Put It on the Board

Create PDF

Oncomine Dx Target approved as CDx to aid in therapy selection for patients with RET mutations/fusions in thyroid cancers

October 2022—The Food and Drug Administration has granted approval to Thermo Fisher Scientific’s Oncomine Dx Target Test as a companion diagnostic to aid in selecting patients with RET-fusion-positive locally advanced or metastatic non-small cell lung cancer, RET-fusion-positive advanced or metastatic thyroid cancer, and RET-mutation-positive advanced or metastatic medullary thyroid cancer who may be eligible for treatment with Lilly’s Retevmo (selpercatinib).

This is the first approval for the Oncomine Dx Target Test as a companion diagnostic for a therapy targeting RET-positive thyroid cancer and the second approval associated with RET-positive NSCLC.

Initially approved in 2020, Retev­mo is a selective RET kinase inhibitor and was the first therapy approved for patients with advanced RET-driven lung and thyroid cancers. RET alterations are found in about two percent of patients with NSCLC, 60 percent of patients with medullary thyroid cancer, and 20 percent in other thyroid cancers.

Oncomine Dx Target is a next-generation-sequencing–based test that can detect multiple alterations at once from a small sample.

FDA clears Cobas Pure system for low- to mid-volume laboratories

Roche received 510(k) clearance from the Food and Drug Administration for its Cobas Pure Integrated Solutions. The compact and modular solution combines three technologies—clinical chemistry, immunoassay, and ion-selective electrode diagnostic testing—on a single platform.

Cobas Pure Integrated Solutions has a footprint of about 21 square feet. It is able to perform up to 870 tests per hour with access to Roche’s full clinical chemistry and immunochemistry assay menu. Within the first year after launch, the menu will include more than 186 diagnostic tests across a wide range of disease areas. Roche says the system operates seamlessly with its Cobas Pro Integrated Solutions for mid- to high-volume laboratories.

BD launches software for flow cytometry research

BD launched BD Research Cloud, a cloud-based software solution designed to streamline the flow cytometry workflow for higher-quality experiments and faster time to insight for scientists working across immunology, virology, oncology, and infectious disease monitoring.