Clarient: New Breast-Cancer Test

For women who survive breast cancer, the triumph of beating the odds is often tempered by a fear of the cancer returning. A study published last year in the Journal of the National Cancer Institute looked at 3,000 breast cancer patients, and found that the group averaged an 11 percent chance of recurrence five years after undergoing adjuvant therapy (such as chemotherapy). That figure was slightly lower for early-stage patients, and slightly higher for stage III patients. After 10 years, the overall group’s risk increased to 20 percent.

A new test promises to help early-stage breast cancer patients determine their risk of recurrence. Clarient (CLRT), a provider of comprehensive anatomic pathology and molecular testing services, is launching a new breast cancer test that helps physicians calculate the probability of a patient’s cancer returning. The test, called the Clarient Insight Dx Breast Cancer Profile, has been clinically validated for women with early-stage, hormone-receptor positive breast cancer. These patients face the critical decision of whether or not to undergo chemotherapy. Knowing their odds of recurrence can assist them in the decision-making process.

The test is unique in that it examines both molecular markers and pathology staging risk factors. Staging risk factors are tumor size, tumor grade, and lymph node involvement. The test looks for seven different molecular markers, including ER, PR, and HER2. The data is plugged into a proprietary algorithm to generate a risk score that aids in clinical decision-making. Patients are classified as “Low Risk” or “High Risk” based upon the results. A study found that after 10 years, the low-risk group had only a 3 percent recurrence of breast cancer 10 years after surgery, while the high-risk group had a 62 percent recurrence.

Clarient was also recently granted exclusive rights to commercialize the breast cancer biomarker FOXA1 by the Indiana University Research and Technology Corporation. FOXA1, which is known to cause breast cancer, will be used to complement the Insight Dx Breast Cancer Profile.

Related video: Ron A. Andrews, CEO of Clarient

Comments

[ggrail:]

Clarient's licensing of the FOXA1 marker appears to be a direct shot across GHDX's bow and may point out some of the fragility of a company that has focused so much of its expenditure and efforts on a single diagnostic regimen with their very good OncotypeDx diagnostic.

The foundations laid by Genomic Health to obtain FDA approval and the costs associated with that Herculean effort paid off initially for them. Now that we are entering a new phase in the maturity of the genomic marker/diagnostics space it may be that the spoils go to the nimble.

The rapid discovery of new markers and the matching of those markers with potential treatment options for cancer and other disease have led to a dizzying palette of choices for pathologists, oncologists and clinicians, not to mention patients.

Clarient's ability to seize the moment and make sound business decisions based on being on being aware of what the latest discoveries have to offer and then most importantly putting their alchemists caps on and creating effective homebrew diagnostics that are applied to the treatment of cancer is an important bridge between treatment and discovery. The ability to absorb and react to change will be the new mantra for success in this space.

Not many companies are so positioned as most of the larger independents have been assimilated by the larger pharmas and biotechs. The future for Clarient will be played out on an ever changing regulatory field so it is not without risk. But the rewards for what CEO Andrews terms as being "technology agnostic" may be great

May 06 09:57 AM