Specialized FDA user comprehension consultants for consumer genomics

User comprehension is critical to authorization – and the future of genetic testing.
If genome sequencing is to become commonplace, an understanding of genomic concepts will be necessary for everyone involved. Evidence-based clinical guidelines, decision support tools, and user-friendly risk-stratification and prevention algorithms will be necessary to ease genome sequencing into mainstream medicine in a practical way.

Regulatory agencies often require data collection – such as an FDA user experience study, label comprehension study, self-selection study, and other evaluative or clinical studies. These needs fit perfectly within our consulting and data collection service expertise. Specifically, SoundRocket’s user comprehension study service is managed in-house by an expert team of genetic counselors, survey methodologists and research/data collection specialists who have experience in completing studies for medical devices that have successfully gained FDA approval.

Seeking help with FDA mandated data collection?

Consult with SoundRocket’s genetic testing experts to see how we can help you.

Experts in label comprehension, FDA premarket authorization, and other related studies are positioned to assist with:

Physician-ordered genetic testing where the manufacturer desires a high level of consumer comprehension (and that may pivot into the DTC space eventually)
Wellness or ancestry genetic testing companies adding a GHR or PGX product or desiring high comprehension of genetic concepts
Pharmacogenomic testing for medication management (both DTC and healthcare provider managed)

Direct-to-consumer (DTC) genetic testing services

Diagnostic genetic testing for all audiences (where comprehension is important)
Proactive genetic test panels marketed directly to patients
Companion diagnostic testing for genetically-targeted drugs
lighthouse beacon of light fda guidance label comprehension
Use prepare and collect

We have successfully navigated this path with multiple genetic test medical device manufacturers—resulting in FDA 510k clearance

Our FDA label comprehension studies use iterative, interview-based stages in the development and refinement of report contents and user comprehension questionnaire validity. We have also worked with NIH, NIDA, CDC, NSF, and NIAAA funding on multiple primary research studies.

Our primary research team engages with several academic research teams including PeopleSeq, pGen, and others on the topic of the social impacts of genetic testing. Our research collaborators in this area come from institutions such as Harvard University, the University of Minnesota, the University of Michigan, Jackson Laboratories, Duke University, among others.

Having worked with Ancestry.com, 23andMe, Oneome and others, SoundRocket understands the current needs and requirements around the U.S. Food & Drug Administration (FDA) regulatory pathways for Direct-to-Consumer (DTC) personal genetic testing, including:

Carrier Screening Tests (21 CFR 866.5940)

Genetic Health Risk (GHR) Tests (21 CFR 866.5950)

Pharmacogenetics Tests (21 CFR 862.3364)

including the 2020 follow-up (K193492)

Cancer Predisposition Tests (CFR 21 866.6090)

The next decade will revolutionize how humans interface with their genes. Helping to study this relationship and ensure that people understand is where we, at SoundRocket, come in.