Color Genomics

Last updated
Color Health, Inc.
Color
Company type Private
IndustryHealthcare, Population health
FoundedApril 2015;9 years ago (April 2015) as Color Genomics
FoundersElad Gil, Nish Bhat, Taylor Sittler, and Othman Laraki
Headquarters
Burlingame, California
,
US
Area served
100+ Countries
Key people
Othman Laraki (CEO)
ProductsCancer risk, detection, and care, Population health programs, Medical research
Website color.com

Color Health, Inc. (founded as Color Genomics) makes population-scale cancer detection and care accessible, convenient, and cost-effective for employers, health plans, and unions. With nearly a decade of experience, Color has served millions of patients and partnered with innovators such as the National Institutes of Health, the CDC, large public health departments, and more.

Contents

Color’s cancer detection and management solution, built in partnership with the American Cancer Society, is a comprehensive, integrated care model that supports individuals from screening to diagnosis and care. Color provides risk education and assessment, accessible screenings, a nationwide clinical care network, and ongoing educational programming to help individuals and organizations take control of cancer.

History

Color booth at 2022 Carnaval San Francisco 2022 Carnaval San Francisco - 15.jpg
Color booth at 2022 Carnaval San Francisco

The company was co-founded in 2015 by Elad Gil, Nish Bhat, Taylor Sittler, and Othman Laraki, who is the CEO, [1] in Burlingame, California.

In November 2021, the company had a valuation of $4.6B and collected $100 million in a series E financing round. [2]

Expansion to population health

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

Color has partnered with health systems including NorthShore University Health System, [3] Ochsner Health System, [4] and Jefferson Health. [5]

COVID-19 testing programs

Color Covid-19 testing self-collection kit Color covid-19 self-swab collection kit - 3.jpg
Color Covid-19 testing self-collection kit

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. [6]

Color operates a high-throughput CLIA-certified COVID-19 testing laboratory and processes thousands of samples a day. The 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. [7]

In August 2020, Color was running some of the highest-capacity test sites in the country. [8] Color was also responsible for the majority of San Francisco’s COVID-19 testing with an average turnaround time within 24 hours, [9] and most results returned in under 48 hours. [10] Color worked with San Francisco’s CityTestSF program, [11] Alameda County Health Services [12] and federally qualified health centers in Alameda County, Marin County and others. [13] The company has also partnered with a wide variety of universities, employers and public health entities, including USC [14] and United Airlines. [15]

In January 2022, Color had computer difficulties that resulted in delayed test results and closed testing stations. [16]

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. [17] The test also identifies variants in 30 genes related to hereditary heart conditions as well as genes that may impact medication response. [18] 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. [19] 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. [20]

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, [21] 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. [22]

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.[ citation needed ] 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. [23]

In 2019, Color was named the sole awardee to deliver all of the genetic counseling for All of Us. [24] 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. [25]

Color Data, a database containing aggregated genetic and clinical information from 50,000 individuals who took a Color test, [26] 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. [27]

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. [28]

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. [29]

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. [30]

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. [31]

Color's research collaborators include: [32]

Related Research Articles

<span class="mw-page-title-main">Genetic counseling</span> Advising those affected by or at risk of genetic disorders

Genetic counseling is the process of investigating individuals and families affected by or at risk of genetic disorders to help them understand and adapt to the medical, psychological and familial implications of genetic contributions to disease. This field is considered necessary for the implementation of genomic medicine. The process integrates:

<span class="mw-page-title-main">Genetic testing</span> Medical test

Genetic testing, also known as DNA testing, is used to identify changes in DNA sequence or chromosome structure. Genetic testing can also include measuring the results of genetic changes, such as RNA analysis as an output of gene expression, or through biochemical analysis to measure specific protein output. In a medical setting, genetic testing can be used to diagnose or rule out suspected genetic disorders, predict risks for specific conditions, or gain information that can be used to customize medical treatments based on an individual's genetic makeup. Genetic testing can also be used to determine biological relatives, such as a child's biological parentage through DNA paternity testing, or be used to broadly predict an individual's ancestry. Genetic testing of plants and animals can be used for similar reasons as in humans, to gain information used for selective breeding, or for efforts to boost genetic diversity in endangered populations.

<span class="mw-page-title-main">Pharmacogenomics</span> Study of the role of the genome in drug response

Pharmacogenomics, often abbreviated "PGx," is the study of the role of the genome in drug response. Its name reflects its combining of pharmacology and genomics. Pharmacogenomics analyzes how the genetic makeup of a patient affects their response to drugs. It deals with the influence of acquired and inherited genetic variation on drug response, by correlating DNA mutations with pharmacokinetic, pharmacodynamic, and/or immunogenic endpoints.

deCODE genetics is a biopharmaceutical company based in Reykjavík, Iceland. The company was founded in 1996 by Kári Stefánsson with the aim of using population genetics studies to identify variations in the human genome associated with common diseases, and to apply these discoveries "to develop novel methods to identify, treat and prevent diseases."

<span class="mw-page-title-main">Personalized medicine</span> Medical model that tailors medical practices to the individual patient

Personalized medicine, also referred to as precision medicine, is a medical model that separates people into different groups—with medical decisions, practices, interventions and/or products being tailored to the individual patient based on their predicted response or risk of disease. The terms personalized medicine, precision medicine, stratified medicine and P4 medicine are used interchangeably to describe this concept, though some authors and organizations differentiate between these expressions based on particular nuances.

Genetic discrimination occurs when people treat others differently because they have or are perceived to have a gene mutation(s) that causes or increases the risk of an inherited disorder. It may also refer to any and all discrimination based on the genotype of a person rather than their individual merits, including that related to race, although the latter would be more appropriately included under racial discrimination. Some legal scholars have argued for a more precise and broader definition of genetic discrimination: "Genetic discrimination should be defined as when an individual is subjected to negative treatment, not as a result of the individual's physical manifestation of disease or disability, but solely because of the individual's genetic composition." Genetic Discrimination is considered to have its foundations in genetic determinism and genetic essentialism, and is based on the concept of genism, i.e. distinctive human characteristics and capacities are determined by genes.

Public health genomics is the use of genomics information to benefit public health. This is visualized as more effective preventive care and disease treatments with better specificity, tailored to the genetic makeup of each patient. According to the Centers for Disease Control and Prevention (U.S.), Public Health genomics is an emerging field of study that assesses the impact of genes and their interaction with behavior, diet and the environment on the population's health.

<span class="mw-page-title-main">23andMe</span> American personal genomics company

23andMe Holding Co. is a publicly trading personal genomics and biotechnology company based in South San Francisco, California. It is best known for providing a direct-to-consumer genetic testing service in which customers provide a saliva sample that is laboratory analysed, using single nucleotide polymorphism genotyping, to generate reports relating to the customer's ancestry and genetic predispositions to health-related topics. The company's name is derived from the 23 pairs of chromosomes in a diploid human cell.

<span class="mw-page-title-main">Stephen Hahn</span> American physician (born 1960)

Stephen Michael Hahn is an American physician who served as the commissioner of food and drugs from 2019 to 2021. Before becoming commissioner, he was an oncologist serving as chief medical executive of the MD Anderson Cancer Center. In 2021, he became chief medical officer at Flagship Pioneering, the venture capital firm that launched Moderna.

An Emergency Use Authorization (EUA) in the United States is an authorization granted to the Food and Drug Administration (FDA) under sections of the Federal Food, Drug, and Cosmetic Act as added to and amended by various Acts of Congress, including by the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), as codified by 21 U.S.C. § 360bbb-3, to allow the use of a drug prior to approval. It does not constitute approval of the drug in the full statutory meaning of the term, but instead authorizes the FDA to facilitate availability of an unapproved product, or an unapproved use of an approved product, during a declared state of emergency from one of several agencies or of a "material threat" by the Secretary of Homeland Security.

<span class="mw-page-title-main">Novavax</span> American biotechnology company

Novavax, Inc. is an American biotechnology company based in Gaithersburg, Maryland, that develops vaccines to counter serious infectious diseases. Prior to 2020, company scientists developed experimental vaccines for influenza and respiratory syncytial virus (RSV), as well as Ebola and other emerging infectious diseases. During 2020, the company redirected its efforts to focus on development and approval of its NVX-CoV2373 vaccine for COVID-19.

Clear Labs, Inc. is a private genomics testing company headquartered in San Carlos, California, United States. It offers a fully automated, next-generation sequencing (NGS) platform for turnkey diagnostics, including SARS-CoV-2 genomic characterization and detection of foodborne pathogens such as listeria and salmonella. It can also verify a food's ingredients, its GMO status, or conduct other tests.

Elective genetic and genomic testing are DNA tests performed for an individual who does not have an indication for testing. An elective genetic test analyzes selected sites in the human genome while an elective genomic test analyzes the entire human genome. Some elective genetic and genomic tests require a physician to order the test to ensure that individuals understand the risks and benefits of testing as well as the results. Other DNA-based tests, such as a genealogical DNA test do not require a physician's order. Elective testing is generally not paid for by health insurance companies. With the advent of personalized medicine, also called precision medicine, an increasing number of individuals are undertaking elective genetic and genomic testing.

Cathy Tie is a Canadian bioinformatician and entrepreneur, the founder of Ranomics, a genetic screening company, and of Locke Bio, a telemedicine company, both based in Toronto.

<span class="mw-page-title-main">Molnupiravir</span> Antiviral medication

Molnupiravir, sold under the brand name Lagevrio, is an antiviral medication that inhibits the replication of certain RNA viruses. It is used to treat COVID‑19 in those infected by SARS-CoV-2. It is taken by mouth.

Bamlanivimab is a monoclonal antibody developed by AbCellera Biologics and Eli Lilly as a treatment for COVID-19. The medication was granted an emergency use authorization (EUA) by the US Food and Drug Administration (FDA) in November 2020, and the EUA was revoked in April 2021.

Andrew Ira Brooks was an American immunologist, academic, and businessman. He was an associate research professor at Rutgers University and the developer of the first FDA-approved rapid saliva test for COVID-19 diagnosis.

Seegene, Inc is a Korean manufacturer of in vitro diagnostic (IVD) products, particularly molecular diagnostics. Its portfolio includes a range of assays and screening products for sepsis, respiratory diseases such as influenza and respiratory syncytial virus, as well as sexually transmitted infections (STIs). It was founded in 2000. In early 2020, it began developing and distributing a range of tests for SARS-CoV-2, the virus that causes COVID-19.

Bebtelovimab is a monoclonal antibody developed by AbCellera and Eli Lilly as a treatment for COVID-19.

References

  1. ↑ Rohrlich, Justin. "20 Minutes With: Color Genomics CEO Othman Laraki". www.barrons.com. Retrieved 2022-02-18.
  2. ↑ "Color valuation reaches $4.6B with vibrant $100M series E". www.bioworld.com. Retrieved 2022-02-17.
  3. ↑ "NorthShore Launches Complimentary Whole Genome Sequencing for 10,000 Patients". NorthShore University Health System. June 4, 2019.
  4. ↑ "Ochsner Health System to Pilot Genetic Screening Program in Partnership with Color". Ochsner Health System. October 18, 2019.
  5. ↑ Siwicki, Bill (October 24, 2019). "Jefferson Health combines genomics, population health to enhance employee wellness". HealthcareITNews.
  6. ↑ "Color is launching a high-capacity COVID-19 testing lab and will open-source its design and protocols". TechCrunch. Retrieved 2021-01-12.
  7. ↑ "This company has a better version of a simpler, faster Covid-19 test". STAT. 2020-08-06. Retrieved 2021-01-12.
  8. ↑ "Testing Demand Remains High In Bay Area". www.radio.com. 2020-08-31. Retrieved 2021-01-12.
  9. ↑ "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.
  10. ↑ "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.
  11. ↑ "Carbon Health and Color founders see power in bringing healthcare to the edge". TechCrunch. Retrieved 2021-01-12.
  12. ↑ "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.
  13. ↑ "Marin County considers $1.6M contract for virus testing". Marin Independent Journal. 2020-07-21. Retrieved 2021-01-12.
  14. ↑ "USC Student Health To Expand Daily Coronavirus Testing With Minimum 500 Daily Tests". 2020-07-30. Retrieved 2021-01-12.
  15. ↑ "United Airlines to be first U.S. airline with COVID-19 testing program for passengers". www.cbsnews.com. September 24, 2020. Retrieved 2021-01-12.
  16. ↑ "System outage sends patients home after thousands waited, some for 5 hours, to get tested for COVID". 11 January 2022.
  17. ↑ "Learn about the genes Color analyzes". Color.
  18. ↑ "Learn about the genes Color analyzes". Color.
  19. ↑ "Color receives FDA authorization for COVID-19 test tech that speeds up results". TechCrunch. Retrieved 2021-01-12.
  20. ↑ "FDA Gives EUA for At-Home COVID-19 Testing". Contagion Live. 27 July 2020. Retrieved 2021-01-12.
  21. ↑ "Color receives FDA authorization for COVID-19 test tech that speeds up results". TechCrunch. Retrieved 2021-01-12.
  22. ↑ "EMERGENCY USE AUTHORIZATION (EUA) SUMMARY FOR THE COLOR SARS-COV-2 RT-LAMP DIAGNOSTIC ASSAY". FDA. Archived from the original on 2020-05-31.
  23. ↑ "All of Us Research Program Overview". allofus.NIH.gov. 22 June 2020.
  24. ↑ "NIH funds genetic counseling resource ahead of million-person sequencing effort". National Institutes of Health News Releases. August 21, 2019.
  25. ↑ "FLOSSIES: A database of germline genomic variation in healthy older women". whi.color.com.
  26. ↑ "Explore Color Data to accelerate research". Color.
  27. ↑ "A scalable, aggregated genotypic–phenotypic database for human disease variation" (PDF). Database. 2019: 1–11. January 18, 2019.
  28. ↑ "About the MAGENTA Study". MAGENTA.
  29. ↑ "The WISDOM study compares annual mammogram to personalized breast screening". Wisdom. Archived from the original on 2019-10-31. Retrieved 2019-11-25.
  30. ↑ "The Gentlemen Study Pre-Screening Survey". The Gentlemen Survey.
  31. ↑ "Submitter". ClinVar.
  32. ↑ "A few of our research collaborators". Color.
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