Article Response: Customer Commitment
Orig3n is part of a group of peer companies in the consumer genetics industry. Our goal is to democratize access to genetic information by empowering consumers with valuable information about their genetic blueprint, so that we can all be proactive about managing our wellness and, hopefully, improving our quality of life. As with most emerging technologies, there are naysayers, alarmists and detractors that disparage the companies, like ours, that are offering information to the public, because they don’t want consumers to have this information.
A recent article published by Bloomberg reports assertions from some former Orig3n employees that Orig3n’s laboratory is not managed under CLIA. Orig3n wholeheartedly disputes these assertions on a number of grounds. First, as the article notes, many of the claims that were made concern a period prior to November of 2017, when Orig3n had not yet acquired its CLIA laboratory. Second, Orig3n had to change many of its laboratory staff precisely because they simply wanted to “do things their way”, rather than in compliance with CLIA. Third, several claims are unsubstantiated by Bloomberg, despite our request for concrete evidence, and we are therefore unable to respond substantively.
Since November of 2017, Orig3n has performed all genetic testing in its Boston laboratory under the Clinical Laboratory Improvement Amendments (CLIA), as required by the U.S. Food and Drug Administration and administered in part by the Center for Medicare and Medicaid Services (CMS). CLIA is a federal regulation that was enacted to ensure quality in clinical laboratories.
This means that Orig3n’s laboratory, like all CLIA laboratories, is required to:
- Perform studies to validate that the lab is able to produce consistently accurate results.
- Perform periodic evaluations to ensure that its employees possess the necessary skills to properly operate laboratory equipment and interpret testing results.
- Employ a software system that traces every sample that it receives in the laboratory, from initial receipt in the lab, through processing and to final delivery of the test results.
- Employ a number of quality control measures to monitor and ensure the accuracy of day to day testing.
Orig3n does all of these things.
CLIA laboratories are certified by the states in which they sit (in our case, Massachusetts), and are also subject to periodic (including unannounced) audits. Orig3n’s laboratory has been audited and has continuously maintained CLIA certification since it originally acquired its CLIA laboratory in 2017.
Our technology for detecting and interpreting genetic results is based on technology that has been developed and advanced over several decades. This same technology is used in approximately two-thirds of labs performing genetic testing, and is widely considered the “gold standard” for genetic testing.
Recent advancements in understanding of the human genome have unlocked a plethora of applications, such as the genetic tests that Orig3n offers. The interpretations of the genes that we test are advanced by the scientific community on an ongoing basis as scientific understanding grows. All of our test results rely on, and refer directly to, studies published by the scientific community in scientific journals. Each of these publications is reviewed by our team of scientists before we include any gene in one of our tests. We continue to review new information as it is published, and to enhance our products with that information.
We believe that it is our responsibility to do the right thing at all times, and we strive to do that every day. Whether it be by assuring the accuracy and reliability of our testing, or promising that we will never share or sell our customers’ genetic results, we take that responsibility very seriously. Ultimately, actions speak louder than words.
We will stand with the courage of our convictions against those who oppose a consumer’s right to their own genetic information, because we believe strongly that we have an important and essential role to play in serving those who wish to learn more about what makes them who they are.
In an effort to address any concerns that our customers may have, Orig3n is offering to re-test samples that were processed in our lab prior to November 2017 for free. For current customers, we are offering to review any test with our laboratory staff, if there are any concerns about the results. All customer inquiries may be directed to firstname.lastname@example.org.
-Robin Y. Smith, Co-Founder, President and CEO