Release date: 2018-03-23
Recently, the US FDA announced that 23andMe has obtained the first direct-to-consumer cancer risk genetic testing authorization. After 23andMe's BRCA1 / BRCA2 Breast Cancer Genetic Health Risk Report was submitted, the FDA conducted an extensive evaluation of the consumer-grade gene product demonstrating high accuracy (more than 99% consistency with Sanger sequencing) and precision (greater than 99%) Reproducibility and repeatability data ensure that the product is safe and effective.
"The accuracy of the [HW1] genetic testing products currently available on the market is guaranteed at 99%. In essence, there is no technical difference between consumer-grade genetic testing products and common clinical and research-based genetic testing products." Director Wu Han said in an interview with the 21st Century Business Herald.
Founded in 2006, 23andMe's main product is a $99 personal genome product, which includes ancestral analysis and family relationship analysis. However, in recent years, its core strategy has gradually transformed from a consumer-level genetic testing service company to a big data company that provides research services for key drug research and development.
Data ownership dispute
The FDA's licensing door is not always open to personal genome testing, and 23andMe's products have been suspended.
In 2013, the FDA ordered 23andMe to discontinue selling its products, claiming that its sales of saliva collection kits and personal genome services were not licensed under the Federal Food, Drug, and Cosmetic Act.
However, the FDA has gradually recognized the rationality of consumer-grade genetic products: In February 2015, 23andMe was authorized by the FDA to launch the first direct-to-consumer genetic test for a genetically ill Bloom syndrome patient; in April 2017, 23andMe received FDA authorization to launch the first genetic health risk test for 10 diseases directly facing consumers.
But the controversy surrounding the consumer-grade genes has never stopped. "One of the biggest controversies lies in the ownership of genetic testing information. Some people think that the genetic testing that they decide is of little significance and must be guided by professionals. Others believe that genetic testing information is its own and should have the right to know. An investor in the genetics industry said that it seems that the FDA's attitude is to include it in regulation.
Although 23andMe's three products have been approved, the FDA's approvals remind consumers and health care professionals that the test results cannot be used to develop any treatment, including anti-hormone therapy and preventive breast or oophorectomy. In addition, the test does not provide information on the overall risk of a person suffering from any type of cancer. Individuals should not use the test results without consulting a doctor or genetic counselor.
Wu Han told reporters that technically, there is no barrier to entry in the consumer-grade genetic testing market. Therefore, the core value of a genetic testing company is the volume of data samples it possesses. "If the ability to interpret test reports is also excellent, this type The company has a promising future."
Cost performance is the key
Although the approved breast cancer risk prediction gene detection product was not approved in China, China's genetic company began selling it many years ago. Such as Huada Gene, Annoyouda and so on. However, almost all companies have relatively few sales.
In Wu Han's view, "China's medical environment still follows the tradition of medical practice, and there is not much interest in this type of product. Secondly, there is still a lack of mature business models in the market, including 23andMe." In the process of advancing the gradual maturity of consumer products, in addition to gradually cultivating consumers to rely on this type of products for high-throughput premarital testing and other fixed habits, it also needs the power of the Internet and commercial insurance companies.
Accuracy and high prices are one of the main reasons for the low interest of the public.
In terms of accuracy, such risk prediction products do not give consumers an accuracy value like the approved products such as NIPT; in terms of price, the reporter understands that each company's tests are around four or five thousand yuan. If it is a package, it is as high as 80-100,000 yuan. Such a high price makes potential customers discouraged.
In addition, there are differences in clinical and consumer products in terms of regulation.
The above-mentioned genetic industry investors further explained that from the form of products, clinical-level genetic testing is generally done by professionals, and is carried out under a completely supervised system. The regulation of consumer-grade genetic testing is relatively vague. And because it is aimed at a wide range of mass consumers including research laboratories, hospitals, individuals, etc., consumer-grade genetic testing is mostly carried out through the Internet of large consumption, or by new marketing means.
Although the business model is still immature, 23andMe is favored by capital. According to GeneMap's YourMap, 23andMe has received 10 financings totaling more than $700 million since its inception in 2006. Its investors are well-known capitals such as NEA, Google, J&J Development, and Sequoia Capital.
In this regard, the above-mentioned genetic industry investors said that on the one hand, there are not a few companies trying to do consumer-grade genetic testing, and 23andMe, which has survived and has been active all the time, has its own topic. On the other hand, its products can be launched at a price of 99 US dollars, and the high cost performance is definitely attractive.
Source: 21st Century Business Herald
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