The NIH launched ALCHEMIST (Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trials) to identify patients with early-stage lung tumors that harbor genetic changes in ALK and EGFR and evaluate whether drugs targeted against those changes can improve survival. Those with the genetic changes will be eligible for one of two treatment trials; all screened participants, regardless of their tumor's mutations, will be followed for 5 years.
The FDA issued final guidance on the development, review, and approval or clearance of companion diagnostics, which are tests used to identify patients who will likely benefit from treatment with a particular drug. The tests are commonly used to detect certain types of gene-based cancers.
On July 31, the FDA also notified Congress of its intent to publish a proposed risk-based oversight framework for laboratory-developed tests, which are designed, manufactured, and used within a single laboratory. The agency must wait at least 60 days from that date to publish the document.
UK-based Wellcome Trust announced that it will invest £27 million in a state-of-the-art genome-sequencing hub for Genomics England, the government's project to decipher 100,000 complete genetic codes. The funding will allow Genomics England to become part of the Wellcome Trust Genomics Campus in Hinxton, which is also home to the Sanger Institute, the European Bioinformatics Institute, and several small biotech companies.
The FDA approved Exact Sciences' Cologuard, the first stool-based colorectal screening test that detects the presence of red blood cells and DNA mutations that may indicate the existence of cancer or a precursor to cancer.
Ohio's Cleveland Clinic unveiled plans to build a $276 million, seven-story cancer center, which will bring all cancer-related services, including imaging, under one roof. The additional space will also allow the institution to increase the number of patients it can accommodate in clinical trials. Groundbreaking was anticipated at the end of September, with completion slated for early 2017.
For more news on cancer research, visit Cancer Discovery online at http://CDnews.aacrjournals.org.