Clarient Inc announced the commercial launch of a new breast cancer test that helps physicians identify the probability of a patient’s cancer recurring and assess the need for chemotherapy.
The new prognostic test, Clarient Insight® Dx Breast Cancer Profile, has been clinically validated for women with early-stage, hormone-receptor-positive breast cancer. Unlike other assays used to determine the likelihood of recurrence, the Clarient Insight Dx Breast Cancer Profile uses a combination of pathology risk factors and molecular markers to categorize patients as either high or low risk.
In 2008, approximately 205,000 people in the United States and 1.3 million people worldwide were diagnosed with breast cancer. Many of these patients are diagnosed as early-stage, hormone-receptor positive breast cancer patients who are faced with the critical decision of whether or not to undergo chemotherapy.
"If you have breast cancer, you want to know if your cancer will recur, and if chemotherapy is the right treatment for you," says Ken Bloom, MD, Chief Medical Officer for Clarient.
"Our laboratory-developed test helps pathologists, oncologists and patients make better informed, more personalized treatment decisions. We believe that pathologists are uniquely trained to understand the complex puzzle of testing that makes up the diagnosis and prognosis of cancer. Delivering a panel of well-characterized and well-published markers combined with traditional clinicopathological information to our network of pathologists will take some of the mystery out of the decisions oncologists and their patients have to make."
The Clarient Insight Dx Breast Cancer Profile combines three traditional pathology staging risk factors with seven key molecular markers. Staging factors are tumor size, tumor grade, and lymph node status. Molecular markers include ER, PR, HER2, EGFR, BCL2, p53, and MYC. The information is then combined with a proprietary algorithm to produce a risk score that assists pathologists and oncologists in clinical decision-making.
"With the launch of the Clarient Insight Dx Breast Cancer Profile, we move one step closer to fulfilling our vision of transforming breast cancer from a deadly disease to a chronic disorder," says Ron Andrews, CEO of Clarient.
"Despite other offerings in the marketplace, there is a huge unmet need for women with this type of cancer. At Clarient, we currently perform a range of prognostic testing such as ER, PR and HER2, and we also have a deep menu of molecular pathway tests that enable pathologists to ascertain a thorough understanding of each individual tumor. The ability to now further test these patients for risk of recurrence strengthens our service offering to our pathology clients, as well as enhances our overall competitive position in the breast cancer testing market."
Clarient conducted an independent study using a set of breast cancer patients from the Royal Perth Hospital in Western Australia to clinically validate the Clarient Insight Dx Breast Cancer Profile. The algorithm demonstrated an accurate, actionable risk recurrence score. In the study, high- and low-risk patients were identified using the Clarient Insight Dx Breast Cancer Profile.
The low-risk group had only a 3 percent recurrence rate 10 years after surgery. This is equivalent to a negative predictive value of about 97 percent, and the corresponding positive predictive value was 39 percent.
In studies completed to date, Clarient’s test also outperformed the commonly used and well-regarded Adjuvant! Online cancer treatment assessment tool, accurately identifying about 25 percent more low-risk patients.
Clarient’s results also correlated with the earlier validation findings of Prediction Sciences, the exclusive licensor of Clarient Insight Dx Breast Cancer Profile. Prediction Sciences studied the profile’s performance in several independent trials, and presented its findings in the International Journal of Cancer in February 2009 and at the San Antonio Breast Cancer Symposium in December 2008. In the development of this profile, more than 1,000 patient results have now been analyzed.
"Our initial marketing efforts will be focused on educating our network of community pathologists on the value of this additional information to clinicians and their patients," commented Andrews. "Our full marketing efforts will now commence, and while we expect that it will take some time for additional papers and publications to unfold, we believe we will begin to see revenue traction for the new test by fall of this year.
Additional information on the Clarient Insight Dx Breast Cancer Profile and the data produced during the clinical validation testing is available on the company’s [removed]Web site[/removed].