NCBiotech Launches DNA Testing/Counseling Pilot Project for Employees
The North Carolina Biotechnology Center has launched a demonstration pilot program of free genetic testing for its employees in a collaboration with health technology company Color Genomics.
NCBiotech employees choosing to join the program register to receive a test kit in the mail. They’re then asked to fill in an extensive online questionnaire about their own health histories and those of their family members. Participants then provide a saliva sample in a tube contained in the kit, and return it, postage prepaid, to experts at the Color lab.
-- photos courtesy of Color
After the lab’s analysis, one of the firm’s board-certified genetic counselors provides a confidential, one-on-one discussion of findings.
“It’s important that NCBiotech take this leadership position in the fast-unfolding field of precision health,” said Doug Edgeton, president and CEO of the Biotech Center, in announcing the optional employee program. “We have more than 170 companies statewide involved in some aspect of precision health, and this is an opportunity for the Center to show employers across the state how they can use this technology for everyone’s benefit.”
Color’s genetic screen is individually priced on the company’s website at $249, though the company says pricing can vary with different arrangements and packages. The NCBiotech package analyzes:
- Seven cancer-risk genes, looking for mutations that could increase the likelihood of developing hereditary breast, ovarian, colorectal, prostate and other cancers;
- Three genes associated with the hereditary heart condition familial hypercholesterolemia (hereditary high cholesterol) which can be treated with readily available medications; and
- 14 genes that determine how the body processes prescription medications, which the employees can share with their physicians to help inform dosing and medication choices to improve outcomes and reduce side effects.
Pilot project targets genes CDC designates Tier 1
Though Color’s labs are capable of analyzing more genes linked to health conditions, the designers of this pilot project targeted only genes that the U.S. Centers for Disease Control and Prevention (CDC) has designated as Tier 1. That refers to conditions that have garnered the highest levels of scientific evidence and are deemed “medically actionable.” In other words, someone with a mutation for one of these conditions can take action to prevent the disease, and/or detect it early to improve outcomes. Practitioners generally recommend against pinpointing genetic problems for which there are no treatments or solutions, to avoid creating unnecessary anxiety.
Participants will also be able to learn how their genes might influence other non-clinical traits, such as lactose intolerance.
“This is yet another area of precision health where North Carolina has a variety of leaders, assets and opportunities,” said Mary Beth Thomas, Ph.D., NCBiotech’s senior vice president of science and business development. “We’re hoping to engage employers across the state to help us bring this level of precision health innovation and opportunity to everyone who wants it. This is a valuable, cutting-edge healthcare opportunity that can be delivered to any North Carolinian with a mailbox.”
Thomas said the genetic counseling component is critical, to help participants get easy-to-understand expert advice on interpreting the results. Some of the increasingly popular at-home DNA testing services such as 23andMe have raised concerns that their data don’t include enough expert context, such as the professional consulting provided by Color.
The NCBiotech screening program is part of an innovative research pilot program available to all North Carolina employers called “cancer and hereditary disease management and pharmacogenomics population screening,” which is branded as CHAMPPS.
State precision health leaders, working together as the North Carolina Precision Health Collaborative, created CHAMPPS in response to recommendations from the National Academy of Medicine’s Genomics and Population Health Action Collaborative. The effort aims to identify and engage other employers around the state that share the vision of precision health, combining research data and “de-identified and aggregated” individual genetic information to ultimately improve health and reduce costs.
A chance to show NC employers, citizens how precision health can work
“The CHAMPPS pilot provides us the important opportunity to begin educating North Carolinians, whether they participate or not, about precision health, said Sara Imhof, Ph.D., NCBiotech’s senior director of precision health. “We want all our citizens to have a foundational understanding of this version of medicine and health care for the future.”
In recognition of Color’s commitment to genetic counseling and participant education related to genomic screening, the National Institutes of Health recently awarded Color a $4.6 million contract to support the NIH “All of Us” research program. Through this funding, Color’s network of genetic counselors will help participants understand what the genomic testing results mean for their health and their families.
Fewer than 10% of Americans who have treatable versions of inherited conditions related to cancer and heart disease are aware of their situation, according to the CDC.
“We hope that other North Carolina companies and organizations consider taking advantage of this investment in wellness and this unique North Carolina opportunity to engage in the homegrown CHAMPPS research pilot,” said Imhof.
In introducing the DNA testing program to NCBiotech employees, representatives of Color and NCBiotech emphasized that the free testing pilot project is voluntary and none of the data are shared with the Biotech Center or its health insurance provider. The federal GINA Act (Genetic Information Nondiscrimination Act) makes it illegal for health insurance companies to use any genetic testing information to affect coverage, including cost or availability.
However, the GINA Act does not apply to other forms of insurance, such as disability insurance, long-term care insurance, or life insurance. Providers of those types of insurances can, and some do, ask applicants whether they’ve received any genetic testing. Some states are creating protection laws as precision health awareness grows, but there is no nationwide mandate.
Business leaders anywhere in North Carolina who want to learn more can contact Imhof at (919) 549-8842 or sara_imhof@ncbiotech.org, or Jessica Tracy, director of enterprise at Color, at (610) 506-8896 or Jessica.tracy@color.com.