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Color Genomics

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Color
Company typePrivate
IndustryPopulation Health, Biotechnology
FoundedApril 2015
FoundersElad Gil, Nish Bhat, Taylor Sittler, and Othman Laraki
Headquarters
Burlingame, California
,
USA
Area served
100+ Countries
Key people
Othman Laraki (CEO)
ProductsPopulation health programs, Genetic testing services, Medical research
Websitewww.color.com

Color is a population health technology company which provides genetic tests and analysis directly to patients as well as through employers. The product focuses on genes that indicate risk for heart disease, cancer, and that affect medication response.

History and Founders

The company was co-founded in 2015 by Elad Gil, Nish Bhat, Taylor Sittler, and Othman Laraki, who now serves as company CEO, in Burlingame, California.

Product Development

Prior to Color’s founding, clinical genetic testing was out of reach for most individuals, unless they had a significant personal or family history of hereditary disease. Testing used to cost $4,000, insurance had burdensome requirements for coverage, and even if insurance would cover the costs, testing often required multiple in-person visits, preventing people from learning information that could save their lives.[1]

Color’s product is a genetic test that costs $249, genetic counseling, and services for physicians.[2] The Color test analyzes 30 genes that highly impact risk for the most common hereditary cancers, 30 genes that impact risk for hereditary heart conditions and 14 genes that impact an individual’s genetic response to medications.[3]

Expansion to Population Health

Color provides technology, software, and clinical services for population health programs. Their services include:

  • Program strategy, planning, and implementation
  • Participant outreach and engagement
  • Participant education and consent about testing and results
  • Sample (blood or saliva) collection and genetic sequencing
  • Participant data management and clinical reporting
  • HIPAA compliance and data security
  • Return of results
  • Clinical services, like genetic counseling and clinical pharmacy
  • Personalized care routing
  • Ongoing population health management

Color has partnered with health systems including NorthShore University Health System[4], Ochsner Health System[5], and Jefferson Health[6].

COVID-19 Testing Programs

In early 2020, recognizing the growing threat that the COVID-19 pandemic presented, Color mobilized its existing software, logistics expertise and lab operations to focus on mass COVID-19 testing[7].

Color operates a high-throughput CLIA-certified COVID-19 testing laboratory and processes thousands of samples a day. The fully integrated process includes sign up, the self-collection kit, and results returned via text and email to patients, clinicians and public health authorities. Color returns results, on average, within 24-48 hours[8][9].

Color now runs some of the highest-capacity test sites in the country[10]. Color is responsible for the majority of San Francisco’s COVID-19 testing with an average turnaround time within 24 hours[11]. Nearly all results are returned in under 48 hours[12]. Color has delivered fast, convenient, and high-quality testing through partnerships with public health and government testing programs, including San Francisco’s successful CityTestSF program[13], Alameda County Health Services[14] and federally qualified health centers in Alameda County, Marin County and others[15]. The company has also partnered with a wide variety of universities, employers and public health entities, including USC[16] and United Airlines[17].

Testing System

Genetics

Color’s physician-ordered test can be initiated by individuals online, and a sample collection kit is sent in the mail. Individuals provide a saliva sample and return the kit in a pre-paid package. Color's CLIA-certified and CAP-approved lab analyzes for variants in the breast cancer genes BRCA1 and BRCA2, as well as 28 other genes associated with breast, prostate, colon, uterine, stomach, melanoma, pancreatic, and ovarian cancers.[18] The test also identifies variants in 30 genes related to hereditary heart conditions as well as genes that may impact medication response.[19] Genetic counseling with board-certified genetic counselors is available for free to all individuals who use Color.

COVID-19

Color’s FDA Emergency Use Authorization (EUA) COVID-19 test can be accessed as a part of testing programs initiated by a public health entity, university, employer or other organization[20]. The test is a dry anterior nasal swab, approved for use either in an on-site or at-home setting without the need for a healthcare provider to monitor sample collection, which eases the burden on the healthcare system and reduces testing costs[21].

The company has received an FDA EUA for the testing assay, which is a nucleic acid amplification method called LAMP, or loop-mediated isothermal amplification. This enables processing test results 50% faster than RT-PCR[22], the amplification method used at most other labs. LAMP relies on a different set of chemical reagents than standard PCR tests, which helps the process avoids supply chain scarcity[23].

Research

In 2018, Color was selected, alongside the Broad Institute of MIT and Harvard, and the Laboratory for Molecular Medicine (LMM) at Partners HealthCare, to establish one of three genome centers around the country for the National Institutes of Health’s historic All of Us Research Program.[24] All of Us will sequence one million or more people across the US, with the goal of accelerating health research and enabling individualized prevention, treatment, and care. The program has a focus on recruitment from populations that have been historically underrepresented in clinical science and genomic medicine, in order to build a diverse biomedical data resource that provides a foundation for better insights into the biological, environmental, and behavioral factors that influence health.[25]

In 2019, Color was named the sole awardee to deliver all of the genetic counseling for All of Us.[26] As the awardee, Color will customize software and tools to integrate data from all the genome centers, standardize reporting across the program, and ensure all results are returned in a unified way. This is a first year $4.6 million grant as part of a multi-year $25 million project.

In collaboration with the Women’s Health Initiative and Dr. Mary-Claire King at the University of Washington, Color provided genetic sequencing for the cohort of 10,000 Fabulous Ladies Over Seventy (FLOSSIES). This is the largest publicly available dataset of genetic variants associated with hereditary cancer in healthy, older individuals.[27]

Color Data, a database containing aggregated genetic and clinical information from 50,000 individuals who took a Color test,[28] helps researchers and scientists identify genotype-phenotype correlations and novel variants for functional analysis, as well as enables data-driven drug discovery and development. It is the largest public database of its kind.[29]

As a part of the MAGENTA Study, which aims to improve availability of genetic testing for hereditary cancer syndromes to at-risk individuals through the use of an online genetic testing service, Color is working with a Stand Up to Cancer Dream Team that includes physicians, scientists and researchers from the MD Anderson Cancer Center and the University of Washington to provide genetic counseling to high-risk individuals through delivery models such as tele-counseling.[30]

In collaboration with Dr. Laura Esserman at University of California and Sanford Health, Color is providing genetic testing for WISDOM, a 100,000-woman study that is comparing annual screenings with personalized, risk-based breast cancer screenings.[31]

As part of the GENtleMEN Study, Color is working with Dr. Heather Cheng at the Fred Hutchinson Cancer Research Center and the University of Washington to provide genetic testing and counseling to men with advanced prostate cancer.[32]

Color contributes anonymized variants to ClinVar, a free database managed by the National Center for Biotechnology Information (NCBI) at the National Institutes of Health (NIH) that helps researchers identify links between genes and disease.[33]

Color’s research collaborators include:[34]

References

  1. ^ Singer, Natasha (April 21, 2015). "Employees Jump at Genetic Testing. Is That a Good Thing?". The New York Times.
  2. ^ "New Product from Color Genomics Makes Comprehensive Genetic Testing for Breast and Ovarian Cancer Risk Affordable". Business Wire. April 21, 2015.
  3. ^ "Learn about the genes Color analyzes". Color.
  4. ^ "NorthShore Launches Complimentary Whole Genome Sequencing for 10,000 Patients". NorthShore University Health System. June 4, 2019.
  5. ^ "Ochsner Health System to Pilot Genetic Screening Program in Partnership with Color". Ochsner Health System. October 18, 2019.
  6. ^ Siwicki, Bill (October 24, 2019). "Jefferson Health combines genomics, population health to enhance employee wellness". HealthcareITNews.
  7. ^ "Color is launching a high-capacity COVID-19 testing lab and will open-source its design and protocols". TechCrunch. Retrieved 2021-01-12.
  8. ^ "Color CEO interviewed on CNN regarding employer COVID-19 testing - YouTube". www.youtube.com. Retrieved 2021-01-12.
  9. ^ "This company has a better version of a simpler, faster Covid-19 test". STAT. 2020-08-06. Retrieved 2021-01-12.
  10. ^ "Testing Demand Remains High In Bay Area". www.radio.com. 2020-08-31. Retrieved 2021-01-12.
  11. ^ "Why the time to get back COVID-19 test results in Bay Area ranges from 2 weeks to 2 days". SFChronicle.com. 2020-08-08. Retrieved 2021-01-12.
  12. ^ "Bay Area Covid-19 testing shows most have mild or no symptoms, younger people made up majority of cases". KTVU FOX 2. 2020-07-07. Retrieved 2021-01-12.
  13. ^ "Carbon Health and Color founders see power in bringing healthcare to the edge". TechCrunch. Retrieved 2021-01-12.
  14. ^ "Alameda County's new, free COVID-19 testing site seeks to 'increase access to testing in West Oakland'". KTVU FOX 2. 2020-06-02. Retrieved 2021-01-12.
  15. ^ "Marin County considers $1.6M contract for virus testing". Marin Independent Journal. 2020-07-21. Retrieved 2021-01-12.
  16. ^ "USC Student Health To Expand Daily Coronavirus Testing With Minimum 500 Daily Tests". 2020-07-30. Retrieved 2021-01-12.
  17. ^ September 24, CBS News; 2020; Am, 8:23. "United Airlines to be first U.S. airline with COVID-19 testing program for passengers". www.cbsnews.com. Retrieved 2021-01-12. {{cite web}}: |last2= has numeric name (help)CS1 maint: numeric names: authors list (link)
  18. ^ "Learn about the genes Color analyzes". Color.
  19. ^ "Learn about the genes Color analyzes". Color.
  20. ^ "Color receives FDA authorization for COVID-19 test tech that speeds up results". TechCrunch. Retrieved 2021-01-12.
  21. ^ "FDA Gives EUA for At-Home COVID-19 Testing". Contagion Live. Retrieved 2021-01-12.
  22. ^ "Color receives FDA authorization for COVID-19 test tech that speeds up results". TechCrunch. Retrieved 2021-01-12.
  23. ^ "EMERGENCY USE AUTHORIZATION (EUA) SUMMARY FOR THE COLOR SARS-COV-2 RT-LAMP DIAGNOSTIC ASSAY". {{cite web}}: line feed character in |title= at position 42 (help)CS1 maint: url-status (link)
  24. ^ "Color, Broad Institute and Partners LMM selected by NIH as Genome Center for historic 'All of Us' Research Program". PR Newswire. September 25, 2018.
  25. ^ "All of Us Research Program Overview". allofus.NIH.gov.
  26. ^ "NIH funds genetic counseling resource ahead of million-person sequencing effort". National Institutes of Health News Releases. August 21, 2019.
  27. ^ "FLOSSIES: A database of germline genomic variation in healthy older women". whi.color.com.
  28. ^ "Explore Color Data to accelerate research". Color.
  29. ^ "A scalable, aggregated genotypic–phenotypic database for human disease variation" (PDF). Database. 2019: 1–11. January 18, 2019.
  30. ^ "About the MAGENTA Study". MAGENTA.
  31. ^ "The WISDOM study compares annual mammogram to personalized breast screening". Wisdom.
  32. ^ "The Gentlemen Study Pre-Screening Survey". The Gentlemen Survey.
  33. ^ "Submitter". ClinVar.
  34. ^ "A few of our research collaborators". Color.
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