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ALK Biomarkers

News and reporting on ALK biomarkers.

Qiagen Expands Companion Diagnostic Portfolio
Qiagen has received approval of its Therascreen EGFR Mutation Detection Kit RGQ from Japanese regulatory authorities.

"With genomics, and pharmacogenomics, and all the other aspects of the cancers, we have to think of a different way than the randomized trial," said Patrick Loehrer, interim director of Indiana University's cancer center and a member of FDA's Oncology Drugs Advisory Committee.

Insight is developing the tests using TaqMan probes on Life Technologies' ABI 7500 Fast Dx real-time PCR system to help physicians monitor cancer patients for mutations and upregulation in the ALK gene in order to make more effective treatment decisions.

In the study, out of three patients with ALK gene rearrangements, two responded partially to Infinity's investigational drug IPI-504, and one experienced prolonged stable disease while on the treatment for 7.2 months and had a 24 percent reduction in tumor size.

"The drugs that are being associated with our diagnostic tests have market potential in existing sales in the multi-billions of dollars," Schatz said this week at an investor conference in New York.

Pfizer has previously touted PF-02341066 as "the first agent in clinical development that selectively targets a unique genetic feature of cancer cells." The drug is currently in Phase III trials, while Abbott is in the process of designing validating trials for a companion test with the capability to detect ALK gene rearrangements.

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Nature News writes that viral genomic surveillance in the US faces systemic issues.

President Joe Biden is seeking an increase in federal spending, including higher budgets for the National Institutes of Health and Centers for Disease Control and Prevention.

A small, early-stage trial of a combination therapy for brain cancer reports favorable responses in two patients, according to the Guardian.

In PLOS this week: sex-stratified genome-wide association study of chronic pain, sequencing data from Indigenous Mexican groups, and more.