Medical Device Daily
Mesothelioma, a form of cancer caused by exposure to asbestos, may not be the most common form of cancer, but it is highly aggressive and therefore any sign of strong recurrence following surgery or indication of a response to therapy could be helpful in patient care.
Toward that end, Fujirebio Diagnostics (Malvern, Pennsylvania), which has promoted its work on the assay for some years now, recently secured FDA approval under the Humanitarian Device Exemption (HDE) program for its Mesomark assay.
The company says it is the first in vitro test for mesothelioma, which requires a blood test to enable physicians to monitor patients diagnosed with biphasic or epithelioid mesothelioma. The test is expected to be available in the U.S. to physicians through a central reference lab beginning this quarter.
"The Mesomark test signifies the beginning of a new era in monitoring mesothelioma malignancies," said W. Jeffrey Allard, vice president and chief scientific officer of Fujirebio. "As the first in vitro test for patients with this aggressive disease, it will enable doctors to more accurately detect recurrence and monitor treatment of patients."
Mesothelioma affects the sac lining the chest, the abdominal cavity or the area around the heart. It is found in many cases in people who have been employed in workplaces where asbestos was present and could be inhaled, such as in the shipbuilding and construction industries.
Fujirebio said that most insulation and construction materials made before the mid-1970s contained asbestos, including insulation on pipes and boilers; roof, floor and ceiling tiles; as well as automobile brakes.
The test is approved for the following uses in those patients confirmed as having mesothelioma: for recurrence following surgery; or for measuring response to therapy. The Mesomark assay test kit was developed to measure levels of a particular biomarker, called mesotheline, in serum.
Mesomark is designed to work by identifying serum tumor markers that are released into the bloodstream by malignant mesothelioma cells.
"Current diagnostic tests are less than ideal for quantification of changes in tumor volume, which is key to managing the disease," said Allard. "As the Mesomark results correlate with tumor volume, it provides a much-needed tool for monitoring patient status."
Allard also said that Fujirebio expects to collect additional data to support the use of the test also to detect mesothelioma, in addition to its current approval for monitoring of the disease. The company first reported that the test was under FDA review in May 2005. At that time, Fujirebio expected a response within six months (Medical Device Daily, May 6, 2005).
Monte Wiltse, VP of sales and marketing for Fujirebio, emphasized the assay's HDE status, and told Medical Device Daily that the "market opportunity for this [test] is actually fairly small."
Wiltse said the "reason why we pushed this thing so much was our involvement with some of the advocacy groups early on."
While Wiltse would say that there will only be one central reference lab exclusively providing the tests, and that the name of that lab will be released later.
"We're going to do all of the promotion of this test through indirect promotions," he said. "It made no sense for us to do this at multiple laboratories, because they wouldn't get enough volume to justify bringing it in."
"At best," he said, there may be 15,000 tests for monitoring the disease completed annually.
"Development of a reliable biomarker is a major advance in the care of mesothelioma," said Chris Hahn, executive director of the Mesothelioma Applied Research Foundation (Meso Foundation; Santa Barbara, California), a national research funding, patient support and advocacy organization for patient with the disease and their relatives.
Another company, Agilent Technologies (Palo Alto, California), reported in April of 2005 that its Human Genome CGH Microarray technology would be used by researchers at the Peter MacCallum Cancer Center (Melbourne, Australia) in a three-year study designed to better understand mesothelioma (MDD, April 25, 2005).
The company said at the time that rates of the disease have tripled in the past 20 years and are expected to peak about 2010 in Australia, where asbestos was mined heavily in the mid-1900s. Agilent also said that Australia has the highest incidence of mesothelioma in the world.