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Challenges in DNA sample collection for personalized medicine

personalized medicine, DNAWe’ve been hearing the promises of personalized medicine for some time now with its magic formula of ‘the right treatment for the right patient at the right time’. In the past year, we saw the first TV ad for a drug offering genetic testing. Companion diagnostics are now in full force in drug development and there is growing pressure to measure the effectiveness of drugs in the future.

These are exciting times for personalized medicine. At the Personalized Medicine World Conference (PMWC) in Mountain View, CA a few weeks ago, there were 27 companies competing for the PMWC Most Promising Company Award for 2011 – a significant increase over the number competing the previous year. There is no doubt that businesses are joining the personalized medicine revolution at a rapid pace. But there are still significant challenges involved in making personalized medicine real for patients.

Companies planning to launch or improve a current personalized medicine application have to consider how it will be used by doctors, patients, consumers and processing laboratories. A key challenge is finding a way to easily collect sufficient high quality and quantity DNA from patients at home, in the doctor’s office, at the pharmacy or in a medical clinic. Equally important, maximizing lab efficiency and ensuring reliable genetic testing results are paramount to patient well-being.

Traditionally, DNA has been extracted from white blood cells extracted from whole blood samples. White blood cells are an excellent source of large amounts of high quality genomic DNA. However, because of the invasiveness and cost of obtaining, transporting and processing blood samples, blood samples are not always the best option for personalized medicine. Over the past few years, saliva has become recognized as a very important and reliable alternative to blood samples for genetic research, clinical diagnostics and now for personalized medicine. What exactly is it that makes saliva such a good alternative to blood for genetic applications? It all comes down to the source of DNA in saliva.

Saliva is one of the most accessible of our body’s bio-fluids making saliva sample collection easy and non-invasive. Saliva also harbors a wide spectrum of genetic data that can be used for personalized medicine.

Completely non-invasive DNA collection from saliva using a product like Oragene is a simple, painless procedure that requires the patient to spit into a collection device. After providing a sample and closing the lid, a solution is released from the cap to mix with the saliva. This solution stabilizes the DNA for long-term storage at room temperature and prevents bacterial contamination. The high quality and high quantity of DNA collected provides an excellent option for personalized medicine applications whether sample collection is done at home, in the doctor’s office, at the pharmacy or in a clinic.

While collecting high quality and quantity DNA is one challenge, much as been written about other potential obstacles. Recently, The Wall Street Journal’s Hester Plumridge wrote that while personalized medicine offers advantages, it  also could pose significant challenges for pharmaceutical companies. She writes that personalized medicine could narrow each drug’s market potentially resulting in lower sales. Certainly biomarkers could one day be identified that would have a significant impact on a drug’s revenue potential – both positively and negatively. For most pharmaceutical companies, the positive and negative should balance while patients gain access to targeted therapies and treatments that will be more effective.

Personalized medicine should be measured by its value rather than its cost. Its value comes when doctors provide prescriptions for therapy that they know are likely to work. DNA collection with saliva provides companies looking to launch a personalized medicine application with a unique, enabling technology that can scale from hundreds of patients to millions, making it accessible to as many patients as possible. That’s a key step in realizing the full potential of personalized medicine.

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