Medical Device Daily Senior
Molecular diagnostics company Clarient (Aliso Viejo, California) reported the commercial launch of Insight Dx Mammostrat, a new test designed to help quantify the likelihood of recurrence of breast cancer following surgery and initial treatment.
According to the company, the Mammostrat test employs an optimal set of five biomarkers that are able to be identified visually on a patient's tumor specimen by using a well-established technology called immunohistochemistry. Those biomarkers are then analyzed using a mathematical algorithm to generate an assessment of risk for cancer recurrence, Clarient said.
“It takes information from large-scale gene expression experiments and translates it . . . allows you to make sure that what you are testing is in fact the tumor as opposed to assays where you grind up the tumor,“ Rob Seitz, Senior VP of technology assessment at Clarient and one of the developers of the test told Medical Device Daily. In those other tests he mentioned, it can be difficult to know for sure if the test sample is the tumor or healthy tissue, he explained.
Seitz said the Mammostrat test also allows local pathologists to be able to view the images as well.
The company was awarded U.S. patent protection for the test earlier this year (Medical Device Daily, Aug. 11, 2010), just a couple months before GE Healthcare (Chalfont, UK) said it had agreed to acquire Clarient in a deal valued at $580 million (MDD, Oct. 25, 2010). That deal is expected to close late this year or early in 2011.
Mammostrat development was targeted to breast tumors which express estrogen receptor, the most commonly seen subtype of breast cancer, representing about 75% of the women diagnosed each year. The standard of care for most of these patients is surgery to remove the tumor, followed by anti-hormonal therapy. Mammostrat testing will help pathologists, oncologists and patients decide whether additional aggressive chemotherapy should be added to a patient's treatment regimen, the company said.
Mammostrat is well-validated, having been clinically studied on more than 3,000 women, as reported in multiple peer-reviewed journals, including Breast Cancer Research (Volume 12, 2010), Clinical Cancer Research (Volume 14, October 2006), and the Journal of Clinical Oncology (Volume 24, July 2008), Clarient noted. Data from Mammostrat trials have also been presented at national conferences, including the American Society of Clinical Oncology (Alexandria, Virginia) meeting in Chicago and the San Antonio Breast Cancer Symposium.
Clarient says that by using the Mammostrat test pathologists, oncologists and patients can gain greater understanding of the aggressiveness of a patient's disease and guide clinical management. Mammostrat provides additional clinical information that cannot be obtained from routinely used prognostic factors. The Mammostrat test can be performed on small biopsy samples, and results are typically delivered in as little as 48-72 hours, thereby allowing more rapid treatment decisions.
“Mammostrat can be an important tool for clinicians assessing the aggressiveness of their patient's breast cancer,“ said Ron Andrews, CEO and vice chairman of Clarient. “Mammostrat results can provide clinicians important information to help select the appropriate therapeutic management for each individual patient. For patients, Mammostrat offers the confidence that the decisions being made to manage their breast cancer are based on the clinical characteristics of their specific disease using the most current validated technology available.“
Clarient says it is in coverage determination discussions with both government and private insurance carriers.
“Mammostrat fits well within the combined Clarient goals of bringing value to both the patient and to the healthcare system,“ Andrews said. “The test provides validated information more rapidly than other tests currently available, which may allow for treatment to begin earlier in the course of the disease.“
Clarient's customers are connected to its Internet-based portal, PATHSiTE, that delivers high resolution images and critical interpretive reports based on our diagnostic testing. Clarient also develops new “companion“ diagnostic markers for therapeutics in breast, prostate, lung, ovarian, and colon cancers, and leukemia/lymphoma.
When MDD spoke with GE representatives in October after the company agreed to acquire Clarient, there was no doubt about their level of excitement regarding the deal.
“The reason we all are very excited is because we really believe it marks a major step towards cancer treatment,“ Pascale Witz, president/CEO of medical diagnostics at GE, told MDD in October. She said the combination of Clarient's technologies with GE's diagnostic imaging strengths will give the company the ability to develop precision diagnostics – more elaborate and sophisticated diagnostic tests – to enable doctors to make more confident decisions about cancer diagnosis and treatment.
GE said Clarient's technologies, combined with its strengths in diagnostic imaging, are expected to accelerate the development of new integrated tools for the diagnosis and characterization of cancer.
“The pharmaceutical companies are developing more and more pharmaceutical solutions but they require precision diagnostics,“ Witz said. Integrating Clarient's technologies with GE's will allow the company to develop such tests, so that oncologists can adjust the therapy to the patients, she said.
Amanda Pedersen, 309-351-7774;