Last year, the Gottlieb-led FDA approved 25 new molecularly-defined drugs and expanded indications compared to 19 in the prior year, and issued a slew of guidelines important for the personalized medicine field.
The NGS assay is designed to help physicians to identify non-small cell lung cancer patients who may benefit from eight targeted therapies.
The institutes will send patients samples to Resolution Bioscience, which will sequence circulating tumor DNA to identify the genetic causes of drug resistance.
After a successful pilot that recruited 1,000 patients, NorthShore will now engage 10,000 people to receive Color's genomic testing in their primary care.
The New York Department of Health-certified tests are based on proprietary algorithms licensed from Columbia University, which offers them in the US.
By achieving certification for the assay, called PredictSure IBD, the Cambridge, UK-based firm can sell it for clinical use across Europe.
A study of the detection of potential adverse drug events or interactions found that using PGx information led to better prediction of serious issues, despite no significant change overall.
In the I-SPY 2 trial, investigators analyzed whether MammaPrint scores and BluePrint subtypes could help identify patients who would respond better to treatments.
The program, which includes OncoDNA, will evaluate the use of molecular diagnostic testing in personalizing treatments for cancer patients in Luxembourg.
The test is intended to identify patients with ROS1, NTRK, and ALK gene fusions for treatment with TP's investigational drug repotrectinib.