logo
  

Biocartis In Deal With AstraZeneca To Develop Companion Diagnostic Test For Tagrisso

Biocartis Group NV, a Belgium-based molecular diagnostics company, announced Wednesday that it has entered into an agreement with British drug major AstraZeneca Plc. (AZN,AZN.L) for the development and marketing of a companion diagnostic test for Tagrisso (osimertinib), a lung cancer therapy.

Tagrisso is AstraZeneca's third-generation EGFR-TKI (tyrosine kinase inhibitor) treatment approved for patients with resectable and locally advanced or metastatic NSCLC whose tumors have EGFR mutations.

Under the deal terms, Biocartis and AstraZeneca will co-lead the development and applicable pre-market notification or approval with the US FDA of a novel companion diagnostic or CDx test on Biocartis' molecular rapid and easy-to-use diagnostics Idylla platform, for use with Tagrisso.

The Idylla EGFR CDx Assay is intended to aid in identifying patients with non-small cell lung cancer or NSCLC who may respond to treatment with Tagrisso. The development of a companion diagnostic test on Idylla is expected to enable faster and broader patient access to Tagrisso treatment.

In addition to FFPE tissue, Biocartis will seek to validate the use of less invasive cytology samples such as fine needle aspirates for use with the Idylla EGFR CDx Assay, to expand patient access to testing.

The new project expands the companies' existing master collaboration agreement announced in January 2020, aimed at boosting access to faster molecular diagnostic biomarker results with the rapid and easy-to-use Idylla EGFR testing products.

Herman Verrelst, Chief Executive Officer of Biocartis, said, "Current EGFR molecular diagnostic testing remains a real challenge in the clinical practice. Obtaining high quality tissue samples is difficult and complex, especially in NSCLC where tumors are frequently very small, often leading up to several weeks of waiting time before results are available, as opposed to what we can offer with the Idylla technology."

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
Covid vaccine makers Pfizer Inc. and BioNTech SE announced a new $3.2 billion vaccine supply deal with the U.S. Government, as the country is bracing for a Covid outbreak this fall. Under the deal, the U.S. government will receive 105 million doses (30 µg, 10 µg and 3 µg) of Pfizer -BioNTech covid vaccines initially. The order may include adult Omicron-adapted COVID-19 vaccines. Samsung Electronics Co. has started the initial mass production of 3-nanometer or nm chips, which is considered as the most advanced chip in the world. In its move, the South Korean tech major beats rival Taiwan Semiconductor Manufacturing Co., the world's largest chip manufacturer, which is reportedly in the process to build one. Bryant Ranch Prepack Inc. is recalling certain Morphine Sulfate Extended-Release Tablets citing incorrect labeling, the U.S. Food and Drug Administration said. The recall involves one lot of Morphine Sulfate 30 mg Extended-Release tablets, and one lot of Morphine Sulfate 60 mg Extended-Release tablets to the consumer level.
Follow RTT