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MDx/CDx Focus: Abbott CDx for Janssen, Pharmacyclics' Lymphoma Drug; Covance, M2Gen Collaborate


Abbott's FISH Test to be Developed into CDx for Janssen, Pharmacyclics' Lymphoma Drug Ibrutinib

Abbott, Janssen Biotech, and Pharmacyclics are working together to develop a companion molecular diagnostic to identify chronic lymphocytic leukemia patients who are likely to respond to ibrutinib.

Ibrutinib, a small-molecule inhibitor of Bruton tyrosine kinase, is being developed by Janssen and Pharmacyclics as a treatment for leukemia and lymphoma. Abbott's Vysis fluorescence in situ hybridization probe kit for CLL will be used to identify patients who have a deletion within chromosome 17p and may respond to ibrutinib.

"Patients harboring a deletion within chromosome 17p are poor responders to chemoimmunotherapy and have limited treatment options," Abbott said in a statement. "Having a test that is able to accurately detect the 17p deletion identifies a specific patient population with a high unmet medical need."

The US Food and Drug Administration in 2011 green-lighted Abbott's Vysis CLL FISH Probe Kit. The test gauges multiple genes, including TP53, which is located within the del17p region, and is used to assess disease prognosis in CLL.

The test will be used with investigational-use-only status as part of clinical trials for ibrutinib. Pharmacyclics is currently conducting Phase I/II trials involving ibrutinib in CLL and small lymphocytic lymphoma. The drug has shown efficacy in relapsed or refractory CLL patients, with mild to moderate side effects.

Outside of the CLL indication, the drug has been placed into the "breakthrough category" by FDA, a new designation for drugs that will receive a quick review within the agency. The breakthrough designation evolved from a provision in the FDA Safety and Innovation Act, and the agency is in the process of crafting guidance around how a drug receives this designation. Ibrutinib has breakthrough status as a monotherapy in patients with relapsed or refractory mantle cell lymphoma who have received prior therapy, and in patients with Waldenström’s macroglobulinemia.

Covance, M2Gen Collaborate to Speed Development of Personalized Cancer Drugs

Covance and Moffitt Cancer Center subsidiary M2Gen are collaborating to launch a service through which biopharma clients can match patients to biomarker-guided oncology studies and accelerate their drug development timelines.

Under the terms of the exclusive alliance, Covance will be M2Gen's preferred provider of DNA/RNA sequencing, gene expression analysis, and genotyping services. Covance will conduct these analyses in its genomics lab in Seattle, Wash.

M2Gen, meanwhile, houses a specimen repository with clinical and molecular data on 95,000 consented patients from Moffitt's 17 hospitals. M2Gen also has a proprietary healthcare informatics platform that will be used to match patients to clinical trials. This, the partners are hoping, will "significantly reduce the timeline for identifying suitable participants for enrollment in clinical trials and improve the design of biomarker-driven trials."

According to Covance, over the last five years it has conducted more than 130 trials across various tumor types for drug companies. In working with M2Gen, Covance is hoping to strengthen its footprint in the personalized medicine space.

M2Gen and Moffitt Cancer Center plan to add new hospitals to their network in an effort to expand clinical data access to more consenting patients.

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.