PRODUCT FOCUS :: :NEW PRODUCTS


when the HbA1c interpretation is problematic such as in the presence of hemoglobinopathies, iron deficiency, and anemias. Another key feature of glycated albumin is that it changes more rapidly and markedly than HbA1c. Therefore, GA is a good marker to monitor the effects of changes in therapy in patients with diabetes when more rapid treat- ment responses are needed.


Thermo Fisher showcased range of products Thermo Fisher Scientific launched a range of


products during AACC’s 2021 meeting. To support ongoing COVID-19 testing, Thermo Fisher


launched two new PCR-based kits, the Applied Biosystems TaqPath COVID-19 Fast PCR Combo Kit 2.0 and the Applied Biosystems TaqPath COVID-19 RNase P Combo Kit 2.0. The kits target eight genes across three regions of the virus that causes COVID-19. Additionally, the company announced that the Mu variant is now included in its existing Applied Biosystems TaqMan SARS-CoV-2 Mutation Panel. Thermo Fisher also launched the new Thermo Scientific AcroMetrix SARS-CoV-2 Control for monitoring extraction, amplification and detection steps for SARS-CoV-2 assays. In addition to COVID-19 testing, the company also demon- strated a new Fentanyl assay, DRI Fentanyl II, for labs involved in drug screening. The U.S. Food and Drug Administration recently granted the product 510(k) approval. Thermo Fisher Scientific also partnered with Mindray to


provide two new high-performance analyzers, the Mindray BS480 and Mindray BA800M. These new analyzers and an expanding assay portfolio equip labs with the flexibility to run up to 800 tests per hour, the company said. In the area of autoimmune diseases, Thermo Fisher show- cased the EliA SmDP-S test. Cleared by the U.S. Food & Drug Administration (FDA), it aids in the diagnosis of Systemic Lupus Erythematosus (SLE), the most common type of lupus.


20/20 GeneSystems launched lab product incubator 20/20 GeneSystems launched a business incubator for clinical lab products. Called Clinical Lab Innovation Axcellerator (CLIAx), the company said it believes the facility is the first shared CLIA laboratory facility geared to helping diagnostic test innovators worldwide substantially reduce the time and cost of launching their tests in the U.S.


“Establishing and maintaining a compliant CLIA lab can


be costly and daunting for young companies, especially those seeking to enter the American market from overseas,” 20/20 President and CEO, Jonathan Cohen said. “Our unique CLIA Axcellerator removes or lowers many of the barriers in the path of these innovators.” CLIAx has nearly 3,000 square feet of ready-to-use communal clinical laboratory space and testing equipment, including a full PCR/molecular assay suite, NextGen Sequencing (NGS), immunoassay, and clinical chemistry capabilities. Importantly, 20/20’s marketing and sales teams will help promote the new tests introduced by CLIAx’s clients to the market segments in which 20/20 is currently active. Earlier this month the company signed an agreement with


Australian-based Minomic International, a diagnostics firm that is gearing up to introduce MiCheck Prostate, a blood test that uses proprietary algorithms and biomarkers to estimate the risk of aggressive prostate cancer. CLIAx was officially designated by the Maryland Depart- ment of Commerce as a “Soft Landing” program for overseas companies seeking to enter the U.S. market. “Maryland is ‘open’ for international companies looking to expand, and the new Clinical Laboratory Innovation Axcellerator will provide the perfect soft landing for those seeking to explore the U.S. market,” said Maryland Commerce Secretary Kelly M. Schulz. 20/20 GeneSystems, based in Rockville, MD, offers OneTest, a blood test to aid in the early detection of multiple cancers, as well as several COVID-19 testing solutions including viral tests based on PCR and point-of-care, rapid antibody and antigen tests.


INDEX OF ADVERTISERS Advertiser ...................................................................................Web ................................................................................................................................ Page


Abbott Diagnostics .................................................................... technopathcd.com ............................................................................................................BC Arkray ......................................................................................... arkrayusa.com ....................................................................................................................27 Hologic - Total Health ................................................................. hologic.com ..................................................................................................................Cover Hologic - Total Health ................................................................. hologic.com .................................................................................................................IFC - 1 Hologic - Total Health ................................................................. hologic.com ........................................................................................................................31 Hologic - Total Health ................................................................. hologic.com/aptimamultitest ..............................................................................................5 Instrumentation Laboratory - Acute Care ................................ werfen.com .........................................................................................................................17 Kronus ........................................................................................ kronus.com .........................................................................................................................33 LabVantage Solutions , Inc........................................................ labvantageclinical.com/mlo12 ..........................................................................................41 LumiraDx - Fast Lab Solutions.................................................. lumiradx.com .....................................................................................................................15 LumiraDx - Platform .................................................................. lumiradx.com .....................................................................................................................45 Nova Biomedical ........................................................................ novabiomedical.com .........................................................................................................25 NovoPath LLC ............................................................................. novopath.com ....................................................................................................................40 Orchard Software ....................................................................... orchardsoft.com .................................................................................................................43 Qiagen, Inc. ................................................................................ qiagen.com/respiratory .....................................................................................................21 Qorvo US, Inc. ............................................................................ qorvobiotech.com ............................................................................................................IBC Quantimetrix .............................................................................. quantimetrix.com ...............................................................................................................35 Quidel ......................................................................................... quidel.com .................................................................................................................... 11, 37 Randox Laboratories ................................................................. randox.com ........................................................................................................................29 Sight Diagnostics, Inc. ............................................................... sightdx.com ..........................................................................................................................3 Sysmex America Inc .................................................................. sysmex.com/ua ..................................................................................................................39 TechLab ....................................................................................... techlab.com ........................................................................................................................20


This index is provided as a service. The publisher does not assume liability for errors or omissions. MLO-ONLINE.COM DECEMBER 2021 47


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