IL-6 test receives EUA to help assess dysregulated inflammation
February 2021—The FDA has issued an EUA for Siemens Healthineers’ IL-6 assay to measure the presence of interleukin-6 in human serum or plasma.
The test can be used to help identify a severe inflammatory immune response in patients confirmed to have COVID-19, to aid in determining the risk of intubation with mechanical ventilation, in conjunction with clinical findings and other lab test results.
Biocare unveils Oncore Pro for IHC and ISH
Biocare Medical released its fully automated staining platform Oncore Pro for IHC and ISH applications.
The IVD-labeled Oncore Pro Automated Slide Staining System makes it possible to perform IHC, ISH, FISH, and CISH in a single compact benchtop platform. Oncore Pro processes up to 36 slides in a single run and is able to perform independent protocols at each slide position for high-throughput slide processing.
Slide processing is facilitated by reaction modules that enclose slides between a heated platform and a reagent containment chamber. Reagents are dispensed onto slides through a port attached to each chamber, allowing for minimal reagent usage and waste production. These chambers provide gentle agitation to enhance incubation throughout the staining procedure to maximize staining intensity and minimize background. The Oncore Pro also accommodates simultaneous multiplex IHC.
Thermo Fisher to acquire Mesa Biotech
Thermo Fisher Scientific entered into a definitive agreement to acquire molecular diagnostic company Mesa Biotech for about $450 million in cash. Under the agreement’s terms, Thermo Fisher will pay up to an additional $100 million in cash upon the completion of certain milestones after the close of the transaction, which is expected in the first quarter of this year.
Mesa Biotech developed and commercialized a PCR-based rapid point-of-care testing platform for detecting infectious diseases including SARS-CoV-2, influenza A and B, respiratory syncytial virus, and strep A. The company, based in San Diego, has about 500 employees and had revenues last year of about $45 million.
Mesa’s Accula Flu A/Flu B, RSV, and Strep A tests have obtained 510(k) clearance and CLIA waivers from the FDA. The Accula system received EUA for SARS-CoV-2 IVD testing.
Roche launches CE-IVD digital pathology IA algorithms
Roche announced the CE-IVD launch of its automated digital pathology algorithms, uPath HER2 (4B5) image analysis and uPath Dual ISH image analysis.
uPath HER2 (4B5) image analysis for breast cancer helps determine whether tumors are positive for the HER2 biomarker, highlighting positively stained tumor cell membranes with a clear visual overlay for reference. uPath HER2 Dual ISH assists in the determination of HER2 gene amplification. A heatmap is provided to guide pathologists to areas of interest.
The algorithms, validated on the Ventana HER2 (4B5) assay and the Ventana HER2 Dual ISH DNA Probe Cocktail, are ready to use and integrated within the Roche uPath enterprise software.
AMP steering committee takes on pandemic communication, coordination
The Association for Molecular Pathology has formed a COVID response steering committee to help coordinate and communicate the AMP’s efforts to guide diagnostic testing during the COVID-19 pandemic and preparations for future emerging pandemics.
Committee members will share expertise and provide recommendations to key stakeholders, including the Biden administration.
“AMP members have been on the frontlines of this pandemic and have been responsible for managing the ever-increasing demand for testing despite numerous regulatory, reimbursement, supply chain, logistical, and systems challenges,” Frederick Nolte, PhD, chair of the steering committee, said in a Jan. 26 AMP statement. He said the committee will monitor and analyze the accomplishments and challenges laboratory professionals experience in the COVID-19 pandemic.
“We will broadly communicate this information and our membership’s deep expertise as part of our ongoing commitment to informing federal policy, guiding health care providers, and educating the public,” he added, noting the group aims to improve diagnostic testing for COVID-19 and emerging outbreaks.
In addition to Dr. Nolte, who is with the Medical University of South Carolina, the group’s members consist of Karen Kaul, MD, PhD, NorthShore University HealthSystem; Eric Konnick, MD, University of Washington; Jordan Laser, MD, Northwell Health; Timothy O’Leary, MD, PhD, formerly of the Department of Veterans Affairs; Antonia Sepulveda, MD, PhD, George Washington School of Medicine; Karen Weck, MD, University of North Carolina; and Donna Wolk, PhD, Diagnostic Medicine Institute at Geisinger.
Latest on COVID-19
Editor’s note: See captodayonline.com for news on SARS-CoV-2 tests (Coronavirus News). A list of FDA EUAs for COVID-19 can be found at https://j.mp/covid-19-EUA.