Thermo Expands Offering for Clinical Applications at AACC 2016
Product News Aug 02, 2016
Thermo Fisher Scientific will exhibit its expanded offering of new assays, instruments and software at the 2016 American Association of Clinical Chemistry (AACC) Annual Meeting and Clinical Lab Expo being held July 31 - August 4 at the Pennsylvania Convention Center. Designed specifically for customers working in research and clinical settings, these innovative new products will be on display in booths #2334 and #2145.
“Today’s healthcare and clinical service providers are on the front line of a rapidly changing diagnostic landscape,” said Marc. N Casper, president and chief executive officer of Thermo Fisher Scientific. “Our commitment to innovation in specialty diagnostics enables these customers to meet the growing demand for more rapid, sensitive and cost-effective tests that lead to better outcomes for patients.”
The impact of opioid abuse on communities places an increasing burden on the healthcare system as well as the law enforcement community. The new Thermo Scientific DRI Hydrocodone assay offers greater sensitivity to help clinicians obtain faster, more accurate test results. This 510(k)-cleared assay detects hydrocodone in specimen samples. With an increased level of sensitivity, the DRI Hydrocodone assay meets the recently proposed Substance Abuse and Mental Health Administration (SAMHSA) testing guidelines for drugs of abuse.
To help prevent sepsis in hospital patients, a growing concern for clinicians, the company announced that its Thermo Scientific B•R•A•H•M•S Procalcitonin (PCT) assay can now be used in the emergency room or hospital ward to aid in risk assessment for patients prior to their admission to the intensive care unit. Through a novel clinical study, the U.S. Food and Drug Administration (FDA) has expanded Thermo Fisher’s clearance for the use of the PCT assay to support mortality risk assessment over multiple days. The B•R•A•H•M•S PCT test takes just 20 minutes, allowing results to be rapidly available to determine the risk of progression in septic patients and support appropriate clinical decision-making.
For in vitro diagnostics, the company is highlighting its new Thermo Scientific Prelude LX-4 MD HPLC (high performance liquid chromatography) multi-channel instrument, which is listed with the FDA as a class I medical device for general clinical use. Designed to increase productivity and efficiency of clinical sample separations, the Prelude LX-4 MD can run mass spectrometry assays simultaneously for fast, accurate in vitro diagnostic tests.
Thermo Fisher has also received 510(k) clearance from the FDA for two new EliA IgG tests for detecting anti-Thyroglobulin (anti-TG) and anti-Thyroid Peroxidase (anti-TPO) autoantibodies in serum or plasma. Thyroid autoimmunity includes a number of distinct but related autoimmune disorders of the thyroid gland, such as Graves’ disease or Hashimoto’s thyroiditis. Both tests will be featured in the Thermo Fisher booth.
Finally, the new Thermo Scientific LabLink xL 2.0 quality assurance software, in conjunction with Thermo Scientific MAS quality controls, is designed to ensure more accurate results in clinical chemistry methods. This Cloud-based resource allows clinicians to compare and validate control results from labs around the world in real time.