastic treatment options first. Time will tell.
- read the release
- here's The Associated Press story