Hydrocodone, Brahms PCT assays, 10/16

At the AACC show 2016

October 2016—Thermo Fisher Scientific exhibited its expanded offering of new assays, instruments, and software designed specifically for customers working in research and clinical settings. The Thermo Scientific DRI Hydrocodone assay detects hydrocodone in specimen samples and is FDA 510(k) cleared. With an increased level of sensitivity, the assay meets the recently proposed Substance Abuse and Mental Health Services Administration testing guidelines for drugs of abuse.

To help prevent sepsis in hospital patients, the company announced that its Brahms Procalcitonin (PCT) assay can 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 FDA has expanded Thermo Fisher’s clearance for the use of the PCT assay to support mortality risk assessment over multiple days. The test takes 20 minutes, allowing results to be rapidly available to determine the risk of progression in septic patients and support appropriate clinical decision-making.

The company highlighted its Prelude LX-4 MD high-performance liquid chromatography multichannel 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 in vitro diagnostic tests.

Thermo Fisher has also received 510(k) clearance from the FDA for two 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.

The 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.

Thermo Fisher Scientific, 781-622-1000