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Two new studies revealed the prevalence of pathogenic variants in breast cancer-related genes, while highlighting genes that may be most informative in the clinic.
The partnership aims to develop a test that will determine which patients with advanced colorectal cancer will not respond to standard treatment.
Researchers have already dosed the first patient with TG4050 and expect to give the immunotherapy to up to 30 more patients in the Phase I study.
Natera alleges Inivata infringes its US Patent Nos. 10,262,755 and 10,597,709, which cover cancer monitoring and molecular residual disease testing.
The expert body now recognizes the test's ability to predict whether early-stage breast cancer patients will benefit from extended, adjuvant endocrine therapy.
The final decision includes some changes, most notably removing requirements for guideline inclusion, but retains its technical performance benchmarks.
The company has reached agreements with investors for a direct offering of 2.2 million shares at $1 per share, for gross proceeds of about $2.2 million.
The agency approved the new indication based on data showing that the drug improved survival in patients compared to chemotherapy.
The agency approved the drug based on a study that showed an 88 percent response rate in young patients with ALK-positive anaplastic large cell lymphoma.
The precision oncology company plans to use the proceeds to advance drugs in its pipeline, improve its RADR platform, and acquire new therapeutic assets.