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orig3n [2022/12/04 16:13]
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-===== Orig3n Inc ===== +====== Orig3n ====== 
-{{::orig3n_logo.png?200 |}}+ 
 +{{ ::orig3n_logo.png?200|}} 
 ==== History ==== ==== History ====
  
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 Smith, who has a background in scientific data management, has poured money into high-profile sponsorships and marketing events, setting up a demo test center where the 49ers play and becoming a headlining sponsor of San Francisco’s annual Bay to Breakers footrace. ((https://web.archive.org/web/20190911221532/https://www.bloomberg.com/news/articles/2019-09-11/dna-company-orig3n-tampered-with-results-former-employees-say)) Smith, who has a background in scientific data management, has poured money into high-profile sponsorships and marketing events, setting up a demo test center where the 49ers play and becoming a headlining sponsor of San Francisco’s annual Bay to Breakers footrace. ((https://web.archive.org/web/20190911221532/https://www.bloomberg.com/news/articles/2019-09-11/dna-company-orig3n-tampered-with-results-former-employees-say))
  
-=== Officers/Directors ===+==== Leadership Team ====  
 + 
 +((https://web.archive.org/web/20151025003932/http://www.orig3n.com/team/)) 
 +{{ ::origi3ns_leadership_team.png?600|}} 
  
 [[:Rene Oda]] - Director Product Management, Orig3n Inc ((https://www.bloomberg.com/profile/person/20428301?leadSource=uverify%20wall)) [[:Rene Oda]] - Director Product Management, Orig3n Inc ((https://www.bloomberg.com/profile/person/20428301?leadSource=uverify%20wall))
  
-Bahigh Acuna - General Manager - Direct To Consumer DNA , Orig3n Inc ((https://www.bloomberg.com/profile/person/20817354?leadSource=uverify%20wall))+[[:Bahigh Acuna]] - General Manager - Direct To Consumer DNA , Orig3n Inc ((https://www.bloomberg.com/profile/person/20817354?leadSource=uverify%20wall)) 
 + 
 +[[:James Lovgren]] - Chief Business Officer 
 +James Lovgren has a track record of commercializing disruptive technologies and managing global product portfolios in excess of $70MM. James joined ORIG3N from [[:Life Technologies]] (Thermo Fisher Scientific), where he built a robust stem cell portfolio and managed the **most successful [[:transfection]] product launch in corporate history**. He holds a BS in Biology from the [[:University of North Florida]] and an MBA from [[:North Carolina State University]]. 
 + 
 +[[:Jamie Metzl]] - Chief Strategy Officer  
 +Jamie Metzl brings a wealth of experiences to ORIG3N. He was a partner in the global investment firm [[:Cranemere]], and has served on the U.S. Senate Foreign Relations Committee, the [[:State Department]], & the [[:National Security Council]]. His books include the novel Genesis Code, which deals with issues around human genetic enhancement. He holds a PhD from Oxford, a JD from Harvard Law School, and a BA from Brown University. 
 + 
 +[[:Marcie Glicksman]] PhD CSO Consultant 
 +Dr. Marcie Glicksman has been in the drug discovery field for over 20 years, and has extensive experience in assay development, **high throughput screening, and chemical databases**. Before joining ORIG3N, she was **Co-Director** of the Laboratory for Drug Discovery in Neurodegeneration (LDDN), part of the [[:Harvard]] NeuroDiscovery Center. She holds a BA from Brown University and a PhD in Neuroscience from [[:Washington University]]. 
 + 
 +[[:Michael Fang]], MD, Chief Medical Officer 
 +Michael Fang is a physician and entrepreneur with a dual specialty in Internal Medicine and Geriatric Medicine. A founder of [[:CETA]], a **health information technology company**, he led the company in 1,500% growth over 3 years. In 2015, CETA ranked #297 on Inc. Magazine’s 5000 fastest-growing private US companies. Formerly, Michael co-founded [[:IMOSPHERE]], Inc. He holds a BA and a medical degree, both from Northwestern University. 
 + 
 +[[:Ken Levine]] VP Human Resources 
 + 
 +[[:Jish Mukerji]] 
 +Jish Mukerji comes to ORIG3N with over 15 years of experience in consumer marketing. For 9 of those years, Jish worked at [[:Apple]] as **Senior Marketing Manager for iPhone and iPad,** developing content strategies for national and international markets. Jish also has extensive product management experience in life sciences, and has worked in life science research and clinical diagnostics. He holds an MS from McGill University. 
 + 
 +[[:Shadrack Frazier]] VP Engineering ((https://web.archive.org/web/20210125212806/https://craft.co/orig3n/executives)) 
 + 
 +==== Honors ====
  
-=== Honors === 
 {{ ::orig3n_co-founders_robin_smith_and_kate_blanchard.png?400|}} {{ ::orig3n_co-founders_robin_smith_and_kate_blanchard.png?400|}}
-Our founders, Robin Y Smith, CEO and Kate Blanchard, COO were recently announced as Finalists in the **Ernst and Young Entrepreneur of the Year 2018 New England Awards** program. As the world’s most prestigious business award for entrepreneurs, we are so proud to be recognized as a leader at the forefront of the biotech industry.+Our founders, [[:Robin Y Smith]], CEO and [[:Kate Blanchard]], COO were recently announced as Finalists in the **Ernst and Young Entrepreneur of the Year 2018 New England Awards** program. As the world’s most prestigious business award for entrepreneurs, we are so proud to be recognized as a leader at the forefront of the biotech industry.
  
 Orig3n co-founders, Robin Smith and Kate Blanchard, bring a combined 35 plus years of experience to the groundbreaking regenerative medicine and consumer genetics industries. After previously working together for three years at Perkin Elmer after it acquired their last startup, [[:ArtusLabs]], Robin and Kate formed a remarkable partnership that is marked by ambition and dedication to social good.((https://web.archive.org/web/20210925021854/https://www.teloyears.com/blog/ey-blog-draft/)) Orig3n co-founders, Robin Smith and Kate Blanchard, bring a combined 35 plus years of experience to the groundbreaking regenerative medicine and consumer genetics industries. After previously working together for three years at Perkin Elmer after it acquired their last startup, [[:ArtusLabs]], Robin and Kate formed a remarkable partnership that is marked by ambition and dedication to social good.((https://web.archive.org/web/20210925021854/https://www.teloyears.com/blog/ey-blog-draft/))
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 ORIG3N is a biotechnology company, collects DNA samples and researches and develops treatments for genetically inherited diseases. ORIG3N is a biotechnology company, collects DNA samples and researches and develops treatments for genetically inherited diseases.
  
-Orig3n **helps people understand the links between their genes and how their minds and bodies work.** The company operates an online application for selling DNA test kits, collecting genetic samples for the research and development, and provides DNA results.+Orig3n **helps people understand the links between their genes and how their minds and bodies work.** The company operates an online application for selling [[:DNA test kits]], **collecting genetic samples** for the research and development, and provides DNA results.
  
  
-ORIG3N product portfolio includes LifeProfiles, a series of genetic tests comprising FITCODE that provides reports and insights on various aspects of fitness, including metabolism, muscle strength, endurance, joints, power performance, and exercise recovery; and AURA for assessment and insight on various aspects of skin, as well as Life Capsule, a blood cell repository for regenerative medicine development.  +ORIG3N product portfolio includes [[:LifeProfiles]], a series of genetic tests comprising FITCODE that provides reports and insights on various aspects of fitness, including metabolism, muscle strength, endurance, joints, power performance, and exercise recovery; and AURA for assessment and insight on various aspects of skin, as well as Life Capsule, a blood cell repository for regenerative medicine development.  
  
-ORIG3N's investors include Haitong International Securities Group Vectr Ventures, Spectrum Health Ventures etc. The company has acquired Interleukin Genetics in Nov 22, 2017 to date. ((https://web.archive.org/web/20210928042400/https://paganresearch.io/company/orig3n))+ORIG3N's investors include [[:Haitong International Securities Group Vectr Ventures]], [[:Spectrum Health Ventures]] etc. The company has acquired [[:Interleukin Genetics]] in Nov 22, 2017 to date. ((https://web.archive.org/web/20210928042400/https://paganresearch.io/company/orig3n))
  
  
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 === Dark Daily === === Dark Daily ===
 +
 +Oct 13, 2017 
 +
 +State and Federal Agencies Throw Yellow Flag Delaying Free Genetic Tests at NFL Games in Baltimore—Are Clinical Laboratories on Notice about Free Testing?
 +
 +Is it appropriate to offer **free genetic tests to 70,000 fans** attending a professional football game? Apparently not, say federal and state healthcare regulators who took steps to block a planned free genetic test giveaway that the Baltimore Ravens and clinical laboratory company Orig3n planned to conduct on Sunday, September 17.
 +
 +Genetic testing has become a mainstay of clinical laboratories and pathology groups. And it can’t be denied that the growing popularity of self-administered genetic tests could have an impact on medical laboratories’ revenue. Additionally, there’s the issue of state and federal privacy laws in the handling of protected health information (PHI) as outlined by the Health Insurance Portability and Accountability Act ([[:HIPAA]]) to consider. ((https://web.archive.org/web/20190813061055/https://www.darkdaily.com/state-and-federal-agencies-throw-yellow-flag-delaying-free-genetic-tests-at-nfl-games-in-baltimore-are-clinical-laboratories-on-notice-about-free-testing-1013/))
 +
 +
 +November 3, 2017 -
 +
 +This DNA Testing Company Is Violating Federal Lab Testing Rules
 +
 +Orig3n, the startup behind a controversial plan to collect football fans’ DNA, doesn’t have the legal certification to sell genetic health tests.
 +Stephanie M. Lee - BuzzFeed News Reporter
 +
 +Orig3n intended to give away genetic tests at a Baltimore Ravens game in September, but axed the promotion at the last minute in the face of questions from health officials. That led the [[:Centers for Medicare and Medicaid Services]] (CMS) to examine the tests that Orig3n sells online for as much as $149.
 +
 +At the time, the agency said it was working to determine whether Orig3n is subject to federal rules for laboratory testing of human samples. The company had privately argued that because it did not provide health information to individuals, it was exempt from those rules, known as the [[:Clinical Laboratory Improvement Amendments]] (CLIA).
 +
 +But in an Oct. 30 letter obtained by BuzzFeed News, a CMS official told Orig3n that it is, in fact, subject to CLIA rules because some of its tests — such as those purporting to assess customers’ athletic prowess and metabolism — measure people’s health. “To apply for CLIA certification, Orig3n must contact both the Massachusetts and California State Agencies immediately for guidance,” the letter said, referring to the states where Orig3n operates labs.
 +
 +Orig3n’s various tests **analyze 18 genes related to health**, from “muscle power” to “sugar sensitivity” to “age-related metabolism,” wrote Karen Dyer, a director in CMS’s division of laboratory services, in her letter to [[:Kate Blanchard]], Orig3n’s chief operating officer. “It offers genetic testing that provides information for the assessment of health.”
 +
 +Blanchard told BuzzFeed News that Orig3n’s products include 140 genes, and only 18 are subject to these federal rules. “We have been pursuing CLIA certification for some time,” Blanchard said in an emailed statement provided by a spokesperson. Until the company is certified, she said, Orig3n will keep selling tests that don't include those 18 genes.((https://web.archive.org/web/20190908075854/https://www.buzzfeednews.com/article/stephaniemlee/orig3n-is-not-clia-certified-government-says))
  
 Nov 8, 2019 Nov 8, 2019
 +
 17 Former Employees Accuse Orig3n of Clinical Laboratory Test Inaccuracies, Contamination, and Fabricated Test Results 17 Former Employees Accuse Orig3n of Clinical Laboratory Test Inaccuracies, Contamination, and Fabricated Test Results
 This is not the first time genetic-testing company Orig3n has been scrutinized by state and federal investigators over its business practices It’s not often that multiple employees of a clinical laboratory company go public with criticism about the quality of their lab company’s tests. But that is what is happening at Orig3n. Problems at the Boston-based genetic testing company were the subject of an investigative report published by Bloomberg Businessweek (Bloomberg).  This is not the first time genetic-testing company Orig3n has been scrutinized by state and federal investigators over its business practices It’s not often that multiple employees of a clinical laboratory company go public with criticism about the quality of their lab company’s tests. But that is what is happening at Orig3n. Problems at the Boston-based genetic testing company were the subject of an investigative report published by Bloomberg Businessweek (Bloomberg). 
  
 Jan 10, 2018 Jan 10, 2018
 +
 Federal Regulators Issue Notice to DTC Test Company Orig3n That Its Purchase of Interleukin Genetics Could Involve CLIA Compliance Issues ((https://web.archive.org/web/20220626170438/https://www.darkdaily.com/tag/robin-smith/)) Federal Regulators Issue Notice to DTC Test Company Orig3n That Its Purchase of Interleukin Genetics Could Involve CLIA Compliance Issues ((https://web.archive.org/web/20220626170438/https://www.darkdaily.com/tag/robin-smith/))
  
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 With headquarters near Vancouver, Canada, D-Wave U.S. is based in Palo Alto, California. D-Wave has a blue-chip investor base including [[:Bezos Expeditions]], BDC Capital, DFJ, [[:Goldman Sachs]], Growthworks, Harris & Harris Group, [[:In-Q-Tel]], International Investment and Underwriting, and Kensington Partners Limited. ((https://web.archive.org/web/20221203203024/https://www.sec.gov/Archives/edgar/data/893739/000114420416095161/v437452_ex99-1.htm)) With headquarters near Vancouver, Canada, D-Wave U.S. is based in Palo Alto, California. D-Wave has a blue-chip investor base including [[:Bezos Expeditions]], BDC Capital, DFJ, [[:Goldman Sachs]], Growthworks, Harris & Harris Group, [[:In-Q-Tel]], International Investment and Underwriting, and Kensington Partners Limited. ((https://web.archive.org/web/20221203203024/https://www.sec.gov/Archives/edgar/data/893739/000114420416095161/v437452_ex99-1.htm))
 +
 +==== Collecting DNA Selling Hope ====
 +{{ ::orig3n_2016_vice_banner.png?600|}}
 +Biotech Company Offers Fitness and Beauty-Focused Genetic Tests
 +Motherboard VICE - by Kari Paul - Jan 9 2016
 +
 +At the busy, crowded conference center where the Consumer Electronics Showcase was taking place in Las Vegas this week, dozens of people found time to roll up their sleeves and donate blood.
 +
 +The teaspoon-sized blood samples could create major changes in medicine in the future, according to Orig3n, the company collecting them for [[:stem cell]] research and consumer-facing genetics products.
 +
 +James Lovgren, Orig3n's chief business officer, said the company first started **soliciting blood samples in 2014** for its cell repository database of induced pluripotent stem cells (iPSCs), [[:LifeCapsule]]. The blood is collected and essentially reprogrammed into a stem cell-like state for research in [[:regenerative medicine]]. Orig3n has solicited thousands of donations from people at various events in the Boston area where it is based, partnering with organizations like the [[:Parkinson's Foundation]] to better understand the cellular and molecular foundations of disease.
 +
 +Those who donate also have an option to pay for access to their stem cells in the future. **For $99 a month, users can keep an insurance policy on their genetic health, storing cells in a living database in case they are needed as new cures are developed.** The immortalized cells could someday be retrieved, modified and then reimplanted into patients with diseases like diabetes.
 +
 +"People are already asking us **how they can integrate it into an app**," he said. "If you think about it, it goes right along with Fitbit or anything else—if you are trying to be healthier why not know your baseline health level?"
 +
 +Lovgreen added that it has been **surprisingly simple to convince people to donate blood**, even before they added the commercial kits. "People want to help because everyone knows someone who has been affected by one of these diseases," he said. 
 +
 +The LifeCapsule program is **sustained through partnerships with drug companies** for research. All donators sign an informed consent form giving Orig3n permission to take their blood, generate the stem cells, then use it in research, including with drug companies. ((https://web.archive.org/web/20181221032218/https://motherboard.vice.com/en_us/article/yp3dng/biotech-company-offers-fitness-and-beauty-focused-genetic-tests))
 +
 +==== COVID-19 Test Fraud ====
 +
 +Probe Finds Orig3n Covid Test Put Nursing-Home Patients at Risk
 +By Kristen V Brown, Bloomberg | 09. 08. 2020 
 +
 +Poor laboratory practices at a Boston company that performed [[:Covid-19 tests]] for dozens of nursing homes in Massachusetts put patients at risk of harm, state public-health officials said.
 +
 +On Friday, Bloomberg News reported  that the company, Orig3n Inc. was responsible for more than 300 **false-positive results at nursing homes across the state, spurring panic** at facilities already hard-hit by the pandemic and costing some tens of thousands of dollars.
 +
 +Orig3n, a consumer [[:DNA-testing]] company that pivoted to coronavirus screening, has faced scrutiny for laboratory issues in the past. Still, Massachusetts officials had recommended the company to long-term care facilities seeking to comply with mandatory surveillance-testing requirements. ((https://web.archive.org/web/20200922184558/https://www.geneticsandsociety.org/article/probe-finds-orig3n-covid-test-put-nursing-home-patients-risk))
 +
 +
  
 ==== ORIG3N Timeline ==== ==== ORIG3N Timeline ====
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 {{ ::orig3n_covid_testing_eua.png?400|}} {{ ::orig3n_covid_testing_eua.png?400|}}
-==== COVID-19 Testing EUA ====+==== COVID-19 Testing  Emergency Use Authorization (EUA) ====
 Breakthroughs in science have made it possible to discover the genetic traits that set someone apart.  Breakthroughs in science have made it possible to discover the genetic traits that set someone apart. 
  
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