2018 Report: “Keeping Pace”
“We need to make sure that patients can access accurate, reliable, and clinically meaningful advanced diagnostics as quickly responsible,” said Dr. Scott Gottlieb, FDA Commissioner. “And as we move forward, the input and collaboration of the developer community will be essential.” I was encouraged to hear Dr. Gottlieb looking for ways to speed the market entry of next-generation sequencing tests, especially as our market moves further away from the old “bread-and-butter” routine tests and toward new trends, which are offering labs the opportunity to reinvent themselves. “I know many of you are proud of the work you do to deliver quality, reliable, in vitro diagnostic tests and test services,” he added. “As test developers innovate and the market evolves, we also need to make sure that our regulations are keeping pace.”
Indeed. (His complete prepared remarks can be found here.)
That was just one of the many thought-provoking moments at this year’s American Clinical Laboratory Association (ACLA) 23rd Annual Meeting. U.S. HealthTek is always part of the exchange of ideas and advocacy, which is why we were a Gold Sponsor of this year’s event. The organization advocates for policies that improve the operating environment for laboratories, but the bigger picture is that our collective work results in creating healthier patients. Less important, but something on everyone in this niche industry’s mind, is that a successful ACLA contributes to stronger economic conditions that allow us all to thrive.
Another highlight came from congresswoman Diana DeGette (D-CO), the co-author of the Diagnostic Accuracy and Innovation Act (DAIA). She discussed this “comprehensive reform to create a distinct framework for clinical laboratory diagnostics that advances innovation and protects patients, including for both laboratory developed test services (LDTs) and in Vitro diagnostic (IVD) test kits.” Her view from her Capitol Hill seat was especially valuable.
With the continued, ongoing changes we see in healthcare, we at U.S. HealthTek recognize the importance of the work that ACLA does and want to provide support for their initiatives. On a personal level, I always come away from this annual meeting of the best of our industry with new insights, and new ideas on how we at U.S. HealthTek can serve our clients even better.