Close Menu

More articles about Companion Diagnostics

A Phase III prospective study shows Vectibix combined with an irinotecan-based chemotherapy regimen improves progression-free survival in patients with wild-type KRAS tumors compared to chemotherapy alone. The study did not reach statistical significance for showing improvement in overall survival, however.

Despite a report that Novartis intends to resubmit its application for the painkiller Prexige to the US Food and Drug Administration with a companion genetic test, the Swiss drugmaker says it is not trying to relaunch the drug in the US market.

Dako's HER-2 tests may be used as companion diagnostics for Herceptin in treating stomach cancer.

Genentech will work with Dako in filing for clearance of the HercepTest and HER2 FISH pharmDx as companion diagnostics for Herceptin in treating patients with stomach cancer.

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.

DxS' TheraScreen EGFR29 Mutation Kit will be used to test the mutation status of patients' EGFR oncogene to identify their eligibility for treatment with Iressa.

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.

Horizon will develop a cell model panel that DxS will use to assess its KRAS testing kits.

Asuragen will identify and develop a companion diagnostic for a Biogen oncology drug.

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.

Celera granted Bayer Schering rights to five cancer-related drug targets while retaining in vitro diagnostic rights.

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.

Pages

Master's and doctoral students in the UK call on funding groups to extend their grants for the duration of the disruption caused by the COVID-19 outbreak, the Guardian reports.

Squid can make edits to their RNA within the cytoplasm of their axons, Science News reports.

The Chan Zuckerberg Initiative is putting $25 million toward COVID-19 treatment research, according to the Verge.

In Science this week: researchers engineer version of Cas9 that is nearly PAM-less, and more.