Both FDA-regulated and CE-in vitro diagnostic (IVD) marked, the NextSeq 550Dx instrument enables clinical laboratories to develop and perform a wide range of applications, from NGS IVD assays ...

oncoReveal ® CDx is a NGS based IVD kit that uses ... TKI therapy (class approval) in NSCLC and ERBITUX ® and VECTIBIX ® for KRAS in CRC. oncoReveal ® CDx has been FDA cleared on the Illumina ...

The FDA’s nod for the imaging agent, TLX007-CDx, now branded as Gozellix, has a long shelf life and needs less equipment and preparation compared to some other agents. The NDA for Gozellix had a March ...

With the FDA clearance ... in vitro diagnostics (IVD) products and laboratory-developed tests (LDT) qualify as medical devices and are therefore subject to pre-market approval.

The U.S. FDA’s approval of Telix Pharmaceuticals Ltd.’s kit for preparing ... has a long shelf life and needs less equipment and preparation compared to some other agents.