LINCOLNSHIRE, Ill., Nov. 8, 2017 /PRNewswire/ -- Sysmex America announced today that its Sysmex XW-100 received clearance from the U.S. Food and Drug Administration (FDA)—making it the first Clinical Laboratory Improvement Amendments (CLIA)-waived, complete blood count (CBC) system. Once prepared for each day's use, the XW-100 will allow health care professionals to provide patients with blood test results in as few as three minutes.
The new Sysmex XW-100 automated hematology analyzer makes it possible for one of the most frequently requested blood tests to be conducted in more of the approximately 80,000 U.S. medical practices where patients are first treated, such as physicians' offices. Today, only 32% of primary care facilities offer on-site testing, while others send blood work to outside laboratories and await the results.
"The XW-100 is a breakthrough that will transform blood testing for patients and the health care professionals who treat them," said Ralph Taylor, chief executive officer of Sysmex America. "In addition to making faster treatment plans possible, the technology will improve the efficiency of health care delivery."
The new Sysmex instrument's ease of use makes it possible for tests to be conducted by in-house staff in just a few easy steps, without the certification required for the operation of more complex, sophisticated diagnostic equipment. The easy-to-operate XW-100 can analyze a sample and provide results in about the same time it takes to send a test for outside analysis. It offers a simple interface and an array of features, such as a physician alert if additional testing is required.
Provides patients with faster answers and earlier start of treatment
According to the Health Industry Distributors Association, while laboratory tests represent just 2% of health care spending, they influence 70% of medical decisions. The XW-100 allows a physician to determine what may be affecting a patient, and start a treatment plan – and likely on the path to better health – faster. For example, doctors rely on a variety of methods to determine whether infections are caused by bacteria or a virus, and CBC tests are among the first screenings in the process.
The Sysmex XW-100 will enable faster and better care, more time with patients and operational efficiency for health care practices. Today, lab tests sent to an outside provider are usually returned the next day, at the earliest. Staff then contact the patient to share results, which can result in additional time and cost for both the medical practice and patient as multiple attempts are made to reach each other.
In addition, faster results can alleviate patient concern regarding the cause of their symptoms, similar to other CLIA-waived tests, such as using a throat swab to quickly determine whether a patient has strep throat. With the Sysmex XW-100, patients can receive the results in minutes, during the very same visit to the doctor's office.
Saves time, cost and trips to the doctor's office
According to a 2016 study, 37% of patients said that not being able to get laboratory results during the same visit was the reason a health provider failed to meet their expectations. In the study, patients said they wanted to avoid travel to more than one location, and eliminate follow-up visits to discuss test results. A physician's office equipped with the new XW-100 will help make that happen.
And with a height of 13.8 inches and width of 7.3 inches, the compact instrument conveniently fits in any facility.
Sysmex's XW-100 uses a 15 µL sample size of venous blood to provide a CBC with a three-part white blood cell differential, offering twelve clinically useful results, all of which are available in as few as three minutes. For a complete list of results offered by the Sysmex XW-100, click here.
Rigorously developed, and built on 50 years of diagnostic leadership
"The XW-100 is the culmination of a long journey to develop a high-quality hematology analyzer able to deliver accurate and reliable results in a CLIA-waived primary care setting," said Andy Hay, chief operating officer of Sysmex America. "During that time, Sysmex made considerable investments in comprehensive testing and market acceptance studies, as well as in building a robust infrastructure and related systems to ensure the XW-100 safely serves health care professionals and the patients who depend on them."
The XW-100 is built on the company's reliable, trusted and proven technology honed by Sysmex scientists over the past half-century. Today, Sysmex is the hematology diagnostic leader in the U.S., Asia and Europe. According to U.S. News & World Report's 2017-2018 list of best hospitals, nine of the top ten hospitals in the U.S. rely on Sysmex hematology analyzers to treat their patients.
Sysmex expects to begin shipping the XW-100 in early 2018. Click here to learn more about equipping a physician's office with the technology that provides the most common blood test results in just minute.
To learn more about CBC tests, click here.
About Sysmex America
Sysmex America, Inc. distributes and supports a diverse portfolio of best-in-class, in vitro diagnostic hematology and clinical laboratory products in the U.S., Canada and Latin America. It is the U.S. regional office of Sysmex Corporation, a trusted world leader in clinical laboratory solutions that optimize efficiency, operations and financial performance in the lab, located in Kobe, Japan. Sysmex is reshaping the health care of tomorrow at the clinical laboratory level by transcending the boundaries of diagnostic science and serving as the pulse of reliable, accountable care. In 2017, Forbes magazine named Sysmex the most innovative company in the health care equipment and services category. For more information about Sysmex America, visit www.sysmex.com/us.
SOURCE Sysmex America, Inc.