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Abbott seeks leukemia test

pharmafile | February 25, 2013 | News story | Sales and Marketing AbbVie, Abbott, Janssen 

Abbott is to team up with Janssen Biotech and biopharma firm Pharmacyclics to seek a diagnostic test for leukemia patients.

The trio of companies will see if Abbott’s FISH (fluorescence in situ hybridization) technology can be used to develop a test which would then be used in conjunction with a drug Janssen and Pharmacyclics are developing.

The goal is to identify patients with a genetic subtype of chronic lymphocytic leukemia (CLL), the most common form of adult leukemia.

Abbott’s part of the deal is to develop a FISH-based molecular companion diagnostic test to identify high-risk CLL patients who have a deletion within chromosome 17p (del17p).

It is hoped that this patient group, which has a generally poor response to chemoimmunotherapy and limited treatment options, may respond to Janssen and Pharmacyclics’ ibrutinib. 

This is an oral, small molecule inhibitor of Bruton tyrosine kinase (BTK) which the companies are testing in B-cell malignancies, including chronic leukemia and lymphoma.

“Our goal is to leverage molecular technologies to help ensure that the right medicine is getting to the right person,” said John Coulter, vice president of molecular diagnostics at Abbott.

“Cancer is a complex disease where, historically, therapies have demonstrated only a 25% efficacy rate,” he went on.

Companion diagnostic tests select patients who are more likely to respond to specific treatments, thereby increasing the chance of positive outcomes and complementing pharma’s trend for personalised medicines.

FISH works well in dentifying genetic markers in solid tumours, which makes cancer diagnostics an obvious application.

The technology can identify whether there are too many – or too few – copies of a particular gene present in cells and whether some genes have rearrangements playing an active role in disease progression. 

Diagnostics is a key area for Abbott, which split from AbbVie at the start of this year: it already has FDA approval for its Vysis CLL FISH Probe Kit, which targets multiple genes.

These include TP53 (tumour protein p53 gene, located on chromosome 17p) within the del17p region, with the kit used to determine the prognosis of CLL patients.

In the agreement with Janssen and Pharmacyclics it will be used only to determine genetic marker status.

The American Society of Clinical Oncology has suggested that future cancer therapies will be developed through the sorts of approaches which can pinpoint more personalised treatments.

Identifying such specifics is expected to help the development of new drugs targeting specific proteins which cause the growth of cancers.

And oncology is not the only area in which hopes are being pinned on such tests: Eli Lilly’s diagnostic radiopharmaceutical Amyvid has recently been approved in Europe and the US to assess whether patients have Alzheimer’s disease. 

Adam Hill

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