Internal Diagnostic and Companion Diagnostic Development


	INTERNAL DIAGNOSTIC AND COMPANION DIAGNOSTIC DEVELOPMENTWe’ve already demonstrated our ability to discover and develop biomarkers across multiple disease areas within our internal R&D and product development team. We also have an exciting pipeline with both internally developed diagnostic and multiplex companion diagnostic tests.

Please see details of our current tests and pipeline in the tabs below.

The Subtyping Approach

In our internal research we take a subtyping approach to biomarker discovery. This involves profiling large retrospective datasets to identify the underlying subgroups that represent fundamental biology. This approach can be used for the discovery of biomarkers in a wide range of indications – and when it is, the biology discovered represents a class effect that can often be seen in multiple disease areas. We take the subtyping approach with our own R&D and we’ve also used it with a number of clients for whom clinical trials had previously been run.

The Multiplex Approach

This approach to developing diagnostics and companion diagnostics emerges from a more fundamental understanding of the molecular basis of a disease. It takes account of the fact that there are a multitude of factors – genetic mutations, gene expression and the interplay of metabolic pathways – that determine the cellular response to any given pharmaceutical.

The challenge is to find and exploit them all simultaneously – to produce a single test that indicates whether a patient will respond to a specific drug or not. Although the science can be complex, the practical clinical solutions remain simple. We have already proven the diagnostic potential of the multigene signature approach, and we’re able to support pharmaceutical clients in the discovery, development and commercialization of a multiplex companion diagnostic. Ultimately, this makes it an accessible testing service to clinicians.


More Details

DDRD
AADx
ColDx
Almac's Biomarker Pipeline
Quality Assurance

DDRD

Almac DDRDAlmac’s Predictive DNA Damage Response Deficiency (DDRD) Assay

Almac has used its expertise to develop a multiplex diagnostic test that can predict outcomes when using DNA damaging drugs such as Anthracycline and Cyclophosphamide. As such, the test is not specific to one drug, but to a whole class of DNA damaging drugs, and indeed, a whole range of cancers in which DNA damage is a factor.

We profiled patient samples in order to understand the underlying biology that would indicate response/no response to DNA damaging drugs. More specifically, we set out to develop an assay to detect DNA damage response (DDR) deficient tumors associated with loss of the FA/BRCA pathway. We developed a 44-gene microarray-based assay (the DDR deficiency (DDRD) assay) to prospectively identify the responsive subgroup from formalin-fixed, paraffin-embedded (FFPE) samples.

Our publication ‘Identification and Validation of an Anthracycline/Cyclophosphamide–Based Chemotherapy Response Assay in Breast Cancer in the Journal of the National Cancer Institute details the discovery and independent validation of the DDRD assay.


AADx

Almac AADxAlmac’s Angiogenesis Biomarker in Ovarian Cancer

Almac have identified and validated a powerful biomarker in ovarian cancer. The AADx gene expression biomarker identifies a molecular subgroup of patients that has better survival following standard chemotherapy but may be disadvantaged by bevacizumab (Avastin).

Almac initially presented the identification of this molecular subgroup at ASCO 2011 and have now validated the signature in the ICON7 dataset. The AADx signature identifies a subgroup have a good prognosis following standard of care chemotherapy. This good prognosis subgroup exhibited worse progression free and overall survival following the addition of bevacizumab within the ICON7 translational dataset. Patients whose tumours fell outside of this molecular subgroup exhibited a trend towards improved progression free survival.

This assay could potentially be used as a companion diagnostic for any anti-angiogenic agent in any cancer.

This validation study was presented by Dr. Charlie Gourley from the University of Edinburgh at ASCO 2014.
Almac is now seeking to perform additional validation studies of the test in HGSOC as well as in other cancer types. Almac believes that the test will also work for other anti-angiogenic compounds that function in a similar manner as well as for other diseases.

View Dr Gourley’s presentation in the ASCO Daily News ‘Gene Signature May Help Stratify Patients for Bevacizumab Therapy in High-Grade Serous Ovarian Cancer’


ColDx

Almac ColDxAlmac’s Breakthrough Biomarker for Stage II Colon Cancer

This true example of a powerful multiplex signature involves a 634–probe set signature that can identify patients at high-risk for recurrence and/or high risk for cancer-related death. Additionally, the signature has been shown to perform independently from known prognostic factors.

This work was first reported in ASCO’s Journal of Clinical Oncology in 2011. More recently, in January 2014, The Alliance for Clinical Trials in Oncology announced results of a study performed in conjunction with Almac and Helomics Therapeutics Inc.®, which confirmed that the ColDx assay is a significant, independent predictor of recurrence-free interval (RFI) in stage II colon cancer. This external validation proves that the method is transferable and robust.

This test has now been launched in the US by Helomics Therapeutics Inc.® as GeneFX colon, and will help identify those patients at greatest risk of cancer recurrence, for whom chemotherapy may be a useful option following surgery.

View the Journal of Clinical Oncology publication ‘Development and Independent Validation of a Prognostic Assay for Stage II Colon Cancer Using Formalin-Fixed Paraffin-Embedded Tissue’.


Almac's Biomarker Pipeline

Almac’s Biomarker Pipeline

 


Quality Assurance

Almac Diagnostics is accredited by:

• UKAS to ISO17025 (accreditation number 2740)
• CLIA
• College of American Pathologists (CAP)
• New York State (CLEP Permit)
• Almac also holds individual US State licenses for Florida, California and Pennsylvania

Almac Diagnostics holds ISO13485 certification (SGS) and also complies with GLP, GCP and GCLP.




More Details

DDRD
AADx
ColDx
Almac's Biomarker Pipeline
Quality Assurance

DDRD

Almac DDRDAlmac’s Predictive DNA Damage Response Deficiency (DDRD) Assay

Almac has used its expertise to develop a multiplex diagnostic test that can predict outcomes when using DNA damaging drugs such as Anthracycline and Cyclophosphamide. As such, the test is not specific to one drug, but to a whole class of DNA damaging drugs, and indeed, a whole range of cancers in which DNA damage is a factor.

We profiled patient samples in order to understand the underlying biology that would indicate response/no response to DNA damaging drugs. More specifically, we set out to develop an assay to detect DNA damage response (DDR) deficient tumors associated with loss of the FA/BRCA pathway. We developed a 44-gene microarray-based assay (the DDR deficiency (DDRD) assay) to prospectively identify the responsive subgroup from formalin-fixed, paraffin-embedded (FFPE) samples.

Our publication ‘Identification and Validation of an Anthracycline/Cyclophosphamide–Based Chemotherapy Response Assay in Breast Cancer in the Journal of the National Cancer Institute details the discovery and independent validation of the DDRD assay.


AADx

Almac AADxAlmac’s Angiogenesis Biomarker in Ovarian Cancer

Almac have identified and validated a powerful biomarker in ovarian cancer. The AADx gene expression biomarker identifies a molecular subgroup of patients that has better survival following standard chemotherapy but may be disadvantaged by bevacizumab (Avastin).

Almac initially presented the identification of this molecular subgroup at ASCO 2011 and have now validated the signature in the ICON7 dataset. The AADx signature identifies a subgroup have a good prognosis following standard of care chemotherapy. This good prognosis subgroup exhibited worse progression free and overall survival following the addition of bevacizumab within the ICON7 translational dataset. Patients whose tumours fell outside of this molecular subgroup exhibited a trend towards improved progression free survival.

This assay could potentially be used as a companion diagnostic for any anti-angiogenic agent in any cancer.

This validation study was presented by Dr. Charlie Gourley from the University of Edinburgh at ASCO 2014.
Almac is now seeking to perform additional validation studies of the test in HGSOC as well as in other cancer types. Almac believes that the test will also work for other anti-angiogenic compounds that function in a similar manner as well as for other diseases.

View Dr Gourley’s presentation in the ASCO Daily News ‘Gene Signature May Help Stratify Patients for Bevacizumab Therapy in High-Grade Serous Ovarian Cancer’


ColDx

Almac ColDxAlmac’s Breakthrough Biomarker for Stage II Colon Cancer

This true example of a powerful multiplex signature involves a 634–probe set signature that can identify patients at high-risk for recurrence and/or high risk for cancer-related death. Additionally, the signature has been shown to perform independently from known prognostic factors.

This work was first reported in ASCO’s Journal of Clinical Oncology in 2011. More recently, in January 2014, The Alliance for Clinical Trials in Oncology announced results of a study performed in conjunction with Almac and Helomics Therapeutics Inc.®, which confirmed that the ColDx assay is a significant, independent predictor of recurrence-free interval (RFI) in stage II colon cancer. This external validation proves that the method is transferable and robust.

This test has now been launched in the US by Helomics Therapeutics Inc.® as GeneFX colon, and will help identify those patients at greatest risk of cancer recurrence, for whom chemotherapy may be a useful option following surgery.

View the Journal of Clinical Oncology publication ‘Development and Independent Validation of a Prognostic Assay for Stage II Colon Cancer Using Formalin-Fixed Paraffin-Embedded Tissue’.


Almac's Biomarker Pipeline

Almac’s Biomarker Pipeline

 


Quality Assurance

Almac Diagnostics is accredited by:

• UKAS to ISO17025 (accreditation number 2740)
• CLIA
• College of American Pathologists (CAP)
• New York State (CLEP Permit)
• Almac also holds individual US State licenses for Florida, California and Pennsylvania

Almac Diagnostics holds ISO13485 certification (SGS) and also complies with GLP, GCP and GCLP.