NEW YORK, Oct. 15, 2015 /PRNewswire/ -- For IVD tests that are too complex to ship to laboratory customers, many diagnostic companies have decided to perform these tests in their own certified laboratory, according to Kalorama Information. Once there were only a few pioneers using this "sold as a service" tactic but the healthcare market researcher said that the tactic is far more common now. The healthcare market researcher notes over 30 companies that have lab tests they perform in their laboratories in its report, The World Market for Cancer Diagnostics, 6th Edition.
"The battle against cancer elites on no single text but usually a combination of technologies, and increasingly novel genetic tests," said Bruce Carlson, Publisher of Kalorama Information. "While a number of cancer diagnostics have been approved by the FDA or are CEmarked, many additional tests are currently available as research use only, and a large number of tests are only available as laboratory developed tests – tests offered as a service by clinical laboratories."
Several molecular diagnostic companies have developed assays to detect gene expression patterns, or genetic signatures associated with a patient's tumor. These signatures can be used to predict things such as risk of recurrence of the cancer following surgery, prognosis, or whether a patient is likely to respond to a particular treatment. These assays measure expression of many different genes, and therefore are very complex compared to PCR assays for single biomarkers. It may not be easy to put the reagents for these tests into a kit for shipment to clinical laboratories. In addition, developing a laboratory developed test (LDT) has historically been a faster route to market, although the regulatory environment for LDTs is changing. As a result of these and other factors, in the traditional in vitro diagnostics (IVD) market, diagnostic companies (manufacturers) develop, manufacture, and market diagnostic tests that are sold to and used by clinical laboratories. In the U.S., these tests are regulated by the FDA. This is the model that is being followed by a large segment of the cancer diagnostics market today. However, for cancer diagnostics, there have been exceptions to this model all along. For example, histology laboratories purchase stains, and often purchase antibodies and/or probes that are then used for immunohistochemistry or in situ hybridization tests that are developed and validated by the clinical laboratory.
An early and very successful company to offer this type of service was Genomic Health with its OncoType DX assays. For 2014, Genomic Health reported $275.7 million in revenues, all of which was product revenue generated by performing tests in the company's CLIA laboratory. Genomic Health, Inc. was founded in 2000 and is focused on development and commercialization of genomic-based clinical laboratory services to improve the quality of cancer treatment. These services are provided by the company's CLIA-certified laboratory. The tests use tissue (tumor) specimens. The company's lead product is the Oncotype DX Breast Cancer Test, which is a 21 gene assay that provides clinical experience information for newly diagnosed patients with node-negative or node-positive, ER-positive, HER2-negative invasive breast cancer. Another company that has successfully followed this strategy is Myriad Genetics.
Most of these other companies are private, and their revenues appear to be much less than Myriad Genetics' or Genomic Health's revenues today. However, this is a rapidly growing market. Examples of companies that are developing and/or offering cancer diagnostic tests as laboratory developed tests are shown below. The following are among the companies have cancer tests on the market sold as a service:
- 20/20 GeneSystems, Inc.
- Adaptive Biotechnologies Corporation
- Admera Health
- Biocept, Inc.
- Biodesix, Inc.
- bioTheranostics, Inc.
- Caris Life Sciences
- Castle Biosciences, Inc.
- City of Hope Molecular Diagnostic Lab
- Clarient Diagnostic Services
- Genomic Health, Inc.
- Genoptix (A Novartis Company)
- Guardant Health, Inc.
- MDxHealth SA
- MedGenome Labs Private Ltd. (India)
- Myriad Genetics, Inc.
- Myriad RBM, Inc.
- Pathway Genomics Corporation
- Quest Diagnostics Inc.
- Resolution Bioscience
- Response Genetics, Inc.
- TrovaGene, Inc.
- Veracyte, Inc.
Kalorama's report, The World Market for Cancer Diagnostics lists all significant financing events in cancer testing going back to 2006. The report also provides substantial coverage of companies participating in the market, profiling over 200 competitors. Market size estimates for every segment of cancer testing are also provided. The report is available at
About Kalorama Information
Kalorama Information, a division of MarketResearch.com, supplies the latest in independent medical market research in diagnostics, biotech, pharmaceuticals, medical devices and healthcare; as well as a full range of custom research services. Reports can be purchased through Kalorama's website and are also available on www.marketresearch.com and www.profound.com.
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SOURCE Kalorama Information