NEW YORK – Qiagen said on Monday that it has obtained CE marking for its Therascreen PIK3CA RGQ PCR kit to aid in identifying breast cancer patients with a PIK3CA mutation.

As such, the test is now commercially available in Europe. The real-time qualitative PCR assay is performed on Qiagen's Rotor-Gene Q MDx instrument and uses the company's QIAamp in vitro diagnostic DNA sample prep kits for formalin-fixed paraffin-embedded tissue and plasma.

The assay detects 11 clinically actionably PIK3CA mutations, which are estimated to be present in about 40 percent of hormone receptor-positive, HER2-negative advanced breast cancer cases. Qiagen has a worldwide co-exclusive license from Johns Hopkins University for PCR-based companion diagnostics based on detection of mutations in PIK3CA.



Qiagen codeveloped the test in collaboration with Novartis in the US as a companion diagnostic for alpelisib (Piqray). The assay received US Food and Drug Administration approval for this use in May.

"We are convinced that our Therascreen PIK3CA Kit … will provide a valuable testing option for those seeking new ways to combat advanced breast cancer," Jonathan Arnold, vice president and head of oncology and precision diagnostics at Qiagen, said in a statement.

The New York City Police Department will be removing DNA profiles from a local database if they are from people who were never convicted of a crime, the New York Times reports.

Science reports that accusations of sexual assault against a microbiome researcher has also led to questions about his academic certifications.

Wired reports that researchers are analyzing the DNA fish leave behind in water to study their populations.

In Science this week: comprehensive cellular map of the human thymus, evidence of admixture between the ancestors of Neanderthals and Denisovan and a 'superarchaic' population.

This webinar will discuss a study that used long-read transcriptome sequencing to explore the distribution of isoforms in colon cancer samples and their metastasis counterparts. 

This webinar will explain how the Clinic for Special Children in Strasburg, Pennsylvania, has transformed its DNA workflows to improve the diagnosis and treatment of genetic illnesses that are prevalent in the pediatric population of its community.

Since the publication of the “The Digital MIQE Guidelines: Minimum Information for Publication of Quantitative Digital PCR Experiments” (dMIQE) in 2013, there has been a large expansion of the applications of dPCR such as single nucleotide variations (SNVs) and copy number variations (CNVs) measurements associated with disease diagnostics.

This webinar will discuss data from a recent real-world comparison study evaluating performance of two cell-free DNA methodologies as first-line prenatal screens.

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