Promising. However, it is unfortunate that the system for getting advanced biomarkers into clinical practice is too complex with numerous barriers. For example, almost all the insurance-covered SLE biomarkers are over 55 years old. CCP antibody is the newest covered one for RA, and its report is now 25 years old. The FDA and CMS need to revise their approval processes. Rheumatologists need to work on solutions, otherwise, our patients will continue to have delayed dxs, misdiagnoses, under-tx, high morbidity/mortality, & tx'd in a "trial and error." The ACR needs to do a better job supporting them; Key opinion leaders need to support their use and teach others to use them in daily clinical practice, etc. I hope others will become passionate about this topic, otherwise, biotech companies performing lab translational research will continue to go bankrupt (Immunarray with the SLE-key rule-out test, for example) or lose their patents only to allow Labcorp and Quest to offer the tests 10-20 years after biomarker discoveries (like Dr. Susan Manzi's CB-CAPS will in 2024). Currently, personalized medicine and translational biomarker research look great on paper but is not a reality.
Promising. However, it is unfortunate that the system for getting advanced biomarkers into clinical practice is too complex with numerous barriers. For example, almost all the insurance-covered SLE biomarkers are over 55 years old. CCP antibody is the newest covered one for RA, and its report is now 25 years old. The FDA and CMS need to revise their approval processes. Rheumatologists need to work on solutions, otherwise, our patients will continue to have delayed dxs, misdiagnoses, under-tx, high morbidity/mortality, & tx'd in a "trial and error." The ACR needs to do a better job supporting them; Key opinion leaders need to support their use and teach others to use them in daily clinical practice, etc. I hope others will become passionate about this topic, otherwise, biotech companies performing lab translational research will continue to go bankrupt (Immunarray with the SLE-key rule-out test, for example) or lose their patents only to allow Labcorp and Quest to offer the tests 10-20 years after biomarker discoveries (like Dr. Susan Manzi's CB-CAPS will in 2024). Currently, personalized medicine and translational biomarker research look great on paper but is not a reality.