Skip to main content

ASHG's Draft Policy on DTC Genetic Tests; A Primer for Vendors, Gov't, Docs, and Patients

Premium
On Oct. 10 during its annual meeting in New Orleans, the American Society of Human Genetics unveiled a draft policy statement on direct-to-consumer genetic testing.
 
The document, written by the group’s Social Issues Committee, offers suggestions for DTC genetic testing companies, government regulators, health care providers, and patients.
 
As Kathy Hudson, chair of the Social Issues Committee, put it this week: “The goal here really is to encourage transparency on the part of the companies so that providers and patients can understand what they’re getting.”
 
The group plans to post the entire document on its web site this week, at which time it will be open for public comment.
 
According to a copy of the draft statement ASHG provided Pharmacogenomics Reporter, in order for consumers to “make informed decisions” about DTC genetic testing, companies selling these tests “must provide all relevant information about offered tests in a readily accessible and understandable manner.
 
For example, companies offering DTC genetic testing “should disclose the sensitivity, specificity, and predictive value of the test, and the populations for which this information is known, in a readily understandable and accessible fashion.”
 
They should also “disclose the strength of scientific evidence on which any claims of benefit are based, as well as any limitations to the claimed benefits,” according to the draft statement. “For example, if a genetic mutation is a marker for disease or heightened risk of disease for only a small subset of those suffering from the disease, then the company should limit any claimed benefit to that population.”
 
DTC shops should also “clearly disclose all risks associated with testing, including psychological risks and risks to other family members” and “disclose the CLIA certification status of the laboratory performing the genetic testing.”
 
Finally, companies selling DTC tests “should maintain the privacy of all genetic information and disclose their privacy policies,” the ASHG suggests.
 
As for the federal government, the ASHG suggests that CMS ”should issue a proposed regulation for a genetic testing specialty under CLIA” and “ensure that all DTC genetic testing laboratories are certified under CLIA and should maintain a publicly accessible list containing the certification status of laboratories.”
 
In addition, the group said the federal government “should take steps to ensure the clinical validity of DTC tests making health-related or health-affecting claims” and “take action against those that make false or misleading claims about DTC tests.”
 
More specifically, it said the US Food and Drug Administration and the Federal Trade Commission should “work together to develop guidelines for DTC testing companies to follow to ensure that their claims are truthful and nonmisleading and adequately convey the scientific limitations for particular tests.”
 
In its tips for health care providers, the ASHG suggests they “should be educated regarding the types of genetic tests offered DTC, and counsel their patients regarding the potential value and potential limitations of DTC testing.”
 
For consumers, the ASHG says “the safest approach” is for the buyer to beware.

 
 

Filed under

The Scan

US Supports Patent Waivers

NPR reports that the Biden Administration has announced its support for waiving intellectual property protections for SARS-CoV-2 vaccines.

Vaccines Versus Variants

Two studies find the Pfizer-BioNTech SARS-CoV-2 vaccine to be effective against viral variants, and Moderna reports on booster shots to combat variants.

CRISPR for What Ails You

The Wall Street Journal writes that CRISPR-based therapies could someday be used to treat common conditions like heart attacks.

Nature Papers Review Integration of Single-Cell Assay Data, Present Approach to Detect Rare Variants

In Nature this week: review of ways to integrate data from single-cell assays, and more.