California-based 23andMe is a genomics and biotechnology company. Its genetic testing service is highly regarded. The client provides saliva for SNP genotyping to ascertain ancestry and genetic health predispositions. named after the 23 chromosome pairs in a human cell
Since October 2015, DNA testing permitted by the FDA in the United States includes a health component. 23andMe began offering ancestry and health products in Canada and the United Kingdom in 2014. It began offering autosomal DNA testing for ancestry in 2007. 2008’s “Invention of the Year” was saliva-based genetic testing for consumers.
Linda Avey, Paul Cusenza, and Anne Wojcicki launched the company. The 2007 financial filings for 23andMe suggest a research database. In 2007, Genentech, NEA, and Mohr Davidow Ventures made investments. Wojcicki is the wife of Sergey Brin.
New genetic testing and the capacity to map huge portions of the human genome have created significant concerns, such as whether the results can be appropriately interpreted and may result in genetic prejudice. Companies that do genetic testing don’t know what the rules are, and risk-based rules haven’t been made yet.
In 2008, New York and California informed similar companies that they required CLIA approval to sell testing. August 2008 saw 23andMe obtain California approval.
Cusenza is the CEO of Nodal Exchange. In 2009, Avey co-founded Curious, Inc.
Company raised $50 million in a Series D investment in 2012. Financing in 2015 increased total to $241 million.
Gru spoke in the 2017 ad for 23andMe, while Buffett did so in 2018.
Wojcicki asserts that 23andMe has contacted the FDA since 2008. In 2010, the FDA notified genetic testing companies that their goods are medical devices that require approval. Illumina, the equipment and chip manufacturer, was also notified. In July and September of 2012, the company filed applications with the FDA.
In November 2013, the FDA designated genetic testing businesses that use equipment and chips for “research use only.”
Six months after failing to hear from 23andMe, the FDA ordered the company to discontinue promoting its saliva collection kit and personal genome service (PGS). The FDA is concerned about the public health consequences of inaccurate PGS results. The company ceased marketing PGS on December 2, 2013. Still available. Since December 5, 2013, 23andMe has solely sold genetic data and ancestry reports.
On November 25, 2013, company replied to media claims. “Our application does not meet FDA communication and timeline requirements.” We appreciate collaborating with the FDA and will address their concerns. ” The CEO of 23andMe updated the website: “The FDA and the company are pioneers.” Future businesses in this new market will benefit from our collaboration with the FDA; hence, the regulatory process is essential. It will guarantee the public that the science and processes of the service are secure.
In response to the FDA warning letter and regulatory evaluation, the company ceased offering health-related genetic testing to customers who purchased the test on or after November 22, 2013.
The company contemplated expanding to Canada, Australia, and the United Kingdom in May of 2014. 23andMe has been selling ancestry and health products in Canada and the United Kingdom since 2014. It submitted an FDA 510(k) application to commercialize a Bloom syndrome carrier test in 2014.
The application offers data validating the consistency and reliability of the company’s results and simple saliva collection equipment and instructions. It also included scientific evidence demonstrating that the company testing was associated with Blooms. In its permission statement, the FDA stated that future 23andMe carrier testing does not require equivalent applications. On October 1, 2015, the FDA clarified the test rules for 23andMe.
On October 21, 2015, 23andMe resumed market testing. “We did not comprehend the regulatory landscape,” Wojcicki said of FDA and CMS’s laboratory regulations (CMS).
23andMe submitted a “de novo” application for the commercialization of gene mutation tests to the FDA. Applications demonstrated the consistency and dependability of 23andMe The FDA approved eleven diagnostic tests in April 2017 for late-onset Alzheimer’s, Parkinson’s, celiac disease, hereditary thrombophilia, alpha-1 antitrypsin deficiency, glucose-6-phosphate dehydrogenase deficit, early-onset dystonia, factor XI deficiency, and Gaucher’s disease. In the future, the FDA will only approve genetic risk tests from 23andMe, not diagnostic tests.
In March 2018, the FDA authorized the company’s second de novo application for a direct-to-consumer (DTC) test for the three BRCA mutations most prevalent among individuals of Ashkenazi heritage. They are not the most prevalent mutations in the general population, and the test only detects three of the thousand known variants. These mutations increase the likelihood of breast, ovarian, and prostate cancer.
In September of 2017, the company secured $200 million at a valuation of $1.5 billion. The corporation raised a total of 230 million dollars.At $1.75 billion, $250 million was raised by the company.
July 25 saw the formation of a partnership between 23andMe and GlaxoSmithKline to study novel drugs utilising 5 million consumer test results. The company invested $300 million. In January 2022, GlaxoSmithKline paid $50 million to extend the contract through July 2023.
In 2020, 23andMe will eliminate 100 positions.
In July of 2020, 23andMe and GlaxoSmithKline began testing a cancer treatment.
The firm raised $82.5 million in December 2020, boosting its total to $850 million. After taxes, the value is uncertain.
In 2021, the company merged with VG Acquisition Corp., owned by Sir Richard Branson.
2021 was the expiration date. On June 17, 2021, 23andMe Holding Company began trading on Nasdaq under the symbol “ME.”
In 2021, 23andMe acquired Lemonaid Health for $400 million.