Laboratories, Inc. SDMA Study Citations and Additional Resources
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5. Lulich JP, Osborne CA, O’Brien TD, Polzin DJ. Feline renal failure: questions, answers, questions. Compend Contin Educ Pract Vet. 1992;14(2):127–153.
6. American Veterinary Medical Association. U.S. Pet Ownership and Demographics Sourcebook. Schaumburg, IL: AVMA; 2012
7. Schaumburg, IL: AVMA; 2012.
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Monday, December 14, 2015
Breakthrough SDMA Kidney Function Test Now Available From IDEXX Laboratories, Inc.
WESTBROOK, Maine , July 13, 2015 /PRNewswire/ -- IDEXX Laboratories, Inc. (NASDAQ: IDXX) announced today that a breakthrough kidney function test, called symmetric dimethylarginine or SDMA, will now be automatically included in all routine chemistry panels from IDEXX Reference Laboratories in the U.S. at no additional cost and with the same rapid turnaround time as routine chemistry panels.
This groundbreaking new renal biomarker identifies the onset of kidney disease months or even years earlier than traditional methods, greatly expanding clinical insights and treatment options in cats and dogs. The test arrives on the market after several years of research and clinical studies, culminating in 27 peer-reviewed articles to date and following an extensive pilot launch involving over 600 veterinary practices in which more than 50,000 SDMA tests were successfully run and used to diagnose potential kidney disease.
"SDMA is the best thing that's happened in kidney disease management in decades," said Travis Pond , DVM, of American Pet Hospital in Las Vegas, Nevada . "The ability to detect kidney disease early in the disease process is a real game changer for my patients and their families. This kind of innovation is really helping to raise the standard of care."
Chronic kidney disease (CKD) is a leading cause of suffering and death in cats and dogs. It has been generally accepted that 1 in 3 cats 1 and 1 in 10 dogs 2 will develop some form of kidney disease over their lifetime however, recent studies suggest that CKD is even more common. These studies indicate that CKD affects 40% of cats less than 15 years of age and up to 80% of cats over 15 years of age. These results indicate that CKD has been under-recognized previously. 3,4
Until today, kidney disease has been routinely diagnosed in part by measuring blood creatinine. However, creatinine cannot detect kidney disease until late in the disease process, limiting the opportunity to extend the life of the pet through treatment options. Traditionally, a diagnosis is made when 75% of kidney function has been irreversibly lost. At this point, the prognosis can be poor.
The SDMA test changes that. In recent clinical studies at Texas A&M University and Oregon State University , research revealed that SDMA identified disease much earlier in disease progression, when the kidney had suffered far less damage. The Oregon State University study demonstrated SDMA detected CKD up to 4 years earlier in at least one animal. On average, SDMA detected kidney disease when only 40%and in some cases 25%of function had been lost.
Additional research identified SDMA as a better indicator of renal function in animals that have lost muscle mass because of age or disease. SDMA is not impacted by body mass, whereas creatinine levels are. Earlier detection allows veterinarians to recommend potentially effective intervention that could add months or even years to pet lives.
"SDMA appears to be a major step forward in our diagnostic approach to chronic kidney disease," said Greg Grauer , DVM, MS, DACVIM, professor and Jarvis chair of small animal internal medicine, Kansas State University . "The potential role of SDMA in diagnosing chronic kidney disease, especially early chronic kidney disease, is a promising new direction in veterinary nephrology."
Since April 2015 , over 600 veterinary practices have received SDMA results from IDEXX Reference Laboratories when they submitted routine chemistry panels as part of a pilot launch. To date, more than 50,000 tests have been run on patients in practice. Participating veterinarians and the pets in their care have already begun to benefit from the opportunity SDMA offers for early diagnosis of CKD.
"SDMA is a result of our industry-leading investment in advancing veterinary medicine and represents a significant achievement in preventive care diagnostics," said Jonathan W. Ayers , president and chief executive officer of IDEXX Laboratories. "Customers participating in our pilot launch have told us that SDMA has already transformed the way kidney disease is diagnosed and treated, and will help their patients live longer, happier lives."
The SDMA test will roll out in the Canadian market as part of the routine chemistry panel later this summer. A roll-out in our global reference laboratory network will extend into 2016.
For more information about SDMA, visit idexx.com/sdma or call 1-888-433-9987.
About IDEXX Laboratories
IDEXX Laboratories, Inc. is a leader in pet healthcare innovation, serving practicing veterinarians around the world with a broad range of diagnostic and information technology-based products and services. IDEXX products enhance the ability of veterinarians to provide advanced medical care, improve staff efficiency and to build more economically successful practices. IDEXX is also a worldwide leader in providing livestock and poultry diagnostic tests and tests for the quality and safety of water and milk. Headquartered in Maine , IDEXX Laboratories employs more than 6,000 people and offers products to customers in more than 175 countries.
1. Lulich JP, Osborne CA, O'Brien TD, Polzin DJ. Feline renal failure: questions, answers, questions. Compend Contin Educ Pract Vet. 199214(2):127153.
3. Marino CL, Lascelles BD, Vaden SL, Gruen ME, Marks SL. The prevalence and classification of chronic kidney disease in cats randomly selected from four age groups and in cats recruited for degenerative joint disease studies. J Feline Med Surg. 201416(6):465472.
4. Data on file at IDEXX Laboratories, Inc. Westbrook, Maine USA.
The diagnosis of kidney disease is multifaceted, including assessment of patient signalment, history, clinical signs, physical examination findings, and results of diagnostic testing, including hematology, biochemistry, urinalysis, medical imaging and ancillary evaluations such as blood pressure measurement. Veterinary clinicians utilize laboratory assessment of sCr and BUN to diagnose kidney disease, analytes which have been shown to be insensitive, late markers of kidney dysfunction [7–9, 22] and non-specific, namely, influenced by extrarenal factors . SDMA is a more sensitive and earlier indicator of kidney function that can indicate progressive kidney function loss before other parameters and is less influenced by extra-renal factors [3, 11, 13–15]. Accurate and precise SDMA measurements are needed to optimize patient diagnosis and management based on standardized IRIS CKD staging and individual patient concerns. When compared to SDMA measured by LC-MS on the same individual patient samples, IDEXX SDMA Test results showed strong agreement. In this study SDMA concentrations measured with the IDEXX SDMA Test were substantially more accurate and more precise in macroscopically normal serum than those measured with the DLD SDMA ELISA when compared to the reference method of LC-MS.
Bias of a diagnostic test can negatively impact appropriate medical interpretation. For the IDEXX SDMA Test estimated bias over the clinically relevant range (10–45 μg/dL) was 1 to 3 μg/dL. In contrast, the DLD SDMA ELISA showed considerable bias over the clinically relevant range, from 5 to -17 μg/dL. For the IDEXX SDMA Test a small proportional bias was noted for canine and feline samples near the cutoff of 14 μg/dL, (Fig 2(A)) whereas, the DLD SDMA ELISA revealed a moderate bias (Fig 2(B)). The biases reported for the DLD SDMA ELISA not only impact the accurate assessment of kidney function in individual diagnostic tests, but also alter the therapeutic recommendations and laboratory monitoring of patients for progressive kidney disease. Near the SDMA cutoff of 14 μg/dL the DLD SDMA ELISA can overestimate or underestimate kidney function, which could lead to a false positive diagnosis of kidney disease, or perhaps more importantly, a failure to diagnose early kidney disease. Missed opportunities to identify and treat reversible causes and contributors to progressive kidney disease may negatively impact patient outcome. At concentrations of SDMA ≥ 30 μg/dL the DLD SDMA ELISA had a negative bias of ≥ 7.57 μg/dL (Table 2), which could lead to incorrect assessment of moderate to severe kidney disease, as kidney function is overestimated. The difference in systematic bias between the two methods supports the clinical use of the more accurate IDEXX SDMA Test rather than DLD SDMA ELISA.