In Regulated Clinical Sequencing, Choosing the Right Informatics Provider Trumps Everything. Part I

“It is a lot easier to generate the data than [to] interpret it. You have to adequately resource the informatics function for interpretation. If you don’t, you end up with a very expensive paper weight in your department.”

Genetics in Medicine, December 2014

Ace_of_spades.svgMaking a decision on how to resource informatics for your genomics operation is, in many respects, akin to choosing a political candidate. The stakes are high. The process is lengthy. There seems to be a never-ending choice of candidate technologies to choose from. And once a decision is made, like it or not, you have to deal with the repercussions of that decision for a long time. The big difference? In business, your vote is sure to matter.

Though it’s difficult to make the leap from political revolution to genomic revolution, the healthcare industry is in need of dramatic change. Despite all the talk about precision medicine, the genomic revolution, democratization of sequencing and other grandiose headliners, Francis Collins’ bold prediction in 2000 that, “many primary-care providers will begin to practice genetic medicine [by 2010]” was completely off the mark.

The reality is that health systems in general have been reluctant to adopt next-generation sequencing technology. The majority of clinical sequencing is still performed (at least at scale) by only a handful of larger testing labs.

Why?

You can find the answer in a recent Genetics in Medicine article titled, The business of genomic testing: a survey of early adopters,” where the most cited barrier by leading medical directors and pathology department chairs to the deployment of genomic testing was, “scarcity of informatics expertise.”

This revelation is not surprising, nor are the nine additional barriers profiled in the article (repeated below for your convenience.) We at Tute Genomics work resolutely through these issues with our clients on a daily basis.


Barriers to deployment of genomic testing and unanticipated needs (Genetics in Medicine, December 2014)

  • Scarcity of informatics expertise
  • Rapidly changing nature of technologies
  • Validation of clinical testing protocols
  • Expense of implementation
  • Amount of data to curate
  • Difficulty of getting first application deployed
  • Ethics of reporting “all data” as opposed to “clinically indicated data”
  • Lack of institutional resourcing of staff on-the-job training
  • Uncertainty of reimbursement
  • Uncertainty of clinical utility

Fortunately, as the clinical utility of next-generation sequencing is increasingly proven, strategic opportunities abound for commercial diagnostic laboratories and health systems alike to offer new, life-changing tests to their patient populations. However, for there to be true democratization of regulated clinical sequencing, all of these barriers need to be addressed in spades. Given the scarcity of informatics expertise, which in many respects exacerbates the other barriers, the trump card for most diagnostic laboratories and health systems will be choosing the right informatics partner.

With that I ask you, as an early adopter of informatics innovation, will you ultimately choose the “Donald Trump” new-kid-on-the-block enigma that inspires revolutionary visions of success with unfounded track record, or the “Hillary Clinton” know-what-you’re-gonna-get established choice. In my experience, most organizations would prefer a combination of both.

In Part 2 of this series, It’s Not Build vs. Buy. Rather, Whom Do I Partner With? I address the ‘build vs. buy’ dilemma every organization finds itself struggling with. The answer is not what you think. In the meantime, to help you make a more informed decision, I encourage you to learn more about what Tute Genomics has to offer by visiting our website or by watching one of our archived webinars.

Wear that ‘early adopter’ badge with honor. Make our hospitals great again. Your patients are counting on you!

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Josh Forsythe

VP, Marketing at one of most innovative and exciting technology companies in healthcare. Enjoy posting on genome-guided medicine initiatives and pediatric diagnostic cases solved through genomic sequencing.

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