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Fortune Tellers in the Medical Suite
NEW YORK, February 8, 2006 LifeScienceStocks.com – The Food and Drug Administration recently announced approval of a new test to determine the likelihood of relapse for breast cancer patients. The test, called Mammaprint is currently marketed in The Netherlands and several other countries by privately held Amsterdam based Agendia.
The test is emblematic of a new and emerging idea in medical science that has the potential to reshape the way medicine is practiced. It has become increasingly clear that genetics play a large role in a broad range of diseases and that an individuals genetic makeup can influence not only their chances of having a relapse following successful cancer therapy, but also their response to specific drugs. Making use of these insights would enable the rise of “personalized medicine;” medicine customized to treat the patient, rather than disease.
The ability to know with a degree of certainty, what drugs and treatments work best for specific individual patients has the potential to transform medical care in a number of ways, both by improving patient outcomes, and by reducing costs. The Mammaprint test, as an example would benefit not only the breast cancer patients who have the highest risk of relapse and thus would most likely benefit from precautionary chemotherapy, but would also benefit the patients at low risk of relapse who could safely avoid the pain, expense and discomfort of unnecessary additional treatment
To date, the difficulty in implementing this concept has been fourfold: first, identify a disease, or a drug that has a clearly different effect or progression across a population; second, isolate a genetic marker, or markers, that can be used to clearly differentiate the response; third, develop an accurate, reliable, cost effective test for the identified genetic markers; fourth, gain FDA approval.
Agendia’s successful progress through this four step challenge heralds signals the beginning of a broad based use of genetics to type individuals to specific response profiles for treatment, taking some of the "art" out of medicine and replacing it with science. Agendia is not alone here, test makers such as Clinical Data (Nasdaq: CLDA) are developing tests that identify specific genetic markers in individuals to pinpoint effectiveness, resistance and heightened susceptibility or immunity to side effects in the administration of medications. In the future medications may not be prescribed because a doctor "thinks" that they will work, but because genetic markers with clear links to defined drug response will show that they work.
Personalization is not limited to bioengineered or genetic therapies. Whether companies are developing small molecule drugs like ARIAD Pharmaceuticals, (Nasdaq: ARIA) which is developing a small molecule initially targeted against sarcoma but with potentially broad applicability to attack multiple cancer types by regulating cancer cell growth, or a biological therapies company like Cell Genesys (Nasdaq: CEGE) developing immunotherapies and viral based products for pancreatic and prostate cancers as well as certain types of leukemia, the consistent theme is that not all patients will respond equally to all treatments and that many different approaches can yield valuable therapies that can have differential results across patient and cancer sub-groups. In this vein, Genitope (Nasdaq: GTOP) (Nasdaq: GTOP) is developing their MyVax cancer therapy customized to individual patients with specific cancer types.
The future of genetics in medicine is becoming a reality today, as Dr. Bernhard Sixt, Chief Executive Officer at Agendia noted, "The FDA's focus on the emerging field of molecular diagnostics underscores the growing importance of personalized medicine.”