– Dr. Harsha K Rajasimha
In attending major conferences over the past 5+ years in the area of #precisionmedicine molecular diagnostics space, reimbursement issue and lack of payers interest has been a recurring theme. There are various community initiatives and consortia such as personalized medicine coalition, BIO has a focus area in #personalizedmedicine, #ACMG puts out guidelines on mutations related to inherited diseases, #NCCN provides excellent guidelines on somatic oncology mutations, #ASCO, a national biomarker quality alliance, college of American pathologists (#CAP), #AMP, etc.
“All these organizations/alliances are all doing excellent work in tracking success stories in precision medicine in diagnostics and drugs to show the obvious value of such products to patients and payers.”
However, payers continue to demand clinical validation and utility from each reference lab or company offering NGS based multi-gene tests for oncology and inherited diseases. Given that the common denominator in almost all CLIA validated tests for oncology and inherited diseases have a common set of genes and variants (mostly derived from literature and public datasets such as #COSMIC, #CLINVAR, etc.), can the community come together in a pre-competitive collaborative to demonstrate the utility of these genes / variants? By doing so, we separate out the validation and utility aspects of an assay. Laboratories will still need to do their own CLIA validation but the demonstration of clinical utility for these diagnostic, prognostic and pharmacogenomics biomarkers could be addressed collectively as a community.
Doesn’t this save us all a lot of time and money? Won’t this speed up the clinical adoption of precision medicine for the greater good of patients?Early players like GenomicHealth and Foundation Medicine have spent a good amount of time and money in showing validity, utility and value of genomics based assays in the clinic. Yet, newer and innovative startups that improve the current standard of care continue to require to demonstrate value of each of these assays – such a forced duplication of effort. Can >50% of the duplication be avoided through industry community consortia collaborating to show value of science and only be required to prove their analytical validity?
It seems like a win-all approach and a lot of credit goes to the community initiatives and alliances that have been putting out some of the success stories like Xalkori, Iressa, etc. Biopharma have realized the need for collaboration and cooperation in early pre-competitive space and have come together to form alliances such as Pistoia pharma alliance.
The big question is – will the payers come to the table and have willingness to engage with the clinical, academic and industry stakeholders in this pre-competitive collaboration in precision medicine MolDx?
Are there reasons why competitors would not want to cooperate in this space?
I have started reaching out to several individuals and organizations with this proposal and look forward to your comments and further discussion on the topic.