The approach is very simple. Genomic Health have looked at the genetic structure of samples taken from tumours of patients going back 15(?) years. They know the case histories of the patients, so they are able to make statistical associations between the genetic structure and the progression of the disease. Their first test is for breast cancer.
|An SI Board Since November 2006|
They've developed a screen for twenty six(?) genes. A biopsy is taken from a cancerous tumor and sent to Genomic Health. They screen it against a panel of twenty six(?) genes and produce a score that estimates likelihood of recurrence. This allows the patient and doctor to make informed decisions concerning treatment.
Chemotherapy is currently recommended for more than 90% of women who have breast cancer. 83% of women who have surgery and hormone therapy alone, without chemotherapy, will not have recurrence within ten years. Chemotherapy increases that probability to 87%. For those in the 17% that would have recurrence then, chemotherapy can make a substantial difference. The problem is in deciding who's in which group. Oncotype DX (the name given to the test) helps women get the treatment appropriate for them.
The test costs $3 460, which is a lot less than either a course of chemotherapy, or the cost of treating mestastisized cancer. Medicare is reimbursing as well as Kaiser, Primera, Humana, and Aetna. They still have a way to go. They only have 30% of insurers signed up so far. I think they have only been marketing the test for a year or so.
The FDA is probably going to regulate tests of this sort. Genomic Health has validated their predictions and published the results in the New England Journal of Medicine. They welcome the regulation.
The technique can be extended to other cancers. They are working on prostate, colon, renal, and NSCLC. Together their target market is around half a million a year.
The company has a very strong management team. The CEO, Randy Scott is from Incyte, three senior managers are from Genentech, and another was with Guidant and Applied Biosystems.
More information is available at the company's website, www.genomichealth.com. Any discrepancy between my summary and the website is likely a result of my error.