How We Can Support the Drug Development Pipeline

Cancer Portfolio

• Breast
• Colorectal
• Lung
• Leukaemia and Lymphoma

Breast

The portfolio incorporates a range of tests to profile tumour providing valuable information to stratify patients for clinical trials, or as an aid to companion diagnostics following drug launch. This portfolio includes:

Histology & path Review

Histological/By eye analysis of biopsy by a consultant histopathologist recording size of tumour, grade and stage.

ER/PR

The growth of some tumours is increased by certain hormones present within the body. ER/PR analysis is carried out to assess whether the tumour is likely to be sensitive to the sex hormones oestrogen and progesterone. A positive test result means that the tumour is very likely to respond to Tamoxifen and/or drugs known as aromatase inhibitors which block the conversion of other hormones in the body to oestrogen. This test is a requirement for the prescribing of these drugs.

HER2

In a proportion of breast cancer patients (about 20%) HER2 is present on the cancer cells. When epidermal growth factor combines with the HER2 protein, it can stimulate cancer cells to grow. The drug Herceptin™ can prevent such growth but is only effective when the HER2 protein is present in sufficient quantities i.e. in 20% of patients. This test therefore is a requirement for the prescription of Herceptin™. All women in the UK diagnosed with early or advanced breast cancer are eligible for Herceptin™ treatment, subject to the result of this test showing that they fall within the 20% of patients with HER2 protein. These tests for ER/PR and HER2, are regarded as essential to any breast cancer evaluation. Source BioScience can provide these tests together with scoring indices using a computer program which can provide further information on drug efficacy for clinical trials.

Other Tissue Biomarkers

Source BioScience has a very comprehensive portfolio of tissue based biomarker assays which can be used to aid research and clinical studies in colorectal and other cancers. These include total protein and phosphorylated markers. Since these assays have been validated, they are cost effective and rapid saving you precious time. For further information please go to Biomarker Assay Development.
We would be happy to discuss your requirements with you over the phone and help you to write study protocols. We also provide formalin kits for collection of tissue samples for clinical trials as well as site manuals.

To discuss your needs please call us on :+44(0)115 973 9012.
Or email us on:   pharma

TOP2A

The TOP2A test can be used to predict whether a tumour is likely to respond favourably to anthracycline-based chemotherapy, and is another tool which can be used in clinical trial studies.

Protein Expression Class Typing

Recent studies of gene profiling in breast cancer have shown that this disease can be classified into five distinct groups, each of which has distinct biological characteristics which relate to patient outcome.

BRCA1 Mutation Risk Prediction

Women with mutations in the BRCA1 gene are three times more likely to develop breast cancer than those in the general population. Source BioScience can identify and stratify those individuals which are at high risk of carrying this mutation and maybe a useful adjunct for clinical trial or clinical research studies.

CTCs (Circulating Tumour Cells)

CTCs can be used to diagnose, monitor and aid prognosis of disease including Breast cancer. For further information, please go to CTC.

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Colorectal

Source BioScience uses a range of tests to profile tumour providing valuable information to stratify patients for clinical trials, or as an aid to companion diagnostics following drug launch. This portfolio includes:

Histology & path Review

Histological/By eye analysis of biopsy by a consultant histopathologist recording size of tumour, grade and stage

EGFR

Source BioScience can provide a full complement of tests for EGFR evaluation including IHC, FISH and mutation analysis. For more information please go to  EGFR.

Other Biomarkers

Source BioScience has a very comprehensive portfolio of tissue based biomarker assays which can be used to aid research and clinical studies in colorectal and other cancers. These include total protein and phosphorylated markers. Since these assays have been validated, they are cost effective and rapid saving you precious time. Please go to Biomarker Assay Development further information.

We would be happy to discuss your requirements with you over the phone and help you to write study protocols. We also provide formalin kits for collection of tissue samples for clinical trials as well as site manuals.

Contact:
Email:   pharma
Telephone:   +44(0)115 973 9012

KRAS

Source BioScience is a UK preferred supplier for KRAS mutation detection on DNA extracted from paraffin-embedded clinical material. The test includes a histopathology review of the sample to ensure tumour tissue is present. Macrodissection of tumour can also be provided.

Recent studies in non small cell lung cancer and colorectal cancer show that activating mutations of the gene encoding the signalling molecule KRAS, are likely to give rise to resistance to:

• small molecule drugs e.g. (erlotinib; gefitinib) and
• antibody treatments e.g. (cetuximab, panitumumab) targeted at the Epidermal Growth Factor Receptor (EGFR)

This is because KRAS lies downstream in the EGFR signalling pathway and therefore, if it is continuously active based upon the presence of a mutation in the KRAS gene, inhibition of EGFR by the drugs listed above will be ineffective.

Testing for KRAS activating mutations may therefore offer further refinement to the treatment decision-making process, separating patients according to likely response to these agents. Serial sections are cut from the paraffin block and DNA extracted. Mutations are then detected using assays can detect very low levels of mutant DNA in a background of wild type genomic DNA.

A positive result in this test indicates the presence of an activating mutation in the KRAS gene, and suggests that this patient is unlikely to respond favourably to treatment with small molecule or antibody treatment targeted at EGFR.

We offer testing using the DXS TheraScreen test and Pyrosequencing.

BRAF

BRAF is a protein kinase enzyme which plays a key part in cell signalling leading to cell proliferation. Mutations in the BRAF gene cause cells to continuously multiply which can lead to cancer.
BRAF V600E is the commonest mutation and is seen in melanoma, thyroid and lung cancers. It has also been implicated in Colorectal cancer where patients wildtype for KRAS may still have a BRAF mutation rendering treatment with agents such as Cetuximab ineffective.
Source BioScience provides a sequencing service to detect BRAF mutations to aid drug development and research studies.

PI3K

PI3Kinase mutations have been shown in approximately 32% of patients with CRC. Activating mutations in exons 9 and 20 of the PI3KCA oncogene have been observed in a number of important cancer types including gastrointestinal, breast, liver, lung and genito-urinary cancers. The presence of such mutations may prove useful as a tool to stratify patients for clinical trials.

CTCs (Circulating Tumour Cells)

CTCs can be used to diagnose, monitor and aid prognosis of disease including Colorectal cancer. For further information please go to on CTC.

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Lung

The importance of mutation analysis in Lung cancer treatment has been realised recently with the Committee for Medicinal Products for Human Use (CHMP), the scientific advisory committee of the European Medicines Agency (EMEA), supporting the approval of the targeted oral anti-cancer drug, Iressa (gefitinib) for those with activating mutations of EGFR-TK.

A mutation in EGFR occurs in approximately 10-15% of lung cancers in Europe, and studies have shown that these types of tumours are particularly sensitive to Iressa. There are approximately 106,000 new cases of advanced lung cancer in Europe (top 5 countries) per year.

Other mutations which can affect treatment therapies include KRAS and BRAF.

Source BioScience uses a range of molecular and tissue based tests to profile lung cancer providing valuable information to stratify patients for clinical trials, or as an aid to companion diagnostics following drug launch. This portfolio includes:

Histology & path Review

Histological/By eye analysis of biopsy by a consultant histopathologist recording size of tumour, grade and stage. We can also provide automated image analysis services with quantitative expression analysis of biomarkers.

EGFR

Source BioScience can provide a full complement of tests for EGFR evaluation including IHC, FISH and mutation analysis. For more information please go to EGFR.

Mutation Analysis

We offer a range of mutation tests for molecular markers including BRAF,KRAS, EGFR and PI3K. For further information please go to Molecular Test Portfolio.

We also offer FcGamma receptor genotyping important in response to erbitux and vectibix.

Other Biomarkers

Source BioScience has a very comprehensive portfolio of tissue based biomarker assays which can be used to aid research and clinical studies in colorectal and other cancers. These include total protein and phosphorylated markers which may be important in Lung and other cancers including MAPK, pERK and survival pathways (pAKT; PTEN). Since these assays have been validated, they are cost effective and rapid saving you precious time. For further information please go to Biomarker Assay.

We would be happy to discuss your requirements with you over the phone and help you to write study protocols. We also provide formalin kits for collection of tissue samples for clinical trials as well as site manuals.

CTCs (Circulating Tumour Cells)

CTCs can be used to diagnose, monitor and aid prognosis of disease including Lung cancer. For further information please go to CTC.

Contact:
Email:   pharma
Telephone:   +44(0)115 973 9012

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Leukaemia and Lymphoma

SourceBioScience uses a range of tests to profile tumours providing valuable information to stratify patients for clinical trials, or as an aid to companion diagnostics following drug launch. This portfolio includes:

Histology & Path Review

Histological/By eye analysis of biopsy by a consultant histopathologist recording size of tumour, grade and stage as well as confirmation of tumour status. For further information please go to Histology & Path Review.

Biomarker analysis

Source BioScience has a very comprehensive portfolio of tissue and blood based biomarker assays which can be used to aid research and clinical studies for lymphomas, leukaemias and other cancers. These include total protein and phosphorylated markers as well as CD markers, cyclins, BCl and others. Many of these assays have been validated making them cost effective and rapid, saving our clients time and money. For further information please go to biomarker assay development.

We would be happy to discuss your requirements with you over the phone and help you to write study protocols. We also provide formalin kits for collection of tissue samples for clinical trials as well as site manuals and genomic extraction services.

To duscuss your needs please call us on : +44(0)115 973 9012.
Or email us at: pharma.

MDM2 FISH

P53 is a transcriptional activator regulating expression of MDM2. MDM2 overexpression is seen in certain lymphomas and is associated with poorer survival. It may therefore be useful as a prognostic indicator. Source BioScience can provide MDM2 and p53 testing as required.

Mutation analysis

JAK

The Janus kinases or Jak kinases include four different enzymes (Tyk2, Jak1, Jak2, Jak3) that share significant structural homology with each other. They play an important role in interferon and cytokine signalling, and mutations in JAK are known to be associated with high relapse rates in certain malignancies such as acute lymphoblastic leukaemia or ALL. Since ALL is the second leading cause of cancer death in children, there has been a lot of interest in mutation analysis to predict response to treatment. JAK2 V617F mutation in exon 14 has been associated with myeloproliferative disorders associated with blood neoplasms. Source BioScience offers JAK mutation analysis to support both clinical and research studies using rtPCR amplification targeting relevant regions of JAK2 or MPL, followed by amplicon sequencing and bioinformatics analysis to determine the presence of mutations.

Using our GLP,GCP,CPA accredited facilities, we can provide a range of mutation analysis testing to suit your project requirements. This includes BCL mRNA level ratio of transcripts compared to normal controls.

Whole genome analysis of genes of interest such as p53 can also be carried out using next generation sequencing using the Illumina platform. For further information please go to WGA.

CTCs (Circulating Tumour Cells)

CTCs can be used to diagnose, monitor and aid prognosis of disease and may be of use in blood related cancers. For further information please go to CTC.

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