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Sysmex America gets FDA nod for complete blood cell count test

MDBR Staff Writer Published 07 November 2017

Sysmex America has secured approval from the US Food and Drug Administration (FDA) for a complete blood cell count (CBC) test.

The XW-100 automated hematology analyzer has been approved for use in patients two years of age and older who need a whole blood cell count and white blood cell differential

Sysmex’s new CBC test can be used in different health care settings, including physicians’ offices, clinics or other types of health care facilities.

The results obtained from the test can be used with other clinical and laboratory findings to offer early alerts of patients with serious conditions such as severe anemia and granulocytosis.

Sysmex’s new automated hematology analyzer cannot be used to diagnose or monitor patients with primary and secondary hematologic diseases such as oncology and critically ill patients.

The device uses a blood sample to classify and quantify12 different blood characteristics, providing patients with a complete blood component profile.

FDA approval was based on the data from a study carried out on 582 samples collected from patients ranging from two to 92 years old.

The study compared the results of XW-100 test collected by non-medical personnel in CLIA-waived settings to a hematology analyzer in an accredited clinical laboratory.

FDA’s Center for Devices and Radiological Health’s in vitro diagnostics and radiological health office acting director Donald Pierre said: “A CBC is one of the most common physician-ordered tests used to evaluate a patient’s blood levels, determine if an infection is present and if immediate intervention is needed.

“However, in the current health care setting, non-hospitalized patients who require a CBC can experience at least a 24-hour wait for test results, if not longer, when the test is performed by an off-site laboratory.”


Image: The FDA campus in New Hampshire Ave, Silver Spring, Maryland. Photo: courtesy of The U.S. Food and Drug Administration.