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Adam covers proteomics and life science mass spectrometry for GenomeWeb.
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.
Reimbursement and liability issues will be impacted by FDA's decision, while LDT users could find it difficult to assess the quality of the new tests.
Vendors are running up against equipment, materials, and manufacturing shortages, but the first quarter of 2021 could see a dramatic ramp in capacity.
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.
The data demonstrates the complexity of the immune response to the virus and could be useful in the development of serology tests and vaccines.
Responses from more than 200 healthcare systems show familiar concerns around lowering testing costs but some optimism regarding the outreach space.
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.