October 27, 2021
AACC SmartBrief
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Business Perspective
Carrie Byington has been added to Becton Dickinson's board of directors. Byington currently serves as the head and executive vice president of University of California Health.
Full Story: MassDevice (Boston) (10/22) 
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Abbott generated $10.9 billion in sales and $2.1 billion in profits during its fiscal third quarter, which ended Sept. 30. "We achieved another quarter of strong growth overall and across all four of our major business areas," said President and CEO Robert Ford.
Full Story: MassDevice (Boston) (10/20) 
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Danaher generated $7.2 billion in sales and $1.2 billion in profits during its third quarter, which ended Sept. 30. "We continued to invest for growth across our businesses, expanding production capacity and accelerating innovation initiatives," said CEO and President Rainer Blair.
Full Story: MassDevice (Boston) (10/21) 
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Policy Briefs
The Center for Medicare and Medicaid Innovation unveiled a "strategic refresh" plan to streamline value-based care payment models and make them more equitable to boost participation from health care providers over the next 10 years. The agency aims for multipayer alignment in all value-based care models and aims to get all Medicare beneficiaries and most Medicaid members into some type of accountable care plan by 2030.
Full Story: Healthcare Dive (10/21),  FierceHealthcare (10/20) 
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Practice Briefs
A request for emergency use authorization has been submitted by Applied DNA Sciences to the FDA for its Linea SARS-CoV-2 Mutation Panel.
Full Story: Seeking Alpha (free registration) (10/25) 
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Roche's VENTANA PD-L1 (SP263) Assay has been approved by the FDA for use as a companion diagnostic to identify patients with non-small cell lung cancer who may be treated with Tecentriq, or atezolizumab. "With the FDA approval of this companion diagnostic test, clinicians now have an effective tool for offering better patient care through targeted immunotherapy treatment," said Roche Diagnostics CEO Thomas Schinecker.
Full Story: Medical Device Network (UK) (10/22) 
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Biological Dynamics has received breakthrough status designation from the FDA for its Exo-PDAC that is used for the early detection of pancreatic ductal adenocarcinoma. "For far too long, patients have needed innovative technologies with the potential to detect cancer at the earliest stages, and we look forward to working closely with the FDA, to do exactly that," said CEO Raj Krishnan.
Full Story: Medical Device Network (UK) (10/21) 
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European regulators have given CE mark certification to Sorrento Therapeutics for its Covistix COVID-19 virus rapid antigen detection test. Based on the results of a large study conducted in Mexico, the test had 81% sensitivity.
Full Story: FDAnews (10/25) 
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Submit Poster Abstracts for the 2022 Preanalytical Phase Conference
AACC's Preanalytical Phase conference planning committee invites you to submit a poster abstract for the 2022 Preanalytical Phase Conference to be held March 25-26, 2022, in Alexandria VA, USA. Poster abstract submission is free and multiple submission are welcome. Submission Deadline: November 3, 2021
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Business/Corporate Briefs
The White House will spend $70 million to accelerate development of COVID-19 tests for home use to make the tests more accessible and lower their costs. The NIH Independent Test Assessment Program will set up an accelerated pathway to support FDA assessment of COVID-19 tests for potential large-scale manufacturing and identify and assist manufacturers in development of their products.
Full Story: United Press International (10/25) 
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AACC News
Don't miss your chance to present to a global audience of laboratory medicine professionals at the 2022 AACC Annual Scientific Meeting & Clinical Lab Expo, held at McCormick Place, Chicago, Illinois from July 24-28, 2022. Submission is free and proposals can be submitted for a scientific session, roundtable session, or AACC University course. Submission Deadline: Thursday, November 4, 2021, 5 p.m. US Eastern Time.
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AACC's Preanalytical Phase conference planning committee invites you to submit a poster abstract for the 2022 Preanalytical Phase Conference to be held March 25-26, 2022, in Alexandria VA, USA. Poster abstract submission is free and multiple submission are welcome. The submission deadline is approaching: Next Wednesday November 3, 2021
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