Core Infrastructure

Lab Infrastructure

Color’s innovative laboratory technology and processes make us an extremely cost-effective option for genomic sequencing as part of a population health program. Our lab is CAP-accredited and CLIA-certified, and provides efficient and affordable data assets—from clinical, deep whole-genome sequencing, to research grade low-coverage WGS, and custom analytics.

Color’s lab generates sequence data with three primary goals: clinical-grade sequencing for clinically actionable genes, population-agnostic sequencing for statistical genetics, and raw sequencing data for desired option-value on future research or commercial applications. Our sequence output includes both targeted panel and whole genome sequencing (WGS) standard data sets.

Learn more about our Lab Licensing and Accreditation >

Clinical Reporting and Data

Color generates three sets of clinical reports based on the latest recommendations from professional health agencies and societies:

CDC Tier 1 Genomic Applications: 

The CDC named hereditary breast and ovarian cancer, Lynch syndrome, and familial hypercholesterolemia as Tier 1 genomics applications and estimates that nearly 2 million in the United States are at increased risk due to pathogenic or likely pathogenic variants. Several studies have found that population-level screening for these conditions leads to early detection and intervention, improved survival rates, and reduced cost.

 

ACMG Secondary Findings List:

In 2015 ACMG published a list of 59 clinically actionable genes that should be reported as incidental findings in clinical sequencing. These genes were carefully selected because they are associated with the more common genetic conditions and preventative measures are available.

Pharmacogenomics (PGx):

Recent studies have shown that approximately 90-99% of the United States population has at least one actionable variant in an established PGx gene. Color returns results for genes associated with a CPIC Level A gene/drug pair and with FDA-approved drug labeling.

Results are responsibly returned to participants through a HIPAA compliant process. All participants have access to Color’s genetic counselors and clinical pharmacists who can answer questions, help interpret results, and suggest next steps.

To ensure that clinically actionable results are acted upon by both clinicians and participants, Color integrates results back into existing clinical workflows. Individuals at increased risk for hereditary conditions, such as the CDC Tier 1 genomic applications, should be appropriately routed for high-risk participant management. Genomic results can be integrated back into the electronic health record (EHR) as discrete data fields. These data can then be used to populate best practice alerts which will ensure the proper integration of these types of results into the standard clinical flow.

Participant and Provider Workflows

Precision health and population genomics programs are comprised of a complex series of individual steps including participant engagement, consent, health data and history collection, genomic sequencing, data interpretation, return of results, genetic counseling, data integrations, and long-term care routing and engagement. To be successful, programs must make these individual processes connected and seamless for both participants, health care providers, and program administrators. 

Color’s flexible participant and provider workflow capabilities enable organizations to design and implement seamless programs that work for each organization. Whether you are looking to build a completely new end-to-end solution, or you are looking for a modular solution to augment and scale your current capabilities, Color can help you create the workflows to make your program successful. 

Can Color help make your program successful?

If you’re building or scaling a genomics or precision health program, we’d love to help.
Fill out the form below and a member of our team will reach out to you to discuss how we can help you reach your goals.