Almost everyone concerned agrees that customized medicine is the medicine of tomorrow. In the future, drugs will be tailored individually to each person's characteristics - their genetics and state of health, lifestyle and the specific symptoms of any disease they contract. But these are still future plans, and at present, the number of drugs prescribed only after genetic testing can be counted on one hand.
Medical diagnostic start-up Pronto Diagnostics Ltd. sees itself as a pioneer in the integration of unique human genetics and drugs. The company is still some way from filling the gap in question, but it takes customization one stage further.
Pronto Diagnostics' area of activity is the impact of unique human genetics on drug metabolization processes. "We specialize in the Cytochrome P450 family of proteins, which evolved inside the human body over the years to break down foreign substances entering the body, mainly food," explains company founder and CEO Dr. Nir Navot. "The genes that encode these proteins underwent evolutionary development, according to the type of diet in the respective region." These proteins also control the metabolization of drugs. In other words, every one of us metabolizes each individual drug in his or her own individual way, as a result of the history of the toxic ingredients added to the diet of our ancestors.
The metabolization of drugs by the body has an effect on the dosage required to achieve efficacy, the level beyond which the dosage could be poisonous, the speed of the response to the drug, and so on. "In one person, the customary dosage might be ineffective because he has a lot of the metabolizing enzymes, while another person, who doesn't metabolize the drug that well, is left with all the side effects and zero efficacy," says Navot.
Today, almost every new drug comes with a description of its pharmacogenetics, meaning the effect that differing human genetics have on a drug's action. However, patients are not usually tested to determine which genetic groups they belong to. "What usually happens is a process of trial and error, until they settle on the right drug and dosage," says Navot. "If a certain person can't metabolize the drug at all, the trial and error process could put him or her at risk of being fatally poisoned. If the drug that works efficiently turns out to be the fifth in the trials, he or she will have suffered from side effects unnecessarily and lost precious time."
A change of direction
Pronto Diagnostics was actually first founded 15 years ago under the name Diagenetics. It built its business plan around customized drugs back then as well, but no doctor or patient had heard of the field, and the only people who had were genetics researchers and a few drug company executives whose natural tendency was to oppose it, since drug companies are built on the sale of a single product to a mass market.
The company therefore decided to focus on pre-natal genetic diagnosis kits. It developed several genetic disease diagnosis kits, and it is now the Israel representative for a number of companies that have developed kits in this field. "We've managed to get by on this," says Navot. But the company didn't expand beyond this and changed hands several times, until it was finally reformed four years ago as Pronto Diagnostics.
The company has developed four drug customization tests so far. The first test customizes the right dosage for each patient of the anti-clotting agent Warfarin. The second test adjusts the dosage of the chemotherapy drug FU5, to prevent the presentation of severe and irreversible side effects. The third product is a test for the gene Cytochrome P450 2D6, which affects the processing of a range of drugs, such as Tamoxifen, a drug used to treat breast cancer and infertility, where the gene makes the rate of metabolism excessively slow, and Codeine, a drug used for pain relief and to treat coughing, where the gene affects the rate at which the drug converts to morphine inside the body. The fourth test evaluates the mutation of two genes that affect the rate at which morphine metabolizes in the body. Pronto Diagnostics is also the Israel representative for companies engaging in similar fields overseas, so the range of tests it offers is much wider.
Pronto Diagnostics does not discover the genes itself, but develops tests only, so it is unable to patent some of its products. "We have patents on the testing methodology, but that only gives us protection from imitation, and not a market monopoly," says Navot. "We will be able to register a patent on an additional product we're developing now."
The product has just begun to enter the market, but has not yet seen any significant sales. Pronto Diagnostics finances its activity through its sales of genetic diagnostic kits. It is currently in the process of establishing itself in Israel and intends to eventually expand to Europe, but for the time being it has no plans to operate in the US, where regulation is far more complicated.
Globes: What is the likelihood that insurance companies will agree to cover drug dosage customization?
Pronto Diagnostics sales and marketing manager Shuki Sela: "A manager at one health fund, who was skeptical at first, told me 'I realized that I can save those incidents where a patient of mine starts bleeding and then sometime later, I get a bill from a hospital."
When will we see the day when we can have just one test that will map out all our responses to all drugs?
Navot: "Technically, you can load all our tests and the ones we market onto one chip. Business-wise, it still doesn't work that way. For the time being, the test will be given as part of the treatment when you receive the drug."
Published by Globes [online], Israel business news - www.globes-online.com - on April 30, 2008
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