The College of American Pathologist's 11 recommendations cover quantitative image analysis in HER2 immunohistochemistry testing.
Roche plans to establish a CAP/CLIA-certified protocol for the assay and PhoenixMD will further refine its precision for identifying patients who may benefit from its RSK2 inhibitor.
NeoGenomics estimates that the more than 2,000 community oncologists represent a $2.5 billion testing opportunity. Its CEO called the segment a "strategic priority."
The researchers said the test could predict progression and prognosis among women with breast lesions and could be more reliable than tumor margin inspections.
In some instances, Ventana said, a retrospective review and retesting of clinical cases using the affected dispensers would be necessary.
Lunaphore's LabSat Frozen technology aims to automate biomarker-specific frozen section staining and enable performing IHC assays within minutes.
The researchers found that tumors expressing STAG2 as a biomarker are twice as likely to recur and progress toward muscle invasion and metastasis.
The alliance announced earlier this month merges extensive oncology testing services from NeoGenomics with PPD's global CRO capabilities.
The updated guidelines confirm HER2 gene amplification assessed by ISH and protein overexpression assessed by IHC are primary predictors of responsiveness to HER2 therapy.
The firm hopes the effort, recently described in the journal Oncotarget, will spur adoption of its testing services by oncologists, particularly in Europe, where it is determined to become a market leader.