The center will use Qiagen Clinical Insight to analyze, interpret, and report molecular screening of cancer patients to help identify targeted therapies and clinical trial options.
Novartis' alpelisib is the first PI3K inhibitor approved for advanced or metastatic breast cancer patients who harbor PIK3CA mutations.
The test will guide clinical decision making related to Inovio's DNA-based immunotherapy to treat cervical dysplasia caused by human papillomavirus.
The firm hopes for a decision from the FDA later this year for its breast cancer drug candidate alpelisib, following results from a late-stage trial.
Qiagen's test is intended to identify advanced bladder cancer patients with alterations in FGFR3 or FGFR2 genes and who are likely to respond to erdafitinib.
Qiagen's test detects the most frequently occurring somatic mutations in EGFR in less than four hours using real-time PCR on the Rotor-Gene Q platform.
The draft guidelines have intrigued industry players interested in pursuing labeling that would allow their CDx to direct treatment for a class of drugs instead of one drug.
Qiagen and Foundation Medicine will develop tissue- and plasma-based companion tests to identify best responders to the PI3K inhibitor alpelisib
The new approval will allow the use of Qiagen's Therascreen EGFR RGQ PCR Kit as a companion diagnostic for Pfizer's Vizimpro in NSCLC patients.
A new trial has compared the two most prominent tests, showing that both have clear predictive ability, but leaving several other questions unanswered so far.