The DNA storage system newly purchased by the National Institute on Aging will help its researchers learn more from its extensive collection of patient DNA samples. The physical components of GenVault Corp.s Personal Archive system—announced Monday with the institute as its first customer—can keep DNA stable for decades at room temperature, while the software component helps researchers identify and retrieve samples that are relevant for a particular study.
Patients DNA is full of clues. Tests are already available to predict a persons likelihood of developing certain cancers or neurodegenerative diseases or of responding badly to certain drugs. The dream of personalized medicine and pharmacogenetics is to tailor drugs to individuals genetic makeups.
But using genetic clues in this way means correlating countless human samples with patient information—and this requires that relevant DNA samples can be stored, identified and retrieved. Carlsbad, Calif.-based GenVault, a biological sample management company, plans to fill this need.
GenVaults sample-archiving software can be networked via the Internet or within an institution. David Wellis, GenVaults vice president of business development, said many of the entities interested in using GenVault products already have vast collections of human samples and simply want to use them more often and more efficiently.
"Were not going to replace what [information storage] theyve already done," he said. "So, we built the database to be flexible and linkable."
The database has an Oracle Corp. backbone and a Simple Object Access Protocol (SOAP)-XML interface. It can accept data in most formats and is built to meet specifications set by the Clinical Data Interchange Standards Consortium. One of the reasons GenVaults solution appeals to government institutions, Wellis said, is that it allows several agencies to make wider use of sample collections.
The software does not allow storage of so-called "identifiable information" as defined by the Health Insurance and Portability Accountability Act (HIPAA). This includes information such as names, phone numbers and Social Security numbers. Instead, the software stores data about a patients health and demographic information that may be useful in finding genetic susceptibilities.
Though the software has not received an official designation as adhering to the 21CFR11 electronic security and signature requirements for Food and Drug Administration (FDA) submissions, Wellis said such features have been built into the system.
DNA samples can be extracted from cheek swabs or blood in a way that takes up much less space than other types of samples and allows them to be stored at room temperature.
The physical storage system also uses a biobarcode—a short piece of DNA that doesnt have a biological function—that will travel with the DNA sample as it is studied. That way, a researcher can correlate a given sample with patient information even after the sample is removed from its original storage container.
The National Institute on Aging bought a smaller version of the GenVault system that stores 2,000 or fewer microplates. GenVault also offers programs to store tens of thousands of samples, using robotics to retrieve plates. The Centers for Disease Control and Prevention is using such a system to store data for a study correlating diet and health. Samples can be stored in GenVault facilities or on-site.