I cracked open a beer in preparation for the FDA’s (creatively named): “Public Workshop – Standards Based Approach to Analytical Performance Evaluation of Next Generation Sequencing In Vitro Diagnostic Tests”. Oh great, I expected bordem, little did I know I was in for a treat!
The Precision Medicine Movement
Coined (?) by the charismatic Barack Obama (see a great infographic on it), the success of precision medicine ultimately aims to develop (and I quote!) “a new era of medicine through research and technology that empowers patients, researchers, and providers to work together towards development of individualized treatments.”
Which is great, in theory. But, where are we now?And how will we get there? I covered in a few previous posts, the potential of precision medicine in lung cancer, breast cancer and
meat colorectal cancer which may be good for background reading on the topic. However, I still believe (and going off the FDA meeting, so do they?) we are quite a way off from achieving this great set goal.
Cakes are the new tool in precision medicine, er… what?
For the majority of the readers on this blog, this is going perhaps a bit too much into detail. However, I’d quite like to steal an analogy by the legend-that-lives John Pfeifer, MD, PhD (Washington University School of Medicine). John – if you’re reading this, get in touch!
Cakes, yes cakes! John quite simply stole the show (well until a little later on, read on more to see why) with his cake analogy. With so many people being involved in the precision medicine movement including: geneticists, bioinformaticians, pathologists, lab managers and oncologists, why not include a baker? Good question John, good question indeed. With so many advancements in NGS (the focus of the FDA event), including: the mass of data (read my other post on bioinformatics), the sheer number of variants and different clinical applications, the need for reference materials became the clear outcome of day’s agenda. The FDA meeting focused mainly on this issue, and John described the use of two different standards: those by design, and those by performance to address the problem.
Still with me? Perhaps not, ok – let’s bring in his cake analogy.
What are design standards?
Imagine baking a cake, you need the essential ingredients (such as eggs, butter, chocolate and sugar) and a recipe to make them. If it’s your first time you’ll probably also need a helping hand from, let’s say your friend? Your friend will be there to guide you on: how, what and who should be putting the eggs into the bowl in order to achieve that cake they have been reading about on the internet for a whole week. I quite like to think of design standards as my girlfriend – a little bit patronising (I joke…). We’ve all been there.
Okay, so what are performance standards then?
Moving on, let’s say you don’t want your nagging partner there, back-seat baking youTM. What other options are there that were discussed at the FDA meeting?
Performance standards – This is perhaps slightly easier to comprehend. Imagine your partner is now telling you what she wants and her expectations of what the cake should taste like. The performance of the cake is critical. A good example of this would be looking at Gregg’s impression of the woman’s tart in the clip below. Going on Gregg’s reaction of the tart in this clip, the performance is fantastic, regardless of the contestant’s design:
Ultimately, it was concluded that testing and precision medicine needed to move forwards with a combination of both performance and design standards. It’ll be interesting to see how this news develops.
Also, in other news:
In other ground-breaking news at the FDA meeting, the woman in the picture below seemed to be having a whale of a time, rumor has it she had just heard that Qiagen had just released their new GeneReader system, alternatively she could just be excited about the bioinformatics slot on the agenda….no….really?
The FDA created a new sexy website
Yes really. The FDA have created a sexy website. Caveat: they want people. to. submit. their. performance. data. to. them. Erm, am i missing something? Who’s going to queue up to do this….?
Conclusions of the FDA meeting:
- We need a mixture of both performance and design based standards (aka everyone likes to bake cakes differently),
- We need to look at both external sources and a mixture of reference materials (aka you can’t be both the baker and the eater of the cake?) and;
- We need either research grants or more funding to progress (we need some better ingredients to bake this cake).
Disclaimers: The FDA is doing a great job. This blog is for research use only. Not for use in diagnostics procedures.
Main photo credit: Flickr Grace-ful Cakes