On the first of this year, clinical laboratories began billing for more than 100 molecular pathology tests using new CPT codes, which replaced the previous stacked-code system.
The transition has already been rocky—the U.S. Centers for Medicare & Medicaid Services (CMS) has asked local administrative contractors to develop their own payment rates. The change has also stirred up concern over the fate of molecular testing in the clinical setting as R&D initiatives press on in the pursuit of personalized medicine.
“It is very exciting to see how much progress we are making so, in the future, we can end up with better patient care. To make these tests available to a wider audience they need to move from a Research Use Only (RUO) status to a clinical one,” says Olive Joy Wolfe, president, Clinical Consultants, of the speakers at CHI’s recent “Biomarkers and Diagnostics World Congress”.
“This may require collaboration across laboratories, working with groups like the NCI [National Cancer Institute], and working closely with the FDA early on to facilitate the process. The first question is defining the use of the test. Is it for diagnostics, therapy choices, patient intervention, or something else?”
Biomarker assays can be multiplexed and performed on complex platforms and instrumentation that the average laboratory technician may be unfamiliar with. In addition, if the assay is multistep, it may require a combination of instruments and techniques.
As MD Anderson Cancer Center’s Samir Hanash, Ph.D., notes, in a discovery mode, the sensitivity that can be achieved for cancer protein biomarkers by mass spectrometry is quite deep. The challenge is to come up with implementable assays that achieve the same level of sensitivity.
“You need samples first to test the process, then if you are taking it to the next level and looking at further development for determining biomarker values in the clinical setting you have to go through validation, just as for any other assay under the CLIA rules,” adds Wolfe.
“It is not as simple as it was before, but there are guidelines. It will not be as foreign to researchers who went through several of these necessary steps when we first came up with other methodologies, such as the RIA [radioimmunoassay], because they are aware of the work involved,” she says. “Yet, it is more complicated because we may be looking at multiplex proteomic-based tests.”