HemoCue Receives First FDA CLIA Waiver in Diagnostics Industry for Quantitative Point-of-Care Test for Microalbuminuria, a Kidney and Cardiovascular Disease Risk Marker
MADISON, N.J., June 18 /PRNewswire-FirstCall/ — HemoCue(R) AB, a global point-of-care diagnostic test manufacturer and wholly owned subsidiary of Quest Diagnostics Incorporated , today announced that its HemoCue Albumin 201 System is the first quantitative point-of-care test for screening for, diagnosing and monitoring microalbuminuria to be granted a CLIA waiver by the U.S. Food and Drug Administration (FDA). With the FDA CLIA waiver, non-laboratory trained physicians and other health care professionals in any health care facility with a CLIA Certificate of Waiver in the U.S. will be able to use the HemoCue Albumin 201 System to screen patients for microalbuminuria and begin treatment based on the test’s results during a single office visit.
Microalbuminuria may indicate the presence of chronic kidney disease (CKD), a life-threatening condition that affects approximately 26 million Americans. Diabetes and hypertension are the two leading risk factors for developing CKD. Microalbuminuria also is an independent risk factor for developing cardiovascular disease in patients with or without diabetes or hypertension.
“Given that microalbuminuria is a risk marker for cardiovascular disease, and its increase over time can indicate kidney disease, it is important that physicians have a fast, easy, reliable test to assess changes in their patients,” said professor George L. Bakris, M.D., Director of the Hypertensive Diseases Unit at the University of Chicago-Pritzker School of Medicine. “The availability of a point-of-care test that accurately measures albumin in urine is expected to have a positive impact on physicians’ ability to screen in-office and then begin treatment for patients at risk for microalbuminuria, such as those with diabetes or hypertension.”
Microalbuminuria is a condition characterized by the presence of albumin, a protein, excreted in urine. As the albumin excretion increases, so does the risk of CKD or cardiovascular disease onset and progression. The HemoCue Albumin 201 System, which produces results within 90 seconds, enables physicians to identify and quantify low levels of albumin at the point of care for the purpose of screening for, diagnosing, monitoring and to supplement clinical evidence in the treatment of microalbuminuria. Unlike semiquantitative urine “dipstick” methods, which indicate if a patient’s microalbumin levels fall within pre-defined ranges, the HemoCue Albumin 201 System provides the actual concentration present in the sample. Using the HemoCue Albumin 201 System, physicians may monitor changes in microalbumin excretion in a patient over time.
A study in the American Journal of Nephrology (2008;28:324-329) published online in November 2007 concluded that the “HemoCue Albumin 201 System is a valid and precise method for UAE (urinary albumin excretion) determination, exhibiting a performance similar to laboratory ACR (albumin-to-creatinine) estimations and far better than the widely used dipsticks … the HemoCue Albumin 201 System appears to be a convenient solution for detection of abnormal UAE levels.” The study involved 165 adult subjects under treatment for hypertension at the Rush University Medical Center in Chicago. Dr. Bakris was the study’s lead investigator. HemoCue AB financially supported the study.
According to the American Diabetes Association (ADA) and the National Kidney Foundation (NKF), physicians should assess urine albumin excretion annually in patients with type 2 diabetes commencing at the time of diagnosis as well as in patients with type 1 diabetes who have had the disease for five years. The NKF further recommends that patients at increased risk for chronic kidney disease, such as those with hypertension, be offered microalbumin screening during periodic health evaluations. Microalbuminuria screening can help physicians detect CKD in the early stages — before symptoms appear — when treatment can halt or reverse its progression.
Despite evidence-based medical guidelines, a March 2008 Quest Diagnostics Health Trends Report on Chronic Kidney Disease found that only 32.7 percent of patients with type 1 or type 2 diabetes and/or hypertension received a microalbumin test for CKD during the twelve-month period ending in October 2006. The study is based on results of tests performed by Quest Diagnostics on patients in the U.S. Diabetes affects seven percent of the U.S. population and more than 21 percent of adults over age 60. Hypertension affects approximately 30 percent of American adults and more than half of those over age 60.
“Our recent Health Trends data suggest that fewer at-risk patients are receiving microalbumin tests than would be expected if the established medical guidelines were universally applied,” said Stephen C. Suffin, M.D., interim chief laboratory officer and corporate clinical pathologist — science and technology, Quest Diagnostics. “The availability of a fast, reliable point-of-care test that physicians can perform in their own offices to quantitatively assess microalbumin may help patients at risk for CKD to begin receiving the care they need at the time of their appointment with their physician.”
In addition to CKD and cardiovascular disease, microalbuminuria may also suggest the potential development of preeclampsia, a potentially life-threatening condition that can affect a pregnant woman, particularly those with type 1 diabetes, and her fetus. In patients with diabetes, microalbuminuria may suggest the potential to develop diabetic retinopathy, the leading cause of blindness among adults in the U.S.
The HemoCue Albumin 201 System received FDA 510(k) clearance in the first quarter of 2006. It was CE marked for distribution to more than 30 countries in Europe during the fourth quarter of 2005.
About CLIA Waiver
The U.S. Congress passed the Clinical Laboratory Improvement Amendments (CLIA) in 1988 to establish federal quality standards for the clinical laboratory testing industry. The FDA grants CLIA waivers to FDA 510(k)-cleared tests that are “simple” and have an “insignificant risk of producing an erroneous result.” CLIA waived tests may be performed by non-laboratory trained health care workers at any facility that fulfills certain minimal requirements, such as holding a CLIA Certificate of Waiver and following manufacturer instructions.
HemoCue, a Quest Diagnostics company, is a leading global company in a field of diagnostics known as near patient, or point-of-care, testing. In 1982, HemoCue introduced the first system making accurate hemoglobin testing possible in near patient settings. The system consists of a handheld instrument and a disposable microcuvette (micro sample collection system) used with each test. Since then, HemoCue has sold more than 250,000 systems worldwide and sells more than 100 million test cuvettes annually. The company has subsidiaries and affiliates in the U.S., Germany, Finland, Switzerland, the Netherlands, and the UK, with franchises and third-party distributors generating revenue in more than 100 countries. Quest Diagnostics acquired HemoCue in 2007. HemoCue is based in Angelholm, Sweden. Additional information is available at http://www.hemocue.com/.
About Quest Diagnostics
Quest Diagnostics is the leading provider of diagnostic testing, information and services that patients and doctors need to make better healthcare decisions. The company offers the broadest access to diagnostic testing services through its national network of laboratories and patient service centers, and provides interpretive consultation through its extensive medical and scientific staff. Quest Diagnostics is a pioneer in developing innovative new diagnostic tests and advanced healthcare information technology solutions that help improve patient care. Additional company information is available at: http://www.questdiagnostics.com/.
The statements in this press release that are not historical facts or information may be forward-looking statements. These forward-looking statements involve risks and uncertainties that could cause actual results and outcomes to be materially different. Certain of these risks and uncertainties may include, but are not limited to, competitive environment, changes in government regulations, changing relationships with customers, payers, suppliers and strategic partners and other factors described in the Quest Diagnostics Incorporated 2007 Form 10-K and subsequent SEC filings.
Quest Diagnostics Incorporated
CONTACT: Investors, Laure Park, +1-973-520-2900, or Media, Wendy Bost,+1-973-520-2800, both of Quest Diagnostics
Web site: http://www.questdiagnostics.com/http://www.hemocue.com/