Agendia

Although a draft guidance last month recommended against use of molecular tests to guide chemotherapy, the group's finalized decision is subject to price negotiation and other adjustments.

The NGS kit combines Agendia's MammaPrint 70-gene breast cancer recurrence risk test and its BluePrint breast cancer subtyping assay.

The hospital will run Agendia's new NGS test kit in its lab, comparing results with the firm's existing centralized MammaPrint test.

The institute will run the company's new NGS test kit in its lab, comparing results with Agendia's existing centralized microarray version of the two assays.

Companies are now expected to have their tests cleared by authorities for clinical use, and to bring their entire catalogs into line with the new regulations by May 2022.

This finding has the potential to expand the current utility of the panel to identify an important subgroup of people who would benefit from less treatment, the firm said. 

The companies will work together to develop a next-generation sequencing-based kit version of Agendia's molecular breast cancer diagnostics.

The payor has updated its medical policy to state that "the use of MammaPrint is considered medically necessary in women who are diagnosed with primary invasive breast cancer."

Gencurix aims to achieve US FDA 510(k) clearance for its GenesWell BCT breast cancer prognostic test next year.

Agendia said that the guidelines reflect MammaPrint's rank as the only multigene test to receive level 1A status, based on prospective, randomized data from the MINDACT clinical trial.

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