Fujirebio Diagnostics (FDI; Malvern, Pennsylvania) has submitted a 510(k) application to the FDA for clearance of Mesomark, the first blood test for mesothelioma, a cancer caused by asbestos exposure that occurs in the lining of the body’s organs, or mesothelium, usually in the chest cavity.

Mesomark, a manual enzyme-linked immunosorbent assay (ELISA) is designed to work by identifying serum tumor markers called soluble mesothelin-related peptides (SMRP), the company said. Those peptides are released into the bloodstream by malignant mesothelioma cells.

FDI’s mesothelioma assay is a two-step immunoassay that quantitates SMRP in human blood using a standard ELISA microplate sandwich assay format.

Jeff Allard, chief scientific officer and vice president, told Medical Device Daily that he expects that it will take the FDA up to six months to respond to the application.

“We are pleased to bring this new and exciting diagnostic tool for monitoring mesothelioma before the FDA for review,” said Paul Touhey, president and chief operating officer of FDI.

“Mesomark further demonstrates FDI’s commitment to deliver . . . non-invasive technologies that help patients and physicians better manage cancer.”

Fujirebio said that “up until now, there have been no reliable serum tumor markers” for mesothelioma, making diagnosis, screening and monitoring responses to treatment difficult for a type of cancer that it said is “notoriously resistant to chemotherapy and radiotherapy” and which is “rarely cured by radical surgery.”

Fujirebio conducted clinical trials beginning late last year. That trial found that 20 of 31 patients in the trial had Mesomark concentrations greater than 2.0 nM while in the study. All 20 patients experienced recurrence of mesothelioma, and the mean lead time for detection of recurrence by Mesomark was 16 weeks.

As a comparison, Mesomark was elevated above 2.0 nM in only one out of 409 healthy subjects studied as a control group. There was also a level of 77% agreement between changes in the Mesomark concentrations compared with changes in clinical status of the study subjects, which was defined as recurrence or no recurrence of mesothelioma.

Allard told MDD that FDI’s 510(k) application specifically requests that the Mesomark test at this time be used to determine recurrence of mesothelioma. Allard said the Mesomark test would come with the recommendation that patients who have had mesothelioma be tested with Mesomark on a monthly basis.

The company plans to later have the test serve for initial detection, although Allard said the company has no specific timeframe for this. However, other clinical trials are planned, including one outside the U.S.

Fujirebio first told MDD of its plans to submit an application to the FDA for Mesomark at the annual meeting of the American Association for Clinical Chemistry (Washington) in Los Angeles last July (Medical Device Daily, Aug. 11, 2004).

At that time, Matthew Tumasz, senior director of marketing, sales and business development at FDI, said the company expected to have the test on the market in late 2005, if all went well.

Malignant pleural mesothelioma is a “highly aggressive” form of cancer found in the lining of the chest, the abdominal cavity and around the heart. Fluid accumulates between the lining of the lungs and chest cavity. This type of cancer is caused by work-related asbestos exposure and has an average latency period of 30 to 40 years, according to the company.

More than 100 million people worldwide have been exposed to asbestos through their work in the past five decades. Rates of mesothelioma have tripled in the last 20 years, and 10,000 new cases are diagnosed each year in the industrialized nations. Recent epidemiological studies predict an increase in that number in the next few decades.

However, in the U.S., Allard said the test could be considered to have an “orphan” status, as with certain drugs, because only 2,000 to 3,000 people are diagnosed in the U.S. with the disease each year.

According to Agilent Technologies (Palo Alto, California), Australia has the highest incidence of mesothelioma in the world, due to that country’s active mining and manufacturing of asbestos in the mid-1900s (MDD, April 15, 2005).

Agilent’s Human Genome CGH Microarray technology will be used by researchers at the Peter MacCallum Cancer Center (Melbourne, Australia) in a three-year study designed to better understand mesothelioma. Rates of the disease are expected to peak about 2010, it said.