23andMe, a popular direct-to-consumer genetic testing company, made headlines after its CEO pledged to help reunite the more than 2,300 children separated from their parents at the U.S.'s southern border.
23andMe co-founder and CEO Anne Wojcicki took to Twitter June 21 with an offer to donate DNA test kits to help reconnect affected families. Two days later, she shared more details on the company's plan of action, although the timeline for this effort is still unclear.
"To assist in reuniting families, we intend to offer our genetic testing services through non-profit legal aid orgs representing the families," Ms. Wojcicki wrote June 23. "We recognize that genetic data contains highly personal information and we want to ensure the data is only used for reuniting families."
The Mountain View, Calif.-based personal genomics company has sprung back from tumultuous times, hitting a roadblock in 2013 after the FDA issued a warning to the company, asking it to cease selling its flagship at-home DNA testing product.
However, since then, the company has become one of the most respected startups in the healthcare space — CNBC named the company No. 7 on its Disruptor 50 list in May and MIT Technology Review counted the company among its 50 Smartest Companies in 2017.
Here are 10 more things to know about 23andMe:
1. Anne Wojcicki, Linda Avey and Paul Cusenza founded 23andMe in 2006 to "help people access, understand and benefit from the human genome." The company's name references the makeup of human DNA, which is organized into 23 pairs of chromosomes.
2. Ms. Wojcicki, whose background comprises a decade in healthcare and biotechnology investing, serves as CEO of the company. Mr. Cusenza stepped down to helm electronic commodities exchange Nodal Exchange in 2008, while Ms. Avey went on to co-found the precision health startup Precise.Ly in 2011.
3. 23andMe has more than 5,000,000 customers across 50-plus countries. The company offers two flagship products, a $99 ancestry test and a $199 ancestry and health test. Both products are saliva-based DNA tests that do not require a blood draw. Customers order a test online, collect saliva with the at-home test kit and mail the package back to a 23andMe lab.
4. For the ancestry test, 23andMe analyzes segments of a customer's DNA to determine whether it matches the DNA of reference populations from 150-plus regions across Europe, Asia, the Americas, Oceania, the Middle East and Africa. The health test details whether a customer carries genetic markers associated with risks for select health conditions, such as celiac and Parkinson's disease.
5. In April 2017, 23andMe became the first company to offer FDA-approved direct-to-consumer tests that provide genetic risk information for various conditions after the agency authorized the company's at-home DNA tests for 10 diseases, including Parkinson's, Alzheimer's and rare blood diseases. In March, the FDA went on to greenlight 23andMe's test that reports mutations in BRCA1 and BRCA2 genes, which are linked to breast cancer.
6. The recent FDA approvals follow the agency's 2013 warning to the company, in which the FDA argued the company's marketing of its saliva collection kit and Personal Genome Service — the company's first product, which launched in 2007 — without FDA approval violated the Federal Food, Drug and Cosmetic Act.
7. 23andMe has since ramped up its focus on research, branding itself as "the leading consumer genetics and research company." More than 80 percent of 23andMe's customers have consented to participate in scientific studies, allowing the company to share genetic data with select researchers. In January, for example, 23andMe launched enrollment for a study on the underlying genetics of various depressive and bipolar disorders.
8. A major source of contention surrounding the company's direct-to-consumer genetic tests centers on whether customers are capable of interpreting their genetic risk reports without the help of a physician. Following the FDA's approval of 23andMe's test for BRCA1 and BRCA2 mutations, many physicians stressed patients should work with physicians or genetic counselors to interpret these test results alongside clinical context and family histories.
9. Ms. Wojcicki responded to these critics in an op-ed published in STAT, arguing patients should be trusted to interpret their own genetic risk reports. As part of her controversial opinion piece, she said recent critiques of the genetic tests were reminiscent of initial reactions to at-home pregnancy tests, which some physicians warned against when they first debuted in the 1960s.
10. 23andMe made headlines in May after filing a lawsuit against its top competitor in the direct-to-consumer genealogy space, Ancestry.com. In the lawsuit, 23andMe alleged Ancestry.com's AncestryDNA service — which boasts more than 10 million customers — infringed on its patented method for identifying a customer's relatives based on DNA samples and accused the company of misleading advertising.