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.
Lebanon-based Cryogene and its subsidiary will distribute the gene expression-based test for breast cancer recurrence in the region.
Agendia is launching a patient access program to position MammaPrint in clinics, while other test makers are taking a wait-and-see approach.
The MINDACT study of Agendia's MammaPrint has reported that using the tool could cut the use of chemotherapy in half.
Physicians relied on MammaPrint to decide whether patients scoring in the middle range for cancer recurrence risk with Oncotype DX should receive chemotherapy.
Noridian said it has identified new data that will "significantly impact" its proposed policy on biomarker tests for guiding adjuvant chemotherapy decisions.
The Chan Zuckerberg Initiative is investing in Cold Spring Harbor Laboratory's BioRxiv.
A study appearing in PLOS One finds that shortened consent forms don't affect clinical trial participants' understanding of the study.
The National Security Agency monitored signal intelligence for signs of "nefarious" genetic engineering projects, Gizmodo reports.
In Nature this week: barley genome sequenced, method for genotyping and phasing short tandem repeats, and more.