NOTTINGHAM, U.K.—Source BioScience has announced that it will provide drugmaker AstraZeneca with a companion diagnostic testing service for lung cancer patients in the United Kingdom.
This service will be funded by AstraZeneca and will allow clinicians in the National Health Service to identify whether lung cancer sufferers have activating mutations in their tumors making them sensitive to tyrosine kinase inhibitor therapies. Knowledge of the genetic status of the cancer will help clinicians determine the most appropriate therapy regime for lung cancer patients.
Financial terms of the agreement have not been made public.
According to Dr. Nick Ash, managing director at Source BioScience, the focus of the agreement is the timely provision of a sophisticated molecular diagnostic test that will assist in determining whether lung cancer patients should or should not be offered treatment with Iressa (gefitinib).
Under the agreement, Ash says Source BioScience will arrange transport of patient tumor samples as paraffin blocks from the referring physicians, cut sections, undertake histopathology review, extract DNA and then run a series of tests for a number of critical mutations of the EGFR gene. The results will be reported back to the physician electronically within five days. The work will be done at Source BioScience's Nottingham, U.K., facilities.
"We are delighted to enter this agreement with AstraZeneca and join the laboratories providing this type of diagnostic testing," Ash says. "It is our strategy to expand the range of diagnostic tests we provide and also migrate our extensive experience in genetic analysis into diagnostic testing for healthcare."
To support this, Ash points out that Source BioScience maintains first-class laboratory accreditations including Clinical Pathology Accreditation (CPA) for its molecular genetics services.
"Increasing demand for targeted therapies to improve treatment success and reduce costs is generating greater demand for companion diagnostics to accompany those therapies," he says. "The market for cancer diagnostics during 2010 is predicted to be in the region of $5.4 billion, with an increasing requirement for molecular diagnostics based on genetic analysis. If we are able to provide better diagnostic information for clinicians, this will help ensure that treatment pathways are managed more effectively, positively impacting the clinical outcome and cost effectiveness of therapy."
Each sample will undergo full pathology review prior to genetic testing, which will enable the tumor status to be determined, ensure that only tumor tissue is analyzed and guarantee the highest quality of diagnostic analysis and reporting.
Ash points out that the ultimate success of the agreement will be judged on turnaround times and percentage of successfully evaluated samples.
Other U.K. diagnostic companies, including Lab21 Ltd. and DxS Ltd., now owned by QIAGEN NV, are also providing tests for potential Iressa patients.
Source BioScience also last month released new tests to allow researchers to test for mutations in the NRAS and BRAF genes, conditions which are linked to certain cancers.
The company says it has developed the new pyrosequencing assays using its in-house expertise, with the tests being designed to be suitable for use with FFPE material. Mutations of NRAS and BRAF are found in those affected by a number of different cancer types, including melanoma, colorectal cancer and myeloid leukemia.
According to Source BioScience, the release of the NRAS test represents the first assay of its kind to be made available in the U.K.
It added that the launch of the new assays will allow for the analysis of cellular pathways, as well as assisting clinicians in developing new cancer treatments and categorizing patients for medical trials.
This service will be funded by AstraZeneca and will allow clinicians in the National Health Service to identify whether lung cancer sufferers have activating mutations in their tumors making them sensitive to tyrosine kinase inhibitor therapies. Knowledge of the genetic status of the cancer will help clinicians determine the most appropriate therapy regime for lung cancer patients.
Financial terms of the agreement have not been made public.
According to Dr. Nick Ash, managing director at Source BioScience, the focus of the agreement is the timely provision of a sophisticated molecular diagnostic test that will assist in determining whether lung cancer patients should or should not be offered treatment with Iressa (gefitinib).
Under the agreement, Ash says Source BioScience will arrange transport of patient tumor samples as paraffin blocks from the referring physicians, cut sections, undertake histopathology review, extract DNA and then run a series of tests for a number of critical mutations of the EGFR gene. The results will be reported back to the physician electronically within five days. The work will be done at Source BioScience's Nottingham, U.K., facilities.
"We are delighted to enter this agreement with AstraZeneca and join the laboratories providing this type of diagnostic testing," Ash says. "It is our strategy to expand the range of diagnostic tests we provide and also migrate our extensive experience in genetic analysis into diagnostic testing for healthcare."
To support this, Ash points out that Source BioScience maintains first-class laboratory accreditations including Clinical Pathology Accreditation (CPA) for its molecular genetics services.
"Increasing demand for targeted therapies to improve treatment success and reduce costs is generating greater demand for companion diagnostics to accompany those therapies," he says. "The market for cancer diagnostics during 2010 is predicted to be in the region of $5.4 billion, with an increasing requirement for molecular diagnostics based on genetic analysis. If we are able to provide better diagnostic information for clinicians, this will help ensure that treatment pathways are managed more effectively, positively impacting the clinical outcome and cost effectiveness of therapy."
Each sample will undergo full pathology review prior to genetic testing, which will enable the tumor status to be determined, ensure that only tumor tissue is analyzed and guarantee the highest quality of diagnostic analysis and reporting.
Ash points out that the ultimate success of the agreement will be judged on turnaround times and percentage of successfully evaluated samples.
Other U.K. diagnostic companies, including Lab21 Ltd. and DxS Ltd., now owned by QIAGEN NV, are also providing tests for potential Iressa patients.
Source BioScience also last month released new tests to allow researchers to test for mutations in the NRAS and BRAF genes, conditions which are linked to certain cancers.
The company says it has developed the new pyrosequencing assays using its in-house expertise, with the tests being designed to be suitable for use with FFPE material. Mutations of NRAS and BRAF are found in those affected by a number of different cancer types, including melanoma, colorectal cancer and myeloid leukemia.
According to Source BioScience, the release of the NRAS test represents the first assay of its kind to be made available in the U.K.
It added that the launch of the new assays will allow for the analysis of cellular pathways, as well as assisting clinicians in developing new cancer treatments and categorizing patients for medical trials.
