An analysis of several multigene breast cancer recurrence signatures suggests that some tests may be better than others at assessing risk of late distant recurrence.
Although a draft guidance last month recommended against use of molecular tests to guide chemotherapy, the group's finalized decision is subject to price negotiation and other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 two companies are entering a partnership to introduce diagnostic tests using NanoString's nCounter technology in Japan, beginning with a lymphoma assay.
Clearbridge subsidiary SAM Laboratory will be the exclusive provider of NanoString's Prosigna breast cancer prognostic gene signature assay in certain countries.
Validation results presented at the Association for Molecular Pathology meeting demonstrate that the test can be implemented clinically, replacing existing FISH and PCR assays.
The company believes it can overcome its challenges, and highlighted strong continued interest from pharma despite a disappointing end to its Merck deal.
The company saw total revenues of $27 million and product revenues of $16.9 million, as it had estimated in preliminary earnings report last month.
In a note, Cowen analyst Doug Schenkel said the company has had trouble meeting its targets and suggested it pursue a strategic sale of its nCounter platform.
The firm estimated that its total revenue in the quarter was $25.9 million to $26.9 million with only $16.9 million coming from products and services.
Their study suggests that commercial IHC assays for PD-L1 can yield compatible and transferrable results if handled appropriately.