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strike them as the best use of their limited resource, Gray says. It’s easier to make a case for using samples as part of an application to the FDA for approval of a new diagnostic test, which presumably should have a positive impact on patients.
Bonnie Anderson, the CEO of South San Francisco-based Veracyte, says the scarcity of samples is an issue that every diagnostic entrepreneur needs to think about early in a company’s life. Her company, which works in partnership with Cambridge, MA-based Genzyme, developed a test that looks at how 142 different genes are expressed in thyroid tissue, to help doctors determine when a lump is truly benign and doesn’t need to be surgically removed. Veracyte went after this market because there’s currently a lot of confusion about what to do with ambiguous conventional diagnostic results, and a lot of money wasted on unnecessary thyroid surgeries.
Importantly, Veracyte’s test was designed from the get-go to require very small samples of less than 50 nanograms. By extracting some valuable information from such a small sample, Veracyte only required doctors to make a very small change to their sample-gathering procedure in clinical trials, which left all the rest of the thyroid sample they needed for conventional analysis, Anderson says.
Essentially, getting the maximum amount of information out of the smallest amount of sample is the name of the game. The pressure to do that only grows when you have four or five different companies competing in a diagnostic category, all beating a path to the same few biobanks with the right kind of samples they need, Anderson says.
The good news is that some of the most advanced biological technologies out there today like high-speed/low-cost gene sequencing instruments are capable of answering a lot of questions based on a single run of a tiny amount of sample.
Still, powerful as those instruments are, they won’t reach their potential unless people and institutions to cooperate. Many samples are obtained today in clinical trials that have pretty limited use for the modern tools of biology, because they were given in the context of a researcher that only wanted to ask one specific question, says Rowan Chapman of Mohr Davidow Ventures, a leading investor in personalized medicine companies.
To get more informational bang out of the tissues, patients need to give informed consent for future use of their samples in a wide array of experiments. There are obviously privacy considerations to think about here—nobody wants to be identified to an insurer as possibly having an increased risk of lung cancer that may or may not be real—so the care and handling of samples requires a lot of thought.
But this is a conversation that patients and doctors and innovators and bioethicists all ought to be paying a lot of attention to. Access to biological samples doesn’t need to be, and shouldn’t be, a major barrier to progress in the genomic age.
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