From Insights to Innovation: My Experience at the Next Generation Dx Summit
Aug 30, 2024
By Inga Rose, Founder and CEO, Reference Medicine
I was thrilled to attend the Next Generation Dx Summit in Washington DC August 19-21. This annual gathering of 500-plus thought leaders from around the world is an intimate opportunity to share best practices, discuss trends, and talk about what’s on the minds of the people who develop and manufacture diagnostic innovations and technologies.
It had been over 5 years since I attended, so I was very excited to hear about current and emerging topics in the space, meet new people, and see old friends and colleagues.
The meeting did not disappoint.
From enlightening presentations and discussions to manning our exhibition space at the show, we had a great time in DC! And while everyone who attends an industry event will have a slightly different experience and slightly different highlights and takeaways, I wanted to share mine with all of you.
HOT TOPIC: FDA Regulations on LDTs.
The hot topic of the week was the FDA’s new – and much-contested – guidance on the regulation of laboratory developed tests (LDTs) for diagnostics. Topline – LDTs will fall under a much more rigorous and scrutinized process for compliance, with the next four years requiring stages of advancement toward the end goal to regulate LDTs as if they are in vitro medical devices.
This change will have an enormous impact on the processes needed to develop LDTs – from increased documentation requirements for compliance to increased costs to support the new processes.
There’s been pushback from the American Clinical Laboratory Association and the Association for Molecular Pathology, and it remains to be seen what will ultimately happen, but the philosophical dialogue I heard was the question of what to do NOW.
“To prepare, or not to prepare…. that is the question.”
As an operational leader that probably spends too much time thinking about risk and doing everything I can to mitigate it, my take is that knowing how you would prepare, and the things you would need to do, would be a great start. Even this far in advance.
I think it’s inevitable that we will face increased regulatory scrutiny in some shape or form, so my position is: plan now.
More to come on that in a future article - keep an eye out!
Three New-To-Me Companies I’m Excited About:
Learning about emerging technology is always fun and energizing, and I got to meet three new-to-me companies that have some amazing new innovations that have the potential to impact patient diagnostics and care in many new ways.
- Biodesix – This company has two blood-based proteomic tests, the Nodify CDT® & Nodify XL2®, that predict whether a lung nodule is cancerous or not, which has historically needed to be ascertained surgically. This will be a game-changer for the field of cancer early detection and for patients. Also, unlike many other early detection assays that we have learned about from colleagues in the industry, Biodesix’s assay looks at proteins instead of genomic mutations, which is a cool new approach.
- Wren Laboratories – Focusing on mRNA in blood, Wren has both a prostate cancer and neuroendocrine tumor early detection test, with plans to expand to other cancer types such as breast, lung, and colon. The company has been around for 12 years, run by academics that have some amazing AI/ML algorithms on whole blood for the detection of neuroendocrine and prostate tumors, and are now bringing in help to commercialize their superior technology.
- Seek Labs – This company is developing an at-home device for PCR testing: “Moving Molecular Diagnostics to Point of Care.” Personally, I felt like the folks I talked to from Seek were cut from the same cloth as me: science is FUN, and we just want to make an impact. It was like I had known them for years. And just like Reference Medicine with our stickers, they delighted me with some really cute t-shirts.
Favorite Quote of The Meeting:
"I was told that I need to come by for your stickers."
OK, OK – shameless plug – but we heard this more than once from guests at our booth, and it never gets old. We love making our fellow scientists smile!
Next Up
Our next event will be AMP 2024 in Vancouver, Canada from November 19-23 – we’ll be at booth #406 so if you’re planning to attend, come see us there!
