Diagnostics & Imaging Week

Making a difference in the lives of breast cancer patients has been nearly a lifelong goal for Ron Andrews, president/CEO of Clarient (Aliso Viejo, California), a diagnostic services company.

Growing up in McDonough, a “little town in Georgia,” Andrews was raised by his grandmother who battled breast cancer three times. At age 11, he witnessed her “horrible experience” with chemotherapy, which he says motivated him to pursue different career avenues over the past 25 years, hoping to help improve cancer care.

Perhaps that is why Andrews was so enthusiastic Thursday when he spoke to Diagnostics Imaging Week about Clarient’s plans to commercialize a new breast cancer test – the first molecular test available that is applicable to all stages of operable breast cancer, including lymph node-positive patients, the company said.

Clarient will sell the new test, Clarient Insight Dx Breast Cancer Profile, through an exclusive license agreement with Prediction Sciences (La Jolla, California), a company that develops molecular diagnostics for disease detection, prognosis and selection of appropriate therapy.

A limited market release is planned for Q108, Andrews told D&IW, with a full market release expected sometime in mid-2008.

According to Clarient, Insight Dx is a series of molecular assays that, when combined using Prediction Sciences’ algorithm, offer information designed to help individual patients and their physicians understand the risk of recurrence and assist them in selecting the most appropriate therapy. The profile could allow patients to avoid the toxic effects of unnecessary chemotherapy, thereby reducing the overall cost of care, the company said.

Clarient said the availability of its test is a reflection of the healthcare industry’s move toward personalized medicine that helps physicians understand the unique aspects of a patient’s disease in order to develop more effective treatment plans.

“I’ve sort of become a little more practical about personalized medicine,” Andrew said, adding that his definition of personalized medicine is much simpler than one focusing on gene chips and protein chips. Rather, he says, it is the “understanding that there are variables in each human that allow for different interaction with each treatment.”

Instead of having a hammer – a technology – and looking for a nail to use it on, Andrews said Clarient’s approach identify the problem and find a technology to solve it with.

“Personalized medicine can be actualized without gene chips and protein chips ... [it is] technology that can be applied to really help clinicians to understand how to better adapt treatment plans for the patient,” Andrews said. “This test is really sort of an exclamation point on that.”

The company noted that a large percentage of women who undergo chemotherapy have little chance of benefiting from the toxic treatment. Thus, Clarient said, oncology organizations have recommended adopting this type of test. The potential market for breast cancer tests that identify recurrence risk is estimated to be between $300 million and $400 million a year in the U.S.

“This new agreement provides Clarient with an important addition to our breast cancer menu — a new molecular diagnostic test that we believe predicts the likelihood of disease recurrence, and ultimately the benefit of chemotherapy for patients,” Andrews said. “Along with its significant value for the over 35,000 breast cancer patients we expect to test this year, Clarient’s Insight Dx breast cancer profile has the potential to deliver a significant economic opportunity for the company.”

The new breast cancer profile is the first product in Clarient’s Insight Dx line of molecular tests.

“The Clarient Insight Dx breast cancer profile is the first in a pipeline of tests developed by Prediction Sciences that we believe will significantly improve and personalize patient care,” said Cornelius Diamond, CEO of Prediction Sciences. “We believe that Clarient is well positioned to commercialize this test and provide invaluable benefit to breast cancer patients and their physicians, allowing them to make informed treatment decisions.”

Andrews added that the breast cancer profile is the first of its kind to combine proteomic and genomic markers with tumor morphology data received directly from the patient’s pathologist, thereby allowing a more accurate characterization of the disease.

“This clearly fits our business model of engaging and empowering the community pathologist in the analysis process,” he said.

The new breast cancer profile has undergone rigorous validation, he said. As preparations are made for full market launch this year, Clarient and Prediction Sciences plan to continue to generate clinical data designed to further expand the established indications and to comply with future regulatory requirements.

Andrews said Clarient is launching the product as a lab-developed test; however, he said the company is aware of FDA’s guidance proposal and is prepared to follow it, if adopted.

“Clarient currently performs approximately 20% of all breast cancer prognostic work-ups in the U.S.,” Andrews said. “We are extremely proud of the brand we have developed in such a short period in the area of breast cancer, and the availability of this high-value test could improve patient care and decrease the economic burden on the healthcare system.”

Clarient’s plan to commercialize this new breast cancer profile follows a slew of recent developments in breast cancer treatment.

Many of these developments were reported at last month’s San Antonio Breast Cancer Symposium. Monogram Biosciences (South San Francisco) was among the companies presenting data at the symposium, detailing its HERmark assay’s ability to identify metastatic breast cancer patients who are most likely to respond to the drug Herceptin.

HERmark is a diagnostic designed to quantify HER2 expression and dimerization in patients with breast cancer. According to the company, preliminary data suggest that the test can identify patients who are likely to respond to Herceptin with greater precision than currently available tests.

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