Genetic Medicine Finally Hitting Its Stride

The hoopla surrounding the mapping of the human genome 10 years ago is starting to pay off. Although many critics are calling it a big disappointment, citing a paucity of new drugs and treatments, the fact is, they were never very realistic in expecting quick advances. It usually takes about 15 years to get a new drug through development and on the market, and many diseases are proving to be much more complex and challenging. Nevertheless, the map has already become a boon to research, providing a solid foundation for significant breakthroughs in the not-too-distant future.

The next five to 10 years will see huge gains as researchers start to reap real benefits from genetic analysis. Before long, for example, the Food & Drug Administration will approve a promising drug for lupus, Benlysta, from Human Genome Sciences. Amgen’s Prolia, for osteoporosis, got an OK in June.

The advances go way beyond a few drugs. Genetic testing is revolutionizing medicine, offering doctors and patients more-educated choices. With personal gene information, doctors can match patients with the therapies most likely to prove successful.

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Consider the following: Oncotype DX, a test by Genomic Health, can identify whether breast cancer in a specific patient is aggressive and likely to recur. That gives doctors and patients more information to decide whether chemotherapy is a good move. Oncotype DX is also in trials for colon, renal and prostate cancers.

MammaPrint from Agendia predicts recurrence of breast cancer, and in late 2010, ColoPrint will be available to do the same for colon cancer. Sequenom Inc. is developing a test to predict genetic predisposition to age related macular degeneration, a major cause of blindness, for launch in 2011.

Dako is developing a test to determine if patients with metastatic stomach cancer will benefit from Herceptin, a breast cancer drug. The MD Anderson Cancer Center is studying personalized lung cancer therapy by analyzing tumors and a patient’s genetic information to decide which of four possible drugs to prescribe. XDx’s AlloMap is a gene test that identifies patients most likely to reject a heart transplant so doctors can determine immunosuppressive therapy.

Also in development is a gene based blood test to determine if a patient’s cancer has returned. The test would detect the cancer well before a tumor is big enough to be identified by conventional imaging methods. The test, from Johns Hopkins University, looks for bits of DNA in the blood from the tumor.

Gene mapping will also make drug development faster and cheaper. Pairing a new drug with a genetic test that shows which patients will benefit will reduce the time and cost of drug development. It should also make for safer testing, too, since it will identify those patients most likely to suffer from side effects, says Daryl Pritchard of the Biotechnology Industry Organization.

And it will save valuable drugs from the trash heap. For example, Roche’s Herceptin was ineffective in a large trial for breast cancer, but when gene mapping isolated the 20% of patients most likely to benefit, success rates soared, turning a loser into a winner. “If the right patient subset had not been identified, the drug would have failed,” says Randy Scott, CEO of Genomic Health Inc.

All this could mean big savings in health costs as well as better results. Although personal genome maps are expensive, costs will fall dramatically, from about $9,500 today to less than $1,000 in five years, as technology advances. And usually, full mapping isn’t required. Many insurers will now pay for genetic tests, and more are likely to do so as they become convinced there are long-term cost savings to be had.

Plus the savings outweigh the expense. If chemotherapy is ruled out because tests show it won’t make much difference, patients will be spared unnecessary pain, and $15,000-$20,000 will be saved. That scenario could be replicated for scores of other treatments. Plus gene maps show a patient’s susceptibility to some diseases, allowing doctors to suggest preventive measures that can also save lives and dollars.

Bottom line: Significant progress in both health and savings isn’t far away. Treatments will be expensive, but targeting will minimize waste, and costs will fall.