Thermo Fisher Scientific Announces Extended 510k Clearance of Freelite Assays for Evaluation of MGUS, a Precursor to Multiple Myeloma
29 Julio 2024 - 7:30AM
Business Wire
Thermo Fisher Scientific Inc., the world leader in serving
science, today announced it has been 510k cleared, following US
Food and Drug Administration (FDA) requirements, to market its
Optilite® Freelite® assays’ claim for the evaluation of monoclonal
gammopathy of undetermined significance (MGUS).
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Alongside other laboratory tests,
Freelite assays are used as part of a workflow for diagnosing and
monitoring monoclonal gammopathies. (Photo: Business Wire)
MGUS affects an estimated 3% of the U.S. population over 50 and
is a lifelong condition where abnormal monoclonal proteins are
found in a patient’s blood.1 Once identified, it is important to
continually evaluate the monoclonal protein, including serum free
light chain serum concentrations as, rarely, the disorder
progresses to Multiple Myeloma and other monoclonal gammopathies
such as light chain amyloidosis or lymphoproliferative disorders
such as Waldenstr�m's macroglobulinemia.2
Alongside other laboratory tests, Freelite assays are used as
part of a workflow for diagnosing and monitoring monoclonal
gammopathies. The assays provide healthcare professionals with a
highly sensitive and accurate way to measure kappa and lambda free
light chains (FLC) in serum, enabling the identification of even
small concentrations of monoclonal FLC proteins in patients
undetectable by serum protein electrophoresis.
“Our easy-to-use Freelite assays are trusted by healthcare
professionals globally, and with the new claim, and as a key part
of laboratory diagnostics tools, we can help healthcare providers
continually evaluate patients with MGUS, which is important to
understand the disorder and the progression to pathological
malignancies,” said Hamid Erfanian, Vice President and General
Manager, Protein Diagnostics, Thermo Fisher Scientific. “Earlier
identification of MGUS will enable more effective monitoring of
disease progression and need for treatment, ultimately improving
patient outcomes.”
Freelite assays previously received 510k clearance, following US
Food and Drug Administration (FDA) requirements, for the diagnosis
and monitoring of multiple myeloma, lymphocytic neoplasms,
Waldenstr�m’s macroglobulinemia, AL amyloidosis, light chain
deposition disease and connective tissue diseases such as systemic
lupus erythematosus (SLE). These assays were the first commercially
available FLC tests and are currently the test of choice in over
1,000 laboratories worldwide, including some of the largest
multiple myeloma centers.
In 2023 Thermo Fisher Scientific completed the acquisition of
The Binding Site, adding protein diagnostics solutions, including
diagnosis and monitoring for monoclonal gammopathies, to its
specialty diagnostics portfolio. Attendees of the Association for
Diagnostics and Laboratory Medicine (ADLM) Annual Meeting, taking
place from July 28 to August 1, 2024 in Chicago, Ill., can learn
more about how Freelite can help support their laboratories in
Thermo Fisher’s booth (#2213).
To learn more about the Binding Site Freelite assays, please
visit our website here.
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving
science, with annual revenue over $40 billion. Our Mission is to
enable our customers to make the world healthier, cleaner and
safer. Whether our customers are accelerating life sciences
research, solving complex analytical challenges, increasing
productivity in their laboratories, improving patient health
through diagnostics or the development and manufacture of
life-changing therapies, we are here to support them. Our global
team delivers an unrivaled combination of innovative technologies,
purchasing convenience and pharmaceutical services through our
industry-leading brands, including Thermo Scientific, Applied
Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services,
Patheon and PPD. For more information, please visit
https://www.thermofisher.com/.
References
- Kyle, R.A., et al., Prevalence of monoclonal gammopathy of
undetermined significance. N Engl J Med, 2006. 354(13): p.
1362-1369.
- Rajkumar, S.V., et al., International Myeloma Working Group
updated criteria for the diagnosis of multiple myeloma. Lancet
Oncol., 2014. 15: p. e538-e548.
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Media Contact Information: Marion Hutchins E-mail:
marion.hutchins@thermofisher.com Jessika Parry Phone: 419-266-4016
Email: jparry@greenoughagency.com