Skip to main content
Premium Trial:

Request an Annual Quote

Biocartis, AstraZeneca Ink Companion Diagnostic Pact

NEW YORK – Belgian molecular diagnostics firm Biocartis said on Wednesday that it will develop a molecular test to identify patients with non-small cell lung cancer most likely to respond to AstraZeneca's Tagrisso (osimertinib) treatment.

According to Biocartis, the partners will work together to obtain US regulatory clearance of the companion diagnostic for Tagrisso, which is used to treat NSCLC patients who carry specific mutations. Tagrisso is AstraZeneca's third-generation EGFR tyrosine kinase inhibitor treatment.

Biocartis plans to validate the test, called Idylla EGFR CDx Assay, in formalin-fixed, paraffin-embedded tissue samples, as well as in cytology samples such as fine needle aspirates. The work builds upon an earlier agreement announced in January 2020.

Biocartis CEO Herman Verrelst said in a statement that the Idylla EGFR CDx Assay "may enable faster and broader patient access" to Tagrisso. He added that current EGFR molecular testing is a "real challenge" for clinicians and that obtaining high quality samples is "difficult and complex, especially in NSCLC where tumors are frequently very small," and that it can take several weeks for results to become available.

According to Verrelst, a companion diagnostic offered on Biocartis' automated, real-time PCR platform can change that dynamic.

Financial terms of the new agreement with AstraZeneca were not disclosed.

The Scan

Positive Framing of Genetic Studies Can Spark Mistrust Among Underrepresented Groups

Researchers in Human Genetics and Genomics Advances report that how researchers describe genomic studies may alienate potential participants.

Small Study of Gene Editing to Treat Sickle Cell Disease

In a Novartis-sponsored study in the New England Journal of Medicine, researchers found that a CRISPR-Cas9-based treatment targeting promoters of genes encoding fetal hemoglobin could reduce disease symptoms.

Gut Microbiome Changes Appear in Infants Before They Develop Eczema, Study Finds

Researchers report in mSystems that infants experienced an enrichment in Clostridium sensu stricto 1 and Finegoldia and a depletion of Bacteroides before developing eczema.

Acute Myeloid Leukemia Treatment Specificity Enhanced With Stem Cell Editing

A study in Nature suggests epitope editing in donor stem cells prior to bone marrow transplants can stave off toxicity when targeting acute myeloid leukemia with immunotherapy.