Exact Sciences won FDA approval for its stool-based colorectal cancer diagnostic, charting a regulatory milestone and picking up proposed national coverage for its product along the way.
Over the long holiday weekend, Dainippon Sumitomo's shares took a beating--dropping 21% at one point, according to Bloomberg--as investors reacted to the news that BBI608 proved to be a dud in its most advanced trial for colorectal cancer.
Qiagen gained FDA approval for a companion diagnostic test that will help spot patients with metastatic colorectal cancer who might benefit most from Amgen's drug Vectibix. The regulatory milestone represents another advance in the Dutch company's growing focus on personalized medicine.
Domain Associates' Elite enterprise is making its first investment in a China-focused company. The venture capital firm will sink $6.5 million into SMART Medical Systems, an Israeli developer and manufacturer of cost-effective endoscopy and colonoscopy products.
Exact Sciences won unanimous FDA committee approval for its stool-based cancer diagnostic, moving the company one step closer to receiving full regulatory clearance for the test.
Scientists continue to push for the development of a more precise, sensitive and cleaner colorectal cancer diagnostic. Now a research team has determined that a simple, at-home test already on the market is highly accurate.
Many new drugs these days are made with companion diagnostic tests in mind, and Amgen's treatment for metastatic colorectal cancer is no different. Illumina has inked a deal to develop a test that screens for patients who'd benefit most from the drug.
Quest Diagnostics' ongoing revamp continued this week with news that an Australian company has snatched up its colorectal cancer screening test business. Neither side is commenting on the financial details.
Quintiles, the world's largest CRO, has launched a study to determine whether preprofiling cancer patients for key biomarkers can ease trial enrollment and speed drug development.
The European Commission has stamped an approval on Stivarga (a.k.a. regorafenib) for aggressive cases of colorectal cancer, marking a regulatory victory for Bayer Healthcare and Onyx Pharmaceuticals ($ONXX). Amgen ($AMGN) benefits, too.