Lyme disease
The firm is expanding its plans from a Crohn's disease test to a broader GI differential diagnostic and continues to expect to launch its Lyme disease assay by year-end.
DiaSorin, Qiagen Obtain CE Mark for Lyme Disease Early Detection Test
The assay uses Qiagen's QuantiFeron technology and runs on the DiaSorin Liaison XL and Liaison XS automated immunochemistry testing platforms.
The test relies on using quantitative PCR to target genes encoded by prophages — viruses present in Lyme-causing bacteria, which can be easier to detect than the bacteria itself.
Gold Standard Diagnostics Nabs FDA Clearance for Lyme Disease Test
The test can be used in conjunction with other FDA-cleared Lyme enzyme immunoassays developed by GSD as part of a CDC-recommended modified two-tiered testing algorithm.
DiaSorin, Roche, Inova Diagnostics Receive FDA 510(k) Clearances in February
DiaSorin got the green light for its Liaison Anti-HAV chemiluminescent immunoassay to detect total antibodies to the hepatitis A virus.