Breakthroughs in Biomarkers for Oncology

Prognostic biomarkers are used to identify patients with different clinical outcomes associated with various forms of cancer. Frost & Sullivan believes the following technologies and companies will have a significant impact on how the field of oncology tests for and diagnoses cancer.

Predictive and prognostic biomarkers constitute a central element of targeted oncology drug discovery and development programs. Predictive programs provide the clinical community the opportunity to offer individualized therapies and health programs. Prognostic biomarkers are used to identify patients with different clinical outcomes associated with various forms of cancer. Frost & Sullivan believes the following technologies and companies will have a significant impact on how the field of oncology tests for and diagnoses cancer.

Proteomic Markers Expected to Transform the Future of Precision Oncology

Alterations in cancer cell protein expression are often detected using two-dimensional gel electrophoresis techniques. However, the advent of microarray, mass spectrometry and multiplexed protein assay platforms has enabled comprehensive, large-scale proteomic studies. These technical advances have also facilitated the development of enhanced diagnosis and management techniques for several cancer indications. While immunoassay techniques such as immunohistochemistry continue to be a key diagnostic method, especially in cancer immunotherapy settings, there are emerging technologies in this space. These include advanced mass spectrometric (MS) platforms, such as matrix-assisted laser desorption/ionization, time-of-flight MS, liquid chromatography-MS and protein microarray technologies for multianalyte quantitation.

The predominant cancer application for proteomic markers is their use in companion diagnostic settings to select an appropriate cancer immunotherapy. Proteomic markers are also likely to play a growing role in cancer monitoring applications. Antibody microarrays that measure multiple protein markers in biofluid samples, such as blood, serum, plasma or urine, may be useful for cancer prognosis in the near future. Proteomic biomarker analysis may also play a significant role in target-based medicine discovery and may aid the development of novel cancer therapies.

Proteomic Markers for Precision Oncology Applications

San Diego-based Applied Proteomics offers a unique blood test, the SimpliPro Colon, which identifies patients with a high risk of colon cancer. Although the test is not intended to replace colonoscopies, it is a unique platform that uses mass spectrometry to evaluate a proteomic marker panel and identify individuals at a higher risk of colorectal cancer. Applied Proteomics is also developing the SimpliPro Colon-A platform, which will evaluate the risk of colorectal cancer using a finger prick or blood-on-card sample.

Leica Biosystems (a subsidiary of German-based Danaher) offers the U.S. Food and Drug Administration-approved Bond Oracle HER2 IHC System for human epidermal growth factor receptor 2 detection in breast cancer tissues, and it enables the selection of Herceptin (trastuzumab) therapy. The company also produces definitive antibody reagents for the detection of multiple protein biomarkers in breast cancer. The highly definitive antibodies for breast cancer immunohistochemistry (IHC) applications are targeted against protein markers such as progesterone receptor; estrogen receptor; E-cadherin; cytokeratins 5, 7, 14 and 20; and p53 protein. Companion diagnostic tools are poised to have a larger impact across precision oncology settings.

Precision Oncology Likely to be an Important Emerging Trend

Foundation Medicine Inc. of Cambridge, Mass., offers a comprehensive range of genomic tests that provide valuable molecular insights in cancer patients. These assays are likely to be used for the selection of ideal immunotherapies, targeted treatment strategies and clinical trial studies. The company’s diagnostic portfolio includes FoundationOne, FoundationOneHeme, FoundationACT and FoundationFocus CDx BRCA. These assays use blood, formalin-fixed paraffin-embedded tissue and bone marrow aspirates as sample types to evaluate genomic markers relevant to melanomas, leukemia, and lung, ovarian and other cancers. The technology platform is in line with precision medicine in oncology and could transform the emerging personalized therapy landscape.

MDxHealth, a global diagnostic company with offices in the United States, Belgium, and Netherlands, offers innovative molecular technologies for the diagnosis and management of bladder and prostate cancers. The company’s flagship technology, methylation specific polymerase chain reaction (MSP), offers platform-independent quantitation of methylated genes specific to cancer. The technology has high sensitivity, and approximately 1 cancer cell among 1,000 normal cells can be detected using this technique. The assay can be performed across several polymerase chain reaction (PCR) platforms using tissue or body fluid samples. Because the MSP technology can also be used across liquid samples, such as urine, it offers a noninvasive alternative to tissue biopsies. MSP technology also offers high-throughput testing of methylated genes, which are specific to different cancer types.

Nucleic Acid Biomarkers Likely to Dominate Screening and Predictive Applications in Clinical Oncology

Rapid technological advances have fueled the growth of several DNA and RNA sequencing platforms that help identify DNA mutations and transcriptomic defects that cause several pathological conditions and lead to cancer. Plummeting sequencing costs have empowered next-generation sequencing platforms to enable comprehensive nucleic acid sequencing. The epigenetic analysis of DNA methylations using PCR-based methods also is an emerging technological trend for the discovery of novel cancer biomarkers. The advent of microarray, microfluidic and multiplex biomarker platforms is likely to increase the role of nucleic acid biomarkers in cancer screening, diagnosis, and management.

Color Genomics of Burlingame, Calif., offers hereditary cancer risk tests using genomic and transcriptomic molecular markers across several indications, which also help select appropriate therapies. Color’s Hereditary Cancer Test analyzes 30 genes, including breast cancer 1 (BRCA1) and BRCA2, to check for mutations. Although mutations in the tested genes are uncommon, their presence can significantly increase the chances of developing cancer.

Emerging Metabolomic Profiling Assays May Facilitate Enhanced Cancer Diagnosis and Prognosis

Advanced technologies such as nuclear magnetic resonance, gas chromatography-mass spectrometry, and liquid chromatography-mass spectrometry are increasingly being used to profile metabolomic markers with biological samples such as tissue, stool, blood, plasma, serum and urine. Metabolic biomarkers such as 2-hydroxyglutarate, fatty acid metabolites, bile acids and amino acids have been associated with several types of cancer. However, the consistency and reproducibility of metabolic panel assays and metabolomic profiling signatures is a major concern. Further research and development in this space may overcome the current challenges across metabolomic screening techniques, which may lead to the higher adoption of metabolic assays across clinical settings in cancer care.

High-throughput metabolomic profiling techniques are suited for cancer diagnosis and prognosis because the sensitivity and specificity of assays usually surpass 80%. For example, metabolomic profiling can help with the early diagnosis of pancreatic cancer, thus addressing late-stage treatment challenges. As methods in metabolomics garner more research and clinical attention, the assays are likely to emerge as new product or service offerings for a wide range of clinical applications in cancer. Several companies are looking to leverage metabolite profiling platforms to develop novel diagnostic and prognostic tools. Metabolite profiling may also be useful for treatment monitoring applications in the near future, while also facilitating novel drug discovery and development.

Redefining Oncology Diagnostics through Comprehensive Biomarkers Assays

Provista Diagnostics is an emerging diagnostic company that offers the Videssa Breast platform. This test is a multi-biomarker enzyme-linked immunosorbent assay that measures serum protein biomarkers and tumor-associated autoantibodies (TAABs) using the company’s unique ProteoMark technology. The technology is used to develop protein signatures using a combination of angiogenesis, inflammatory and cell growth protein markers, in addition to TAAB expression, to help determine the presence or absence of malignancy using blood or serum samples. The technology can help evaluate cancer progression for patients in real time. The Scottsdale, Ariz., company is also looking to develop tests for endometrial, ovarian and HPV-associated cancers. This sensitive and specific technology platform is likely to have a significant industry impact because it does more than assist with early cancer treatment.

NantOmics of Rockville, Md., offers comprehensive cancer biomarker testing services that combine genomics, transcriptomic and proteomic profiling of a wide range of biomarkers. The company’s GPS Cancer test service is conducted in CAP-accredited and CLIA-certified labs and helps clinicians develop comprehensive insights into a cancer patient’s molecular profile. This helps guide important personalized diagnostic and treatment decisions. The GPS Cancer platform consists of more than 20,000 genes and 200,000 RNA transcript sequences in addition to quantitative mass spectrometry analysis of a wide range of protein markers. The high sensitivity of the company’s cancer assay platform can detect attomoles of markers present in micrograms of cancer tissues. The GPS Cancer report is available within 21 days of the test through a cloud-based browser.

The Road Ahead

The growing focus on targeted cancer therapy across research, clinical, regulatory and patient settings is likely to fuel demand for the discovery and development of new proteomic biomarkers. As proteomic biomarkers garner increased attention in companion diagnostic platforms, diagnostic and pharmaceutical companies will continue to work closely in order to fuel groundbreaking innovations in cancer diagnosis and management.

Frost & Sullivan believes that these collaborations, along with more regulatory recommendations for companion cancer diagnostic platforms, will further industry transformation toward the use of genomic and transcriptomic biomarkers for cancer diagnosis and management. Emerging liquid biopsy platforms will increase the use of non-invasive and minimally invasive cancer screening techniques and treatment monitoring applications.

Copyright © 2018 Frost & Sullivan