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.
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.
Agendia is launching a patient access program to position MammaPrint in clinics, while other test makers are taking a wait-and-see approach.