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QIAGEN’s GeneReader NGS provides sample preparation, sequencing and data analysis, which simplifi es the use of sequencing in clinical research. (Image courtesy of QIAGEN.)
Dealing with more data “As sequencing costs have gone down, data
challenges have become more severe,” says Asimenos. “Data that once came into a lab as a trickle has turned into a fl ood.” He adds, “A major challenge in realizing the true potential of clinical sequencing is managing, securing and ascertaining results from these large stockpiles of genomic datasets.
“Once the results have been acquired from ge- nomic analysis, then researchers need to make biological sense of all the genomic variation in the context of disease.” Doing that requires sequencing and analyzing thousands, maybe millions, of patients to reach the needed statis- tical correlation and validation.
To handle these challenges, DNAnexus cre- ated a cloud-based solution, described by Asimenos as a “genome informatics and data-management platform that is used by organizations that are pursuing genomic approaches to health, in the clinic and in the re- search lab.” He adds, “Cloud computing not only mitigates the data deluge issue; it also fosters collaboration across geographic, academic and commercial boundaries.”
This platform is already in use by genome centers like the Baylor College of Medicine (Houston, Texas), and diagnostic-test providers, including Natera (San Carlos, Calif.) and CareDx (Brisbane, Calif.). Users also include clinical and
research sequencing service providers, such as the Garvan Institute of Medical Research (Darlinghurst, Australia).
Reimbursement obstacle In the past, the technology for clinical se-
quencing created the bottleneck. Today, it’s knowledge and payment. “It’s possible for any licensed clinician to order any of these tests,” Chung explains. “The barrier at this point is that some clinicians still don’t know the utility of this testing, so they don’t all feel comfortable or- dering it.” Clinicians who do order sequencing tests face a diff erent obstacle: getting reim- bursed from insurance companies. As Chung says, “Insurance companies are struggling to understand the clinical utility and for which indications there is clinical utility.”
Luckily, the reimbursement part is changing. On January 11, 2016, Independence Blue Cross and NantHealth announced coverage for whole genome and proteome screening. Others will likely follow suit over time.
“The real promise of clinical sequencing is that it is becoming very easy to get to the diagnosis quickly and cost-eff ectively,” says Chung, “and that gets patients to the best treatments.”
Mike May is a freelance writer and editor living in Ohio. He can be reached at mikemay1959@
gmail.com.
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