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HER2 Biomarkers

News and reporting on HER2 biomarkers.

An IASLC survey showed that molecular testing is not performed in line with expert guidelines, which means only a minority of lung cancer patients are benefitting from precision oncology.

Meeting presentations supported tweaking the clinical interpretation of Genomic Health's Oncotype DX and bolstered Biotheranostics' Breast Cancer Index.

The updated guidelines confirm HER2 gene amplification assessed by ISH and protein overexpression assessed by IHC are primary predictors of responsiveness to HER2 therapy.

Amid reporting a loss of about $2.0 million for the quarter, Celcuity also said that it had completed the development of its second test, for breast cancer, based on the CELx platform.

The firm's CEO said that by the end of the year, Celcuity will complete development of new cell-signaling function tests for breast and two other cancer types.

The control, being launched for the immunoassay-based tumor marker testing space, features HE4 and HER-2/neu, and outside the US, proGRP and SCC. 

Proceeds will go toward commercialization of its diagnostics, the development of additional diagnostic clinical trials, and the expansion of its operations.

The firm announced deals with Martell Diagnostic Laboratories and Immuno-Biological Laboratories to expand the access and use of the HER-2/neu test. 

Gencurix aims to achieve US FDA 510(k) clearance for its GenesWell BCT breast cancer prognostic test next year.

Eleven new recommendations were issued to address appropriate HER2 testing and clinical guidance in individuals with advanced gastroesophageal adenocarcinoma.