Navigation Links
Report: Beyond OncoTypeDX, Tests "Sold as a Service" Prosper

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.
  • LabCorp
  • MDxHealth SA
  • MedGenome Labs Private Ltd. (India)
  • Myriad Genetics, Inc.
  • Myriad RBM, Inc.
  • Novigenix
  • 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, 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 and

We routinely assist the media with healthcare topics. Follow us on Twitter, LinkedIn and our blog at  

Bruce Carlson
(212) 807-2622

Logo -


SOURCE Kalorama Information
Copyright©2015 PR Newswire.
All rights reserved

Related biology news :

1. Report: Glucose Monitoring Market tops $10 Billion
2. Kalorama Report: Sizable Number of Acquisitions and Joint Ventures in Molecular Diagnostics
3. UN climate report: Pricing of CO2 emissions critical
4. Report: Climate change to shift Kenyas breadbaskets
5. DNA Microarray 2013 Market Report: A Focus on Sales Growth
6. NAMS issues first comprehensive recommendations on care of women at menopause and beyond
7. To clean air and beyond: Catching greenhouse gases with advanced membranes
8. NYSCF partners with Beyond Batten Disease Foundation to fight juvenile Batten disease
9. Report on viruses looks beyond disease
10. Genetics of sex -- beyond just birds and bees
11. Going beyond the surface
Post Your Comments:
(Date:7/1/2020)... (PRWEB) , ... July 01, 2020 , ... ... that it had completed the purchase of Teva-Takeda Pharmaceuticals’ packaging facility in Minakuchi, ... company’s existing Japanese clinical supply facility located in Kakegawa, the new 60,000-square-foot facility ...
(Date:6/28/2020)... , ... June 25, 2020 , ... In an upcoming ... innovations in accelerated Point of Care Testing solutions (POCT). Check local listings for more ... collected at medical offices and are shipped to labs throughout the country. Results are ...
(Date:6/23/2020)... (PRWEB) , ... June 23, 2020 , ... ... supporting sustainable healthcare, and Renovagen Ltd, a UK supplier and manufacturer of innovative ... to support testing operations in the fight against the COVID-19 pandemic in Zambia. ...
Breaking Biology News(10 mins):
(Date:8/15/2020)... ... August 13, 2020 , ... True Terpenes , the ... its Scientific Advisory Board (SAB) to research the medical potential of terpenes and the ... when combined with terpenes. The board is focused on expanding the recently launched line ...
(Date:8/12/2020)... FARMS, Mich. (PRWEB) , ... August 12, 2020 ... ... Consulting Group, Inc. (EMMA International), a global leader in FDA compliance consulting ... of the nation’s fastest-growing private companies. The list represents a unique look at ...
(Date:7/31/2020)... ... 29, 2020 , ... R3 Stem Cell International is now offering patients the ... stem cells total, patients may choose which extremities they would like treated. , Several ... Musculoskelet Disord. 2016). At R3 International, umbilical cord tissue is obtained from a lab ...
(Date:7/31/2020)... ... July 29, 2020 , ... Editas ... global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, ... entered into a strategic partnership whereby Catalent will provide support for the development, ...
Breaking Biology Technology: