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.
ASCO said MammaPrint should be used to inform decisions on withholding chemotherapy for these clinically high risk, HR-positive, HER2-negative breast cancers.
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.
The German Association of Gynecological Oncology included the breast cancer diagnostic in its annual update for cancer clinicians.
Agendia, which makes the MammaPrint test, called the report "disappointing" but thinks it still has a shot at landing wider reimbursement in Germany.
One group pointed out differences between study group characteristics, while the other wondered about the role of patient preference.
The US Food and Drug Administration has new guidelines that enable some gene and cell therapies to undergo expedited review, according to the New York Times.
Using gene drives to control invasive species might be too risky, an initial advocate of the approach says.
In Science this week: intellectual property experts argue patent battles such as the one over CRISPR are wasteful, and more.
Researchers have grown tumors in 3D cell cultures to better understand cancer, the Economist reports.