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August 28, 2013 01:00 AM

Decreasing cost of genomic sequencing requires scrutiny of ethics, report says

Joseph Conn
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    The rapidly declining costs of genomic sequencing may impose new obligations on researchers, according to a recent article on the ethics of genetic research published in the journal of the Hastings Center, a bioethics research institute based in Garrison, N.Y.

    The coming flood of genetic data was on display this week as Boston-based Partners HealthCare began offering to clinicians and patients around the world the services of its Laboratory for Molecular Medicine, where providers can send in a patient's blood sample for whole genome sequencing, analysis and interpretation.

    “This future of patient care is literally unfolding in front of our eyes,” said Matthew Lebo, a geneticist at the lab, in a news release about the new program, which had its first customers earlier this summer.

    The Hastings Center authors address two questions raised by researchers and others as genetic data is generated by lower-cost testing.

    One, the easier question, is, “Do researchers have an obligation to return any results to research participants, and if so, which sorts of results are they obliged to return?” The authors conclude that if the question isn't settled, then at least “a good deal of support” is behind the notion that researchers should at least “share some of the individual results.”

    A stickier second question is, “Which results researchers are obliged to return?”

    “There does seem to be an emerging consensus that researchers should return clinically useful results, even if there is not yet agreement about the definition of clinical utility,” the Hastings authors said.

    The American College of Medical Genetics, they note, recently recommended that clinical labs “should now be required to analyze 57 genes that increase the likelihood of diseases for which there is an intervention, regardless of the specific disease that the clinician intended to investigated when she (or he) ordered the sequence.”

    “Our approaches have to take into account the real costs associated with generating and reporting such information,” the authors said.

    Partners spokesman Rich Copp said the system expects more than 100 patients will avail themselves of the service by the end of the year.

    “We estimate that the total cost is about $9,000,” Copp said. “That's everything from analysis, to interpretation, to reporting back to the (referring) physicians.” Turnaround time from blood sample receipt to final report generation is expected to be about 16 weeks, he said.

    The pace of scientific progress in the field has been startling.

    The XPRIZE competition had offered $10 million for the first team to rapidly and accurately sequence the entire human genome of 100 people at a cost of $10,000 each or less. Officials running the contest, however, canceled it Aug. 23, saying that genome sequencing technology “is plummeting in cost and increasing in speed independent of our competition,” according to a statement by Dr. Peter Diamandis, the X PRIZE Foundation's chairman and CEO. “Today, companies can do this for less than $5,000 per genome, in a few days or less—and are moving quickly towards the goals we set for the prize. For this reason, we have decided to cancel an XPRIZE for the first time ever.”

    Follow Joseph Conn on Twitter: @MHJConn

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