SpectraCell Laboratories has officially been granted a license to provide its Lipoprotein Particle Profile™ (LPP™) test, which assesses cardiovascular risk, to New York state physicians and patients. The recently patented LPP™ test has been commercially available to the other 49 states since 2006.
SpectraCell began the process of acquiring a licensure in 2008 with an application submission the state of New York. The laboratory underwent an initial inspection by the New York State Department of Health in late 2009 followed by extensive documentation validating the LPP™ procedure, which is standard protocol required of all diagnostic laboratories. A final inspection in December 2010 concluded the evidentiary process, proving the LPP™ technology is valid, accurate and reproducible.
“Acquiring our New York license allows us to serve the largest metropolitan area in the country,” states Dr. Fred Crawford, PhD, VP of Operations and Laboratory Director at SpectraCell Labs. “In fact, many physicians in the state of New York have wanted to implement the LPP™ test in their practice but were unable to do so until now. Plus, we recently streamlined our LPP™ report using feedback from existing LPP™ clients, making it easier than ever for physicians to translate LPP™ results into clinical decisions.”
New York represents a large market for laboratory testing. According to a CNN report, approximately 40,000 physicians practice within a 30 mile radius of New York City, in contrast to a national average of about 8000 physicians for other American cities.
After visiting the laboratory and reviewing the testing protocol, Dr. Robert Rej, Director of Chemistry for the State of New York Department of Health recommended the permit be approved for SpectraCell’s LPP™ testing. The license also allows SpectraCell to add FDA approved chemistry procedures to New York clients. Their first addition will be LpPLA2 testing (lipoprotein-associated phospholipase A2) which measures a specific enzyme linked to thrombosis (blood clots), indicating a higher risk of heart attack or stroke.
Just a few months ago, SpectraCell Laboratories was awarded a patent on their Lipoprotein Particle Profile™ (LPP™) test, which measures both the size and number of lipoproteins rather than the cholesterol contained within them. In recent years, more doctors have seen standard cholesterol tests label a patient “normal” when in reality their risk for heart disease is quite high.
In fact, The National Cholesterol Education Program (NCEP) acknowledges that 50% of people that have heart attacks have “normal” cholesterol – that is, cholesterol below 200 mg/dL. The LPP™ test allows physicians to stratify risk more accurately, thus prescribing therapies that will be the most effective, depending on their patients’specific lipid profile.
NCEP recognizes four risk factors that are not measured with routine cholesterol testing but are all measured by the LPP™ test:
- RLP – (remnant lipoprotein) more easily converted into arterial plaque than other lipoproteins
- Lp(a) – a dangerous lipoprotein that contributes to clot formation
- HDL2b – a type of HDL that indicates how well cholesterol is being cleared from your system
- Small, dense LDL – easily penetrates vascular wall, causing damage and plaque
The LPP™ is part of the trend toward more individualized medicine. The LPP™ test, which is done on a fasting blood sample, is usually covered by insurance. Results typically take 3-5 days.
Stop by our booths in New York City!
We will be at Booth #28 at the National Lipid Association (NLA) Scientific Session (May 19-22, 2011) and Booth #435 at Pri-Med (June 16-18, 2011)!