The Race to Establish a Cancer Detection “Liquid Biopsy” Market

illustration-of-cancer-cells   Picture Source: Medical News Today

Cancer is big business in the U.S. and globally, increasingly, as the food and water supply gets poisoned. It starts with a tumor, which is an abnormal mass of tissue or neoplasm which is solid or fluid-filled. Whereas benign tumors don’t spread, cancerous or malignant ones do – spreading rapidly by metastisis. cancer-diagnostics-laboratory-neogenomics-april-2014-company-overview-presentation-11-638

Medical News Today profiles different types of tumors, which are made up of specific types of cancer cells:

  • Carcinoma – these tumors are derived from the skin or tissues that line body organs (epithelial cells). Carcinomas can be, for example, of the stomach, prostate, pancreas, lung, liver, colon or breast. Many of the most common tumors are of this type, especially among older patients.
  • Sarcoma – these are tumors that start off in connective tissue, such as cartilage, bones, fat and nerves. They originate in the mesenchymal cells outside the bone marrow. The majority of sarcoma tumors are malignant. They are called after the cell, tissue or structure they arise from, for example fibrosarcoma, liposarcoma, angiosarcoma, chondrosarcoma, and osteosarcoma.
  • Lymphoma/Leukemia – cancer arises from the blood forming (hematopoietic) cells that originate in the marrow and generally mature in the blood or lymph nodes. Leukemia accounts for 30% of childhood cancers. Leukemia is thought to be the only cancer where tumors are not formed.
  • Germ cell tumor – these are tumors that arise from a germ cell, pluripotent cells (cells than can turn into any kind of cell). Germ cell tumors most commonly present in the ovary (dysgerminoma) or testicle (seminoma). The majority of testicular tumors are germ cell ones. Less commonly, germ cell tumors may also appear in the brain, abdomen or chest.
  • Blastoma – tumors derived from embryonic tissue or immature “precursor” cells. These types of tumors are more common in children than adults. Blastoma is often the root word used in longer ones that describe tumors, for example, medulloblastoma and glioblastoma are kinds of brain tumors, retinoblastoma is a tumor in the retina of the eye, osteoblastoma is a type of bone tumor, while a neuroblastoma is a tumor found in children of neural origin.

The evidence of a sharp rise in cancer incidence globally is staggering and documented by the World Health Organization (WHO) in their Global Cancer Observatory here:

fact-sheets-cancersIn 2012, worldwide, there were 14.1 million new cancer cases, 8.2 million cancer deaths, and 32.6 million people living with cancer within 5 years of diagnosis; 57% (8 million) of those new cancer cases, 65% (5.3 million) of the cancer deaths, and 48% (15.6 million) of the 5-year prevalent cancer cases occurred in the less developed regions. In 2014, the WHO’s Cancer Report predicted a 57% rise in cancer incidence over 20 years.

 

 

The National Cancer Institute defines a solid cancer tumor as:

An abnormal mass of tissue that usually does not contain cysts or liquid areas. Solid tumors may be benign (not cancer), or malignant (cancer). Different types of solid tumors are named for the type of cells that form them. Examples of solid tumors are sarcomas, carcinomas, and lymphomas. Leukemias (cancers of the blood) generally do not form solid tumors. Doctors and patients depend on accurate information derived from diagnostic tools, such as clinical laboratory tests, imaging studies, and genomic analysis, to make decisions at all stages of cancer care. Omics tests include those based on such disciplines as genomics, epigenomics, transcriptomics, proteomics, and metabolomics, which is the study of small-molecule metabolites in cells and tissues that are present in bodily fluids, such as blood and urine.

Scientists are aware that fragments of cancer cells that die are detectable in the blood as various cancers (especially breast and prostate) are rapid replicators and many spread from one organ to another in a process called metastasis. In addition, there is substantial research to suggest that cancers have their own stem cells. Another approach taken by Stanford has been to identify tumor DNA in the bloodstream led by Maximilian Diehn, MD, PhD, an assistant professor of radiation oncology and the CRK Faculty Scholar, and his team. The researchers termed their new, two-pronged approach “integrated digital error suppression,” or iDES which involves “bar coding” DNA strands before amplification. IDES builds upon a method called CAPP-Seq that Alizadeh, Diehn and Newman previously devised to capture very small amounts of tumor DNA from the blood by looking for a panel of mutations known to be associated with a particular cancer.

While there are a number of venture capital funded cancer detection firms, there is battle for an emerging cancer screening by bringing a “liquid biopsy” to market.  The promise here is to sharply cut the cost of tissue biopsy, promote earlier cancer detection, and take a less invasive approach to patient care. When the liquid biopsy tests identified key genes known to drive cancer growth, such as BRAF, KRAS, EGFR, ALK, RET and ROS1, those same mutations were also present in 94 percent to 100 percent of the tissue samples from these same patients. The leading horse in this battle is the genomics equipment supplier Illumina, which has decided to “spin out” Grail – a subsidiary it controls but has new investors including (Jeff) Bezos Expeditions, Bill Gates, Sutter Hill Ventures and Arch Capital Partners. GRAIL CEO Jay Flatley explained in GEN, “GRAIL’s promise is to revolutionize screening across all cancer types, using the sensitivity and specificity of next-generation sequencing to create a molecular stethoscope that measures the ultimate cancer biomarker. ”The more sensitive the test, Flatley said, the larger the potential market for it. That market, he said, could be as large as $20 billion to $40 billion if ctDNA could detect stage 2 across a broad range of cancers—but could grow to more than $100 billion if the tests can detect stage 1 as well as determine tissue of origin. Illumina is aiming to provide a $1000 genome sequencing for patients in 2017 when large scale ctDNA trials are expected to be launched. Three other dark horses to watch are ITUS, Guardant Health  and Pathway Genomics.

 

 

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