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News and reporting on HER2 biomarkers.
Under the terms of the agreement Thermo Fisher will retain the rights to commercialize the companion test globally and seek regulatory approval.
The test detects the HER2 biomarker in breast cancer and can be completed within the same day, allowing for faster results than other HER2 testing methods.
At the American Society of Clinical Oncology's virtual meeting, investigators presented two new studies of BluePrint classification patterns.
Celcuity's companion diagnostic platform CELsignia identifies cellular signals corresponding to drug response using a patient's living tumor cells.
The high-throughput S2000 sequencer is the second instrument Genetron Health has received NMPA approval for, following the S5 benchtop instrument last year.
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.