Mesothelioma news | Breaking mesothelioma news | Mesothelioma

CISBIO Announces FDA Approval of MESOMARK

...The MESOMARK test is developed and manufactured by Fujirebio Diagnostics, Inc.

of Malvern, PA; CISBIO is the exclusive distributor of MESOMARK in Europe, where it is currently undergoing evaluation for clinical use.

The MESOMARK test is now accessible to physicians across the U.S.

for monitoring patients who have been diagnosed with epithelioid or biphasic This minimally-invasive tool requires only a blood sample.

The transition of the MESOMARK test from research to clinical usage will be significant in managing An estimated 10.000 new cases are diagnosed in industrialized countries each year.

Although recent progress has been made in chemotherapy and surgical techniques for treatment, diagnosing and monitoring remain difficult.

Current testing methods used to determine patient treatment can be invasive and costly.

The MESOMARK Assay is a manual enzyme-linked immunosorbent assay (ELISA) that identifies a group of molecular markers called soluble mesothelin-related proteins (SMRP).

Released into the bloodstream by The approval was given under the FDA’s Humanitarian Device Exemption (HDE) program, which authorizes companies to market medical devices to treat or diagnose diseases which meet certa...

Read more...

1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | 15 | 16 | 17 | 18 | 19 | 20 | 21 | 22 | 23 | 24 | 25 | 26 | 27 | 28 | 29 | 30 | 31 | 32 | 33 | 34 | 35 | 36 | 37 | 38 | 39 | 40 | 41 | 42 | 43 | 44 | 45 | 46 | 47 | 48 | 49 | 50 | 51 | 52 | 53 | 54 | 55 | 56 | 57 | 58 | 59 | 60 | 61 | 62 | 63 | 64 | 65 | 66 | 67 | 68 | 69 | 70 | 71 | 72 | 73 | 74 | 75 | 76 | 77 | 78 | 79 | 80 | 81 | 82 | 83 | 84 | 85 | 86 | 87 | 88 | 89 | 90 | 91 | 92 | 93 | 94 | 95 | 96 | 97 | 98 | 99 | All news