Molecular Diagnostics a Natural Fit for Breast Cancer


Breast cancer is the most common cancer among women worldwide, and the number of new cases is rising. The World Health Organization estimates that 1.38 million new cases were diagnosed in 2008, up from approximately 500,000 in 1975. Developed regions seem to have significantly higher incidences of breast cancer, while the incidence is lower in less developed regions of the world. Although the mortality rate is much lower in developed regions, cancer is still the leading cause of cancer death in women. The WHO projects that 2.1 million new cancer cases will be diagnosed in 2030.


The growing global incidence of breast cancer has led to an increased demand for molecular diagnostics tests that aid in diagnosing breast cancer (the earlier the better), selecting a treatment, and monitoring patients for relapse. Market intelligence firm Research and Markets profiles some of the major players in this space with a new report titled “The Top 30 Developers of Molecular Diagnostic Tests for Breast Cancer.” According to a press release, the report covers well-known developers such as Clarient and Myriad as well as lesser-known companies such as Nuvera Biosciences and DiaGenic ASA. Clarient focuses on comprehensive cancer diagnostic services, including diagnosis of tumor type, cancer sub-typing, patient classification by risk level, therapy selection, and patient monitoring during treatment. Myriad markets predictive medicine tests for a variety of cancers. Nuvera Biosciences, Inc. is focused on developing novel molecular diagnostics that make a significant impact on cancer care by improving detection techniques and treatment selection in cancer. Nuvera’s initial offering is aimed at differentiation and selection of treatments in breast cancer leading to higher response from chemotherapy and endocrine therapy and better rates of survival among treated patients. DiaGenic ASA, named Norway’s Most Innovative Company in 2009, is currently in the process of establishing a distribution network for its breast cancer test, BCtect.


According to a recent Motley Fool article, oncology has become closely linked to molecular diagnostics through the use of “companion diagnostics,” tests that analyze genetic or proteomic information to help determine the likelihood of a patient responding to a particular treatment or experiencing an adverse drug reaction. Companion diagnostics can also help ascertain the proper dosing level. These tests may be developed alongside the drug itself, which could improve the drug’s chances of gaining regulatory approval.


Companion diagnostics can also be developed for drugs that are already on the market. Dako’s recently launched HER2 CISH pharmDx Kit is designed to assess breast cancer patients for whom Herceptin is being considered as a treatment option.


Which companies make up your top 30 developers of molecular diagnostic tests for cancer?  Post your feedback in comments.