New CBC Test Approved by FDA

In a recent announcement from the US Food and Drug Administration (FDA), the government agency stated that they have “cleared a complete blood cell count (CBC) test that, based on its categorization, can be run in more health care settings, including physicians’ offices, clinics or other types of health care facilities, by a wider range of personnel (eg, support staff). This broadened test access will allow for faster availability of results.”

Although a CBC is one of the most common physician-ordered tests to evaluate a patient’s blood, according to the FDA, oftentimes those patients who require the test who are not in the hospital may need to wait 24 hours to receive the results of the test, and sometimes, even longer. This is because the test is performed by an off-site laboratory (as opposed to onsite when it is performed in the hospital.) This delay could negatively impact patient outcomes as both doctor and patient are required to wait for the results, potentially delaying necessary treatment.

The new test approved by the FDA, the XW-100 Automated Hematology Analyzer, has the potential to decrease the time to results because it will be available in settings without onsite lab facilities, such as a physicians’ office. A study of data collected from 582 samples from patients ranging in age from 2 to 92 found that when users followed the manufacturer’s instructions for use, “accurate testing can be effectively conducted by untrained personnel.”

According to the announcement, “the XW-100 Automated Hematology Analyzer, which works by using a blood sample to classify and quantify 12 different blood characteristics (hematology parameters), which provides patients with a blood component profile as part of their overall health assessment, is intended for use in patients 2 years of age and older who require a whole blood cell count and white blood cell differential.” The results of the test, in conjunction with other lab and clinical results, can provide, “early alerts of patients with serious conditions such as severe anemia (low red blood cell or hemoglobin count) and agranulocytosis (low white blood cell count), who require additional testing,” according to the announcement. The announcement notes that the test is “not intended to diagnose or monitor patients with primary and/or secondary hematologic diseases, including oncology and critically ill patients.”

Because the device was granted a waiver under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), it is able to be used in those sites that are non-traditional laboratory sites. These include physicians’ offices or other facilities with a CLIA Certificate of Waiver.

The FDA granted premarket clearance and a CLIA waiver for the XW-100 Automated Hematology Analyzer to Sysmex America, Inc.