Navigenics - Trustworthy results

The Navigenics Health Compass

At Navigenics, we take our responsibilities as pioneers in a new field very seriously. We aim to set high standards for this new kind of genetic testing, so you can trust our results and use them to live a longer, healthier life.

Genomics research is discovering strong correlations between single-letter changes in the genetic code (called SNPs) and the risk of many common, complex diseases such as cancer, diabetes and heart disease. Navigenics uses comprehensive whole-genome scanning technology — as opposed to the traditional approach of testing individual genes for individual conditions, one at a time — to screen for a number of these markers simultaneously.

As a Navigenics member, you submit a saliva sample, which is evaluated in a CLIA-certified lab, using a chip that scans the sample for approximately 2 million genetic markers across your genome. For each marker location, the chip reports whether your DNA contains zero, one or two copies of the genetic variations known to increase disease risk. For many conditions, we test multiple independent markers. This is not a diagnostic test, but an assessment of your estimated lifetime risk for developing these diseases or conditions.

The data derived from our scan could prompt you to seek diagnosis of conditions during their early stages as well as serve as a launching point for doctor-patient discussions about effective strategies to prevent, delay or reduce the symptoms of or stave off the progression of disease.

We pick conditions you can do something about

• We only test for actionable medical conditions: they can be prevented, detected early or treated. That means that while we show you your genetic risk, there is still opportunity for you to affect your overall risk by taking action.
• These conditions are relatively common, affecting more than 1 in 1,000 people. We may opt to include less common diseases that are more severe.
• Researchers have conducted complete genome scans for these conditions, minimizing the possibility that they might have missed a major genetic risk factor.

We select genetic markers based on strong science

In an exacting curation process, our team of Ph.D. geneticists selects risk markers that are significantly associated with clearly defined health conditions and that have been validated by multiple well-designed studies. We use the following guidelines for risk markers:

• The risk marker has an odds ratio (a measure of effect) greater than 1.15.
• The risk marker is found in at least 1 of 100 people in the general population.
• The effects have been reproduced in at least one other study on a similar group of people.
• If the effect of the genetic marker is small, then the study sample sizes are large enough to have sufficient statistical power for us to be confident of the results.
• Within a study, the comparison control group reflects a similar source population as the individuals with the condition.
• Data from the study was analyzed using sound statistical principles.
• Studies typically have been published in top-tier peer-reviewed journals such as Science, Nature and the New England Journal of Medicine.

We help you reduce your risk

Navigenics follows similarly rigorous standards for deciding which prevention and early detection measures to present to our members on our Web site. We know you want the most up-to-date advice, based on the strongest medical evidence, along with practical, action-oriented ways of applying that advice.

Prevention and early intervention strategies that we present to you on our Web site may include:

• Behavior modification
• Exposure reduction
• Medications
• Proactive screening
• Recognition of early symptoms
• Early treatment

We classify prevention measures into three categories:

• "Clinically proven" strategies have been shown, in repeated clinical trials, to prevent, delay or lessen the severity of the illness.
• "Promising" strategies have been shown to have significant positive effects in several clinical trials.
• "Preliminary" strategies have some support from population, animal or laboratory studies.

We use a CLIA-certified laboratory

We have tough standards for sample collection, shipping and processing. We use a CLIA-certified laboratory to do our processing. CLIA (Clinical Laboratory Improvement Amendments) are federal quality guidelines for laboratory testing standards. Our sample processing undergoes repeated quality checks and data verification procedures.

We validate your DNA against a reference group of 269 samples. We also compare your samples to the reference DNA on our test chip, which has been validated in thousands of experiments.

We boil it all down for you

Our science team has developed an index, approved by our scientific advisory board, which calculates your estimated lifetime risk of developing a disease based on your genetic markers. For more information about the factors and assumptions that go into the model, see How we estimate risk.