Roche's HbA1c test, along with an immunoassay system from Shenzhen New Industries Biomedical, and a celiac test from Immco also received 510(k) clearance last month.
Anticipating a potential cut into its portfolio from competitors' mass specs, Roche said last week at AACC that it will develop its own mass spec-based analyzer in response.
The firm said that immunoassays had 19 years in a row of double-digit growth, driven in part by an automated workflow approach to achieving lab efficiencies.
The Ventana assay is an immunohistochemistry-based companion diagnostic that identifies ALK-positive NSCLC patients eligible for the Novartis drug Zykadia.
The CE-marked test enables health professionals to distinguish between HIV-1 and HIV-2, and runs on the fully automated Cobas 6800/8800 systems.
Thermo Fisher Scientific's PCT assay for the diagnosis of sepsis was among a few tests that received 510(k) clearance last month.
The test, which simultaneously detects MRSA and Staphylococcus aureus, is designed to run on the company's Liat PCR point-of-care platform.
Enzo's patent relates to modified nucleotides for diagnostic and therapeutic applications, and is central to separate ongoing lawsuits with diagnostic developers.
The fourth-generation assay is for the in vitro qualitative assessment of HIV-1 p24 antigen and antibodies to HIV-1 and HIV-2 in human serum and plasma.
As the diagnostics industry launches high-throughput systems to large labs for HbA1c testing, clinicians also see a market need for point-of-care testing.