The company's recent license agreement with Abbott is part of its plan to move its Simoa technology into the clinic via partners in LDT and IVD development.
As labs without prior molecular testing or high-volume testing experience bring SARS-CoV-2 testing online, some are finding that an LIS upgrade is in order.
Questions around performance and a lack of clear clinical utility have hampered uptake, though improved standardization and vaccine launches could boost usage.
The payor says that the registry will provide needed transparency around test orders, but labs say it is an unnecessary burden, especially amidst a pandemic.
While the test is unlikely to be used as a diagnostic for the virus, it could be useful for identifying patients at high risk of developing severe disease.
While it is possible FDA could try to exert authority over such devices, observers suggest that past inconsistency and the recent HHS move make that unlikely.
