After more than five years working in precision medicine field, I would like to categorize PM (precision medicine) products into the following five levels. It should be noted that the categorization criteria is based on the most important part of every PM products: validation.
Level 0 is only propaganda without any product yet, not to mention any validation. If an organization releases their flyer pages before the real product comes out, this can be classified into Level 0, customers can never do a real test with Level 0 PM product.
Level 1 is in-house simple validation. For Level 1 PM product, it has been tested by simple validation, like simulated-data validation and public-data validation. The difference between Level 0 and Level 1 is that the latter has a real product.
Level 2 is in-house industry-based standard validation. For Level 2 PM product, it has been validated through consensus standard validation, like Guidelines for Validation of Next-Generation Sequencing–Based Oncology Panels1. For Level 2 PM product, it has been under thorough validation, the validation process is good, if the performance (eg. sensitivity and specificity) is also good, this product can be reliable.
Level 3 is peer-reviewed validation with a paper published. Unlike Level 1 and 2, Level 3 has been scrutinized by the domain experts rather than just in-house validation. The PM product reach Level 3 is highly recommended, most people would buy it.
Level X is IVD approval through FDA/CFDA. At this level, the PM product is endorsed by FDA/CFDA, which means the official health system is agreed with the whole validation process. MSK-IMPACT and F1CDx can be categorized into Level X PM product.
To be honest, all levels of PM products I have mentioned above exist in the world, especially in China. The reason is that precision medicine is an extremely new field and every company wants to pitch in it. Jack Ma has said that health and happiness are promising investing themes. As a typical representation of health, lots of money swarmed into precision medicine, created a large amount of NGS (next generation sequencing) companies and therefore PM products from Level 0 to Level X co-exist in the market. Even though it is a chaotic situation today, I believe that with FDA/CFDA continuously studying the cutting-edge knowledge, keeping pace with the whole industry, PM products will become increasingly standard and robust. At that day, the organizations which did not hold Level X PM products will soon become incompetent.
Even though today is not good enough, the future is definitely better than today. Hope every cancer patient could obtain good treatments in the future.
Jennings L J, Arcila M E, Corless C, et al. Guidelines for validation of next-generation sequencing–based oncology panels: a joint consensus recommendation of the Association for Molecular Pathology and College of American Pathologists[J]. The Journal of Molecular Diagnostics, 2017, 19(3): 341-365. ↩