Congress: Fix the BIOSECURE Act
Misinformation is behind the inclusion of Complete Genomics in the BIOSECURE Act, and it will result in harm to critical scientific research, higher costs, and a more entrenched market monopolist.
Facts prove that Complete Genomics should be removed from this legislation, and that there are better ways to protect American patient data.
Congress WRONGLY Includes Complete Genomics in the BIOSECURE Act
Complete Genomics and its parent company, MGI, do not belong in the BIOSECURE Act.
That bill aims to protect the genetic data of Americans, but these companies do not have access to or maintain personal DNA data as they manufacture instruments and do not provide sequencing services.
They also are not subsidiaries of BGI but rather separate companies with their own management, employees and assets. As such, Congress has wrongfully included Complete Genomics in this bill.
The facts are clear and simple: Complete Genomics is based in San Jose, California and offers the most cost-efficient and best performing gene sequencing equipment in the industry. From hospitals to labs to pharmaceutical and biotechnology firms, and all the way down to the patients they treat and save, the entire U.S. health care system stands to benefit from the DNA sequencers made and sold by Complete Genomics.
Congress: Fix the BIOSECURE Act now.
THE FACTS
Complete Genomics has no access to genetic patient data.
As a manufacturer of genomic sequencing instruments, but not a sequencing services provider, Complete Genomics does not have access to, collect, or maintain the genetic data of patients. Our customers own the data they produce, and they do not share or give Complete Genomics access to any data generated using our sequencers – which operate without connection to Complete Genomics servers.
In 2023, FTI Consulting validated the security of the Complete Genomics T7 sequencer and a separate ZTRON server used for local storage by customers. FTI concluded that Complete Genomics technology did not result in outbound, external IP communications during genomic sequencing, nor did our technology contain any concerning source code or network vulnerabilities.
Complete Genomics is NOT a subsidiary of BGI.
Although Complete Genomics was purchased by BGI in 2013 following approval from the Committee on Foreign Investment in the United States (CFIUS), it no longer is a subsidiary of BGI.
Rather, in 2019, Complete Genomics became a wholly owned subsidiary of MGI, a publicly traded company on the Shanghai Stock Exchange Science and Technology Innovation Board, commonly referred to as the STAR Market. MGI is also not a subsidiary of BGI, and BGI has no direct investment in MGI. It is a separate company with its own management, employees and assets.
About Complete Genomics
Complete Genomics is a San Jose, CA-based life sciences company offering advanced next generation DNA sequencing (NGS) instruments and platforms.
Complete Genomics has a long history in the U.S. market, serving as a research and development center of excellence since 2005. We have approximately 200 team members employed in the U.S.
Today, Complete Genomics’ instruments provide researchers and clinical labs with fast, cost-effective and accurate sequencing systems that have powered more than 6,500 research publications across a wide array of applications.
Complete Genomics is a wholly owned subsidiary of MGI, a publicly traded company on the Shanghai Stock Exchange Science and Technology Innovation Board, commonly called the STAR Market.
About the U.S. Genomic Sequencing Market
Genomic sequencing is the process of analyzing an organism’s genetic code to gain actionable insights, identify mutations and better understand the organism being sequenced – be it plant, animal, human or microorganisms like bacteria. This has many practical applications for disease prevention, early diagnosis and treatment, and even sustainable agricultural productivity and food yields.
The market for the manufacture of genomic sequencers in the United States is highly concentrated, with 80% of the sequencing market held by one company, Illumina. Illumina has also sought to increase its market share through other acquisitions too, some of which have been blocked by the FTC to prevent Illumina from becoming even more dominant.
Complete Genomics believes that a robust and competitive market best serves all interests, and that highly concentrated markets are bad for both customers and competitors alike by raising barriers to entry, driving up prices, and reducing incentives to innovate and find new treatments and cures.
The BIOSECURE Act: What People Are Saying
The BIOSECURE Act: CONSEQUENCES
Restricting Complete Genomics in the U.S. market is unwarranted and will have harmful impacts on U.S. researchers and laboratories, as well as patients and American citizens who can benefit from breakthrough research.
1. It is too narrow and fails to protect data.
It targets specific companies not the broader, vast market where personal genetic data of Americans is researched, stored, studied, and even sold. A law setting uniform privacy standards that apply to all companies would do a far better job of protecting personal DNA data.
2. It will concentrate the market, enshrine a monopoly, and drive up costs.
The already concentrated U.S. market for sequencers will become even more of a monopoly for Illumina – which already has roughly 80% of the genomics market. Monopoly levels of concentration drive up prices for customers, decrease customer choice, raise the barriers to entry for competitors and chill innovation, which is the major driver of this industry and its technologies.
3. Customers will suffer setbacks and face much higher costs.
Customers who are forced to rely on sequencers from competitors will face higher costs per gigabyte of data – sometimes twice as much – which will adversely affect U.S. genomic research, making it more expensive, reducing its volume and/or slowing it down – giving China and other countries a competitive advantage in genomic research.
4. It may contribute to drug shortages and slow down cutting-edge clinical trial research.
Other provisions of the BIOSECURE Act will slow down clinical trial research and require pharmaceutical manufacturing companies to find other sources of ingredients for their medicines. This will delay testing and production of promising new medicines, many of which are already in scarce supply. A BioCentury survey released in March found that 90% of biotech leaders said they expect U.S. pipeline delays if the BIOSECURE Act passes.
5. Industry opposes the BIOSECURE Act.
Taken together, these consequences help explain why a March 2024 industry poll taken by BioCentury found that just 18% support the BIOSECURE Act and more than half either oppose the legislation or expressed concerns about its impact on U.S. research and manufacturing capacity.
As reported in BioCentury on May 15, 2024:
The chairman of one of the largest U.S. molecular testing companies told BioCentury that CG equipment plays a critical role in making its services available to U.S. patients. The company, which did not want to be identified, reported that using CG equipment halves the cost of some of its products. Some of its molecular tests would not be economically viable if it had to rely on equipment from market leader Illumina Inc. because reimbursement rates would not cover the cost of conducting the tests, he said.
The company also said it has no concerns about security or privacy related to use of CG equipment because it has complete control over sequencing data. CG’s sequencers are not connected to the internet, and sequence data is stored separately from data that could identify an individual patient.
The BIOSECURE Act: SOLUTIONS
A more appropriate approach would look to other data-focused legislation and actions and take a similar, wide-ranging approach that applies to the most prominent holders of patient genetic data rather than targeting a very small subset of companies on the market.