Pathway Genomics greatly respects and shares the FDA’s concerns about patient safety. We have received a letter from FDA, dated September 21, 2015, requesting certain information regarding the Pathway Genomics CancerIntercept™ Detect testing service. We are carefully considering the concerns of the FDA as stated in their letter, and we will be responding to that letter. We assure that there is physician involvement in the ordering, review and follow-up of CancerIntercept™ testing. We believe that CancerIntercept™ Detect is a laboratory developed test and, as a CLIA and CAP certified clinical laboratory, we are offering it as such. While Pathway Genomics is involved in educating and marketing the tests to physicians and consumers, we do not believe this is a direct-to-consumer model. We believe we have performed appropriate validation of the test as a laboratory developed test, and we are in the process of performing additional studies.
SAN DIEGO, Apr 29, 2015 — Mandy Kenyon, MS, RD, CSSD, is Pathway Genomics’ Registered Dietitian and played a major role in developing the customized diet plans that are part of tests such as Pathway Fit. Mandy is available to answer nutrition- and diet-related questions for Pathway’s clients and customers—contact her at email@example.com.
Mandy recently shared a couple of the most common questions she receives in her work as a dietitian, as well as her responses:
Q: I have a healthy diet, no history of heart disease in my family, and I am overweight but not obese—do I really need to exercise?
A: Absolutely. Being overweight (a BMI of 25.0–29.9) can have consequences, such as an increased risk of coronary heart disease, high blood pressure, stroke, and type II diabetes. Exercise can reduce these risks, and may improve both your current and future health by lessening the chance of complications later on.
SAN DIEGO, Apr 17, 2015 — Leslie Ordal, M.Sc., a field genetic counselor at Pathway Genomics, answers some frequently asked questions:
Are all genetic changes harmful?
No. In fact, everyone has genetic changes – it’s why we’re all different. Some genetic changes, called pathogenic variants, can be harmful to an individual, and in some cases, to their children if passed down.
Many other genetic changes; however, are quite common and have no known effect on health – we call these benign variants, and they’re just part of natural human variation. Some genetic changes can even be beneficial, such as those associated with reduced risk for certain diseases like Alzheimer disease.
By Michael Nova, M.D.
Chief Innovation Officer
There has recently (2013-15) been a flurry of human clinical trial publications regarding gene-diet interactions, primarily concerning obesity and related phenotypes.
A new finding by the Genetic Investigation of Anthropometric Traits, or GIANT, consortium has identified 97 gene regions associated with obesity, tripling the number of such genes previously known.
SAN DIEGO, CA – OCTOBER 13, 2014 – What is a genetic counselor and what does a genetic counselor do at Pathway Genomics? From the outside you would think that answering this question would be a simple task for someone who has spent more than 20 years providing clinical genetic counseling in a wide variety of circumstances such as prenatal, neurogenetics, hematology, and cancer genetics. Genetic counselors are a fiercely protective and private lot when it comes to our clients and our profession. Who we are and what we do are intimately intertwined.
SAN DIEGO, CA – October 2. 2014 – Genetic testing provides the opportunity to gain all sorts of insight–from the potential to diagnose rare diseases, to providing targeted therapies, to prevention. Although we have historically focused on the use of genetic testing for diagnosis, less attention has been given to genetic testing’s clinical use in preventing disease and managing health.
In the US, only 2% of the population has ever undergone genetic testing. However many studies show that the majority of patients and physicians believe that genetic testing is on the rise and that a significantly higher portion of the population could benefit from genetic testing to help identify risk for and even diagnose preventable conditions.