Big Data, Informatics and Specimen Reliability Dominate Discussion at G2 Lab Revolution Event

Opportunities and challenges for laboratories was the key theme of G2 Intelligence’s Lab Revolution and a one-day pre-conference workshop held at the Sheraton Wild Horse Pass Resort and Spa in Chandler, Ariz., April 6-8. The main conference explored innovative business models, market drivers, and practical solutions while the pre-conference workshop, focused on informatics, big data and the opportunities that data provides for laboratories.

Rise of Informatics
The Rise of Informatics and the Lab Workforce of the Future, co-hosted April 6 by G2 Intelligence and academic partner, Arizona State University’s International School of Biomedical Diagnostics, addressed the need for standards concerning data, and how laboratories can profit from big data, establish informatics programs, and acquire the right talent to lead informatics initiatives.

Keynote speaker Dr. Anna Barker discussed data quality and integrity and noted the impact that a lack of reproducibility of research has on molecular diagnostics development.

Irreproducibility of published papers and quality of specimens were the centerpiece of a presentation by Dr. Carolyn Compton who asserted “for the biomedical business flipping a coin is … superior to reading Science or Nature in making business decisions.” She explained the various pre-acquisition and post-acquisition factors that can affect specimen quality and the ability to identify biomarkers. Citing a dearth of standards concerning patient samples, she indicated, “the bar for specimen quality is going nowhere but up.”

As Compton noted, the White House has agreed and issued in 2014 a Request for Information seeking public comment on how the federal government, a significant funding source for research, can help address this problem. Additionally, the National Institutes of Health held a workshop in June 2014 with the Nature Publishing Group and Science addressing principles to improve reproducibility and rigor of research. Compton noted those principles included a stipulation that “[s]ufficient information about sample collection must be provided to distinguish between independent biological data points and technical replicates.”

Compton and Barker both are working toward a solution to this problem through their efforts with the National Biomarker Development Alliance (NBDA). Dr. Barker is the President and Director, and Dr. Compton serves as Chief Medical Officer, for the NBDA, which is seeking an end-to-end, standards-based approach to biomarker development.

Revolutionary opportunities and challenges
The vast opportunities big data presents for laboratories continued to be discussed after the workshop throughout G2 Intelligence’s Lab Revolution conference, April 7-8. An opening keynote address by laboratory industry veteran R. Keith Laughman emphasized that diagnostics are the “most actionable data in health care.” Like Compton and Barker, he noted the need for reliable specimen integrity and advised that the industry needs to consider how diagnostic data generated from lab specimens can be used to improve health care delivery.

Among the challenges labs face, a panel highlighted the FDA’s proposed oversight of laboratory developed tests. Michael Murphy, president of Conatus Consulting, and Richard S. Robinson MT (ASCP) from the American Red Cross Biomedical Headquarters Regulatory Affairs reviewed the current status of the FDA proposal and provided some practical advice to help labs prepare for anticipated new oversight. Murphy emphasized the importance of developing quality systems and noted that in the 20 cases the FDA mentioned in their recent reported concerning problematic LDTs, errors were due to “extremely deficient” quality control. In the short term, he recommended labs focus on quality systems, design controls and document controls. To establish a quality system he set forth three steps: 1) conduct a gap analysis, 2) get management buy in, 3) develop SOPs, and 4) train employees.

.Panelists David W. Gee and Caitlin Forsyth, health care lawyers with Davis Wright Tremaine LLP in Seattle, invoked the Back to the Future theme to advocate that labs learn from the compliance problems of the past to prevent issues in the future. In particular, Gee and Forsyth recommend labs look closely at provisions of the corporate integrity agreements (CIA) involving labs, such as the recent CIA in the Millennium Health settlement. They also highlighted provisions of the OIG’s original compliance guidance as well the recent Millennium CIA that address best practices with regard to requisition form design, medical necessity issues, and Anti-kickback Statute and Stark Law violations involving free items to ordering providers, relationships and agreements with ordering providers, and control of sales materials and operation of sale representatives. Returning to the topic of big data that permeated the conference, Gee and Forsyth highlighted how the government is using big data and real time analytics to spot fraud and compliance issues earlier. The five takeaways Gee and Forsyth summed up with advised labs to 1) get medical necessity documentation right from the start, 2) do real time audits of test requisitions to confirm tests are properly ordered, performed and billed, 3) be cautious of custom profiles, 4) avoid third party marketing, and 5) train and monitor employed sales representatives.

Finally, the final presentations wrapping up the conference addressed future challenges for laboratories including not just management of data but changing technology, and a changing marketplace. George Poste, chief scientist, Complex Adaptive Systems Initiative and professor at Arizona State University and Chris Wasden, executive director and professor of innovation, Sorenson Center for Discovery and Innovation at the University of Utah and Dr. Robert Boorstein all highlighted the emergence of mobile and point of care diagnostic technology, including remote monitoring, wearables and even ingestable technology.