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South Bend Medical Foundation to sell lab testing assets to LabCorp

August 2019—South Bend Medical Foundation announced its intention to sell its diagnostic clinical laboratory testing assets to LabCorp. The transaction is expected to close in the third quarter of this year.

SBMF said in a statement that it will reinvest the proceeds from the sale into the organization to enhance and modernize facilities and procedures and ensure the ability to fund retiree pensions. The decision, it said, will help further secure the future of SBMF and allow the organization to focus on its core business of pathology and blood banking services.

Abbott launches rapid POC HbA1c test

Abbott announced in June that its Afinion HbA1c Dx assay is available for use on the Afinion 2 analyzer.

The Afinion HbA1c Dx assay is the first rapid point-of-care test cleared by the Food and Drug Administration to aid in diagnosing and assessing risk for diabetes. It had been cleared for use on the Afinion AS100 analyzer in 2018.

Abbott says the Afinion HbA1c Dx meets the FDA’s requirements for performance testing for diagnostic use claims and that results are provided in three minutes. The assay, approved for monitoring and diagnosis, complements the Afinion HbA1c assay, which is approved for monitoring only.

The Afinion 2 platform was launched in 2018 for patient management of diabetes through whole blood HbA1c testing and ACR testing in urine.

ddPCR MSI RUO assay for early access customers

Bio-Rad’s Droplet Digital PCR Microsatellite Instability RUO Assay is available for early access customers. The ddPCR MSI assay can be completed in one day on a ddPCR-based platform to quantify the level of MSI in colorectal tumors.

Using either a blood or formalin-fixed, paraffin-embedded sample, the assay quantitatively identifies mutations in five loci that lead to identification of MSI status. Colorectal tumors that test positive for MSI-high are candidates for treatment with immune checkpoint inhibitors.

The test can use patient blood samples in the absence of tumor tissue and does not require matched normal tissue or normal blood samples.

FDA approves Alinity s System

The Food and Drug Administration approved Abbott’s blood and plasma screening Alinity s System. Alinity s is designed to screen blood and plasma more efficiently within a smaller space than that of commercially available competitive systems, Abbott said in a statement.

“Alinity s is a significant leap forward when it comes to speed, automation, and efficiency for blood and plasma screening,” Louis Morrone, Abbott vice president of transfusion medicine, said in the statement.

Abbott says the Alinity s does the following:

• • Expands capacity to run up to 600 tests per hour.
  • Improves centers’ ability to track all activities and actions associated with the testing and processing of each donation in accordance with regulatory requirements.
  • Increases walkaway time to a minimum of three hours while adding the ability to continuously access to refill/restock when convenient to the technician.
  • Provides the ability to continuously load and unload samples and supplies without pausing or stopping the system.
  • Features an intuitive software interface, menu design, and sample loading layout, shared with other Alinity instruments.

AABB issues recommendations to decrease group O blood overuse

In response to blood shortages in many regions of the United States, the AABB in June released a series of recommendations to help blood collection facilities and hospitals decrease the overuse of group O blood.