For Partners: Researchers & Clinical Trial Sponsors

Genetic counseling
built into your study.

Grey Genetics works with genomic researchers, academic PIs, and clinical trial sponsors, providing genetic counseling and consulting across all stages of a study.

How we support your study

Grey Genetics provides board-certified genetic counseling as a contracted service for research studies and clinical trials — adapted to your study design, participant population, and IRB framework.

Participant-facing services
  • Pre-test genetic counseling and education
  • Design of pre-test educational materials
  • Post-test results disclosure and guidance on next steps
  • Follow-up support for participants, as needed
Protocol support
  • Consulting on study and consent design
  • Participant-facing workflow design
  • Genetic test facilitation in all 50 states — through licensed GCs and, where needed, our third-party physician group
  • Written documentation after every participant encounter

Whether you're in the design phase or already enrolling, we're happy to discuss what genetic counseling support could look like for your study.

info@greygenetics.com

Clinical trials & targeted therapies

Precision medicine trials enrolling participants based on germline variants or genetic biomarker eligibility create a genetic counseling need most trial sites cannot reliably meet on their own. A participant identified as BRCA-positive, LRRK2-eligible, or a carrier of a heritable cardiovascular variant may be encountering that information for the first time — in the context of a clinical trial, without pre-test counseling, and without a genetics provider in their care team.

A genetic counselor takes a complete personal and family history, discusses the variant in that context, and helps the participant understand what the finding means for their own health and their family's — separately from what it means for trial eligibility. A genetic counselor also discusses the difference between a research result and a clinical genetic result. When findings are research use only and clinical testing is indicated, a genetic counselor can provide resources for participants who may want to pursue additional genetic testing, outside the study. Providing this type of high-touch, clinically meaningful support may also contribute to participant satisfaction and retention.


Academic studies & investigator-initiated research

Grey Genetics works with PIs at academic medical centers and research institutions who need a flexible, contracted GC partner that fits their study's scale and timeline. We work with studies of any size — from single-site investigator-initiated research to multi-center genomic studies.


Whole genome sequencing & secondary findings

Secondary findings are incidental results — variants unrelated to the primary study question, but medically actionable for the participant. When a study uses whole genome or whole exome sequencing, they are a near certainty: 1–6% of those sequenced carry a finding on ACMG's list of reportable secondary findings. A plan for returning them is increasingly expected by participants — and some studies have shown that offering return of results is associated with greater willingness to enroll.

Bioinformatics partners can flag possible secondary findings — but from there, each subsequent step requires clinical expertise:

→ Clinical triage of returnability in the context of participant age and study protocol
→ Considerations for future return of findings when minors become of age
→ Pre-test genetic counseling
→ Confirmatory testing facilitation
→ Results disclosure
From the literature

"It is no longer a question of whether or not results with clinical utility will be found in any research participant by ES/WGS, but rather how many such results will be identified in each participant."

Tabor HK, et al. Am J Med Genet A. 2011 Dec;155A(12):2916–24.

Thinking about returning secondary findings?

It doesn't have to be complicated — but it does require the right clinical infrastructure. If you're designing a WGS or WES study and wondering whether it's feasible for your protocol, we're happy to walk through what it could look like in practice.

info@greygenetics.com