Novartis is developing a companion diagnostic for Prexige and is evaluating its submission strategy for the painkiller with health regulators around the world. Can the Swiss drug giant use pharmacogenomics to resurrect a drug that already bears the stigma of being rejected by the FDA for liver safety concerns?
AstraZeneca is working with DxS to commercialize a EGFR mutation test kit in Europe to identify the patient population most likely to benefit from treatment with non-small cell lung cancer drug Iressa. The company has announced no such plans in the US, where the FDA has restricted any new NSCLC patients from receiving the drug.
Asuragen is working with Biogen Idec to identify “a potential companion diagnostic test that may be used to select patients likely to respond to a Biogen Idec therapeutic candidate in clinical development.” However, Biogen Idec is keeping a tight lid on the project.
GSK and Abbott will develop a companion diagnostic for GSK's investigational MAGE-A3 immunotherapy. After discussions with the FDA, GSK believes the drug and diagnostic will be reviewed simultaneously, and labeling language for the drug will require genetic testing prior to treatment.
LabCorp's $107 million offer to acquire Monogram gives it access to molecular diagnostics and pharmacogenomic tests that are clinically validated and are free of regulatory challenges. Although Monogram wasn't looking to be acquired, the deal would allow broader marketing of its tests by using LabCorp's national infrastructure.
Under the partnership announced this week, DxS' RT-PCR technology will be joined with Exosome Dx's xOSO technology — which collects nucleic acids from blood exosomes — to develop blood-based companion diagnostics for detecting cancer gene mutations.
Without PGx-guided dosing information, it is unclear whether genetic testing to gauge Plavix response will go the same way as genetic testing for warfarin. At least one national insurer, Aetna, feels that the FDA did not provide enough information in the updated label to warrant coverage for the intervention.
Looking at approximately 326,000 SNPs in 1,053 Swedish subjects, the study is thought to be the first "sufficiently powered" trial to detect genome-wide significance of three SNPs. As a result, study authors note that "additional genes having a major influence on warfarin dose might not exist or be found in the near-term."
A paper appearing in today's issue of NEJM demonstrates that combining genetic and clinical data can improve stable warfarin dose predictions — especially for those taking high or low doses of the drug. Now, large clinical trials in the US and Europe are slated to test the effect such dosing improvements have on clinical outcomes.