WALTHAM, Mass. – Thermo Fisher Scientific has cleared a major regulatory hurdle in getting a new diagnostic tool for a type of blood cancer in the hands of doctors.
The Massachusetts-based life sciences company, with locations in the Lehigh Valley that include Upper Saucon, East Allen, and Upper Macungie townships, said it has received 510(k) clearance for its EXENT System to be used in the diagnosis of multiple myeloma.
The clearance, granted by the Food and Drug Administration (FDA), means the EXENT System is now available for clinical use in the U.S.
Credit: Thermo Fisher
Thermo Fisher described EXENT as a first-of-its-kind automated platform that is designed to detect abnormal antibodies produced by cancerous plasma cells at low concentrations, which could result in a faster diagnosis for patients.
The company said more than 176,000 people are diagnosed with multiple myeloma worldwide each year. It’s a type of cancer that affects plasma cells in bone marrow.
“Our continued goal is to equip laboratories and clinicians with technologies that deliver greater accuracy, efficiency and clarity, enabling more informed clinical decisions and improving the patient journey,” said Stephen Harding, vice president and general manager, protein diagnostics, Thermo Fisher Scientific, in a news release. “The EXENT System reflects Thermo Fisher’s commitment to advancing diagnostic solutions that meet well-defined clinical needs.”
The EXENT System also is approved for use in other parts of the world, like Canada, Australia, the United Kingdom, the Netherlands and Brazil.
Thermo Fisher calls itself the world leader in serving science, with annual revenue over $40 billion. It’s a global company that makes a wide variety of products, equipment and services for scientific research and clinical diagnostics.