Boston Heart Diagnostics Introduces StatinSmart™

Personalized test helps identify likelihood of experiencing painful side effects from statin use

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Nov 19, 2015, 09:00 ET

FRAMINGHAM, Mass., Nov. 19, 2015 /PRNewswire/ -- Boston Heart Diagnostics today announced the launch of StatinSmart™, the first and only at-home saliva laboratory developed test that analyzes the SLCO1B1 (Solute Carrier Organic Anion Transporter 1B1) gene for a variant known to increase an individual's risk for developing statin induced myopathy—the onset of muscle aches, spasms and pain associated with statin therapy. StatinSmart™ helps patients understand how their bodies will process a statin and encourages them to discuss with their healthcare provider the type of statin that is best suited to their genotype. With this information, patients can work with their healthcare provider to personalize a plan to lower cholesterol without unnecessary side effects.

Boston Heart currently offers the SLCO1B1 genotype test through healthcare providers, but this is the first time this laboratory developed test will be offered directly to individuals online at statinsmart.com. All orders require physician authorization and include support for individuals to discuss their genotype result with their personal healthcare provider.

SLCO1B1 is one of the genes that instructs the enzymes that process statins in the liver.^1-4The SLCO1B1 genotype was identified at the University of Oxford in the UK. Boston Heart holds the exclusive U.S. license for the SLCO1B1 genotype test. To date, Boston Heart has performed over 250,000 SLCO1B1 genotype tests.

Although statins have been shown to significantly lower heart disease and stroke rates, studies estimate that of the 25-50% of patients with cardiovascular disease who stop taking their statin medications as directed, 60% cite muscle pain as the primary reason for discontinuation. A variant in the SLCO1B1 gene can cause the statin to not be fully processed, with the excess statin then moving through the blood stream into the muscles and causing pain. About 25% of the population has one or both variants, making them up to 4.5 to 17 times more likely to suffer muscle aches and pain.³

In a survey of individuals who have experienced side effects from statins in the past and have stopped taking them, 89% would consider taking statins again if they could potentially reduce the side effects.⁵ Research shows that patients who received SLCO1B1 genotype-guided therapy were more likely to fill their statin prescription, take the medication as directed, and ultimately lower their LDL cholesterol.⁶

"We're excited to bring our SLCO1B1 test directly to the consumer. Personalized medicine should be a critical piece of the process for managing cardiovascular disease—one in four people have risk of muscle pain on a statin, and this is the only commercially available genetic test to identify a patient's likelihood of experiencing this side effect," said Susan Hertzberg, CEO of Boston Heart. "We know that patients are struggling with managing the side effects of statin medications, and StatinSmart™ can help guide patients and their healthcare providers in selecting a treatment plan to lower cholesterol without suffering through the trial-and-error process of painful side effects."

StatinSmart™ includes an easy-to-use saliva kit and is shipped to the individual for collection then returned to Boston Heart's CLIA-certified and CAP-accredited laboratory in Framingham, MA for analysis. A personalized report and other information needed for individuals to prepare to discuss their result with their healthcare provider are accessible through a secure StatinSmart™ portal. StatinSmart™ is now available at statinsmart.com for the price of $99.00.

About Boston Heart
Boston Heart Diagnostics, a subsidiary of Eurofins Scientific (EUFI.PA), is transforming the treatment of cardiovascular disease by providing healthcare providers and their patients with novel, personalized diagnostics and integrated customized lifestyle programs that have the power to change the way clinicians and patients communicate about disease and improve heart health. Boston Heart looks beyond the "good" and "bad" cholesterol assessment that conventional labs provide to give a more complete picture of heart health. Founded by renowned cardiovascular researchers and led by seasoned lab and diagnostic executives, Boston Heart is one of the fastest growing health companies in the country. For more information on Boston Heart Diagnostics, please visit bostonheartdiagnostics.com.

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Voora D, Shah SH, Spasojevic I, Ali S, Reed CR, Salisbury BA, Ginsburg GS. The SLCO1B1*5 genetic variant is associated with statin-induced side effects. J Am Coll Cardiol. 2009;54(17):1609-1616.
Survey Methodology: The Boston Heart StatinSmart survey was conducted by Survata between May 28-June 22, 2015 via an online consumer panel of 1003 people with high cholesterol and who are on or have been on statins, ages 40-65.
Li JH, Joy SV, Haga SB, et al. Genetically guided statin therapy on statin perceptions, adherence, and cholesterol lowering: a pilot implementation study in primary care patients. J Pers Med. 2014;4(2):147-162.