Article

Companion Diagnostics are transforming Cancer Care through Precision Medicine

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Companion Diagnostics (CDx) are a class of diagnostic devices used alongside a specific therapeutic drug to ensure the patient is likely to benefit, with increased effectiveness and reduced risk from side effects.

 

CDx are an essential component in a new wave of cancer treatments known as precision medicine.  These diagnostics have been described as a “GPS” for cancer treatment, enabling specific targeted strikes. In this analogy, they replace prior treatments that were equivalent to crude paper maps, offering limited accuracy and frequently resulting in collateral damage. 

 

Since the first approval 25 years for a drug targeting breast cancer with the HER2 gene, CDx has become a driving force in the next generation of oncology. Precision medicine by definition relies on the ability to measure predictive biomarkers. The evolution of CDx over the past decade has included testing for genes often associated with specific cancers and corresponding therapies.

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Diagnostic manufacturers have also created comprehensive diagnostics that apply to multiple targeted therapies. Firms such as Foundation One and Illumina have created a genomic profiling test capable of detecting mutations in hundreds of genes to identify patients who may benefit from dozens of FDA-approved therapies in different disease categories. Recently diagnostics such as MI Cancer Seek, expand beyond genomics to analyze exome (protein-code DNA) and transcriptome (expressed RNA) biomarkers.

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FDA Guidance for CDx

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The FDA has focused on providing clarity, efficiency and other forms of support for the burgeoning field of oncology CDx.  In 2020, the agency provided guidance on class labeling, which enables a single diagnostic test to be used with multiple drugs in a therapeutic class instead of requiring a separate test for each individual drug. Last year the FDA launched a pilot program focused on oncology drug-diagnostics aimed as providing transparency, data protocol recommendations and minimum performance requirements for laboratory-developed cancer diagnostics.

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The FDA prioritizes the following factors in the review and approval of a new cancer CDx: 

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Analytical validity data: This demonstrates the test's specificity, sensitivity, accuracy and reliability in measuring the biomarker of interest.

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Clinical validity data: This shows that the test can accurately identify patients who are likely to benefit from the corresponding therapeutic product.

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Standardization: FDA approval ensures standardized methodology and results, addressing potential variability in testing across laboratories.

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Intended Use Statements: The FDA carefully reviews and approves specific claims for the diagnostic's intended use based solely on submitted data.

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Postmarket Monitoring: The FDA has a postmarket program that monitors adverse patient outcomes related to approved diagnostics.

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Regulatory Oversight: By approving companion diagnostics, the FDA provides regulatory assurance that the test is standardized and appropriately validated for use with a specific drug.

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Performance Criteria: The FDA sets high standards for companion diagnostics, ensuring they accurately and reliably identify patients most likely to benefit from an FDA-approved therapy.

 

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The Cancer Moonshot Initiative and CDX

The Cancer Moonshot was initiated by the U.S. government in 2016 to accelerate progress in oncological research, aiming to prevent more than 4 million deaths by in the next 20 years and equitably improve the lives of those impacted by the disease.

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The Cancer Moonshot initiative includes several projects where companion diagnostics play a key role:

 

The Cancer Moonshot Biobank: This project collects biospecimens and associated health information from cancer patients across the United States. The biobank performs genetic testing on tumor tissue and returns results to healthcare providers, which can be used for treatment decisions and to better understand how tumor genes affect cancer progression and treatment

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Next-generation throughput assays: The Cancer Moonshot is supporting the shift towards high-throughput assays like next-generation sequencing (NGS) and mass spectrometry proteomics. These technologies allow for simultaneous assessment of multiple biomarkers, requiring less DNA for analysis and providing higher sensitivity to detect rare and novel mutations.

 

The FDA Oncology Center for Excellence: This was formed to increase collaboration among regulatory scientists and reviewers, expediting product development for combination therapies and companion diagnostics used in prevention, screening, diagnosis, and treatment.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

A Case Study in the Future of Precision Medicine

The Landrich Group is currently supporting a landmark clinical trial in the advancement of companion diagnostic and targeted therapies for cancers in the myeloid cells, which play a key role in blood production in the body.

This is a clinical trial by the National Cancer Institute (NCI) that is testing state-of-the-art precision medicine focused on acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS), two aggressive forms of cancer. Subjects enrolled in the trial undergo rapid genetic testing and personalized therapies for these cancers affecting blood and bone marrow cells.

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Questions on clinical trial management and FDA approval of companion diagnostics in the field of oncology? At the Landrich Group, we’re ready to discuss your needs developing new products in this promising field of medical research.

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