An Update to the Genomics Community on the BIOSECURE Act

You may have seen that the House of Representatives Committee on Oversight and Accountability has voted to advance the BIOSECURE Act, which would restrict federally funded researchers and laboratories from accessing our leading, next generation genomic sequencing products. While we are disappointed that the committee has taken this step, we want to stress that this is just one step in the legislative process and does not mean the bill has become law. Customers can continue using – and acquiring – these products as they have previously, as there is still time to amend the bill to avoid harmful consequences to the genomic sequencing industry.

Also of note, the text of the BIOSECURE Act has been changed to extend through 2032, but that does not change the fact that Complete Genomics does not belong in the BIOSECURE Act in the first place.

According to the bill’s creators, one of the major goals driving the BIOSECURE Act is to protect personal DNA data from being shared for unauthorized or illicit purposes. As our customers know, we are a manufacturer of genomic sequencing instruments, not a sequencing service provider. Any information created by using our sequencers is maintained and controlled by our customers who have sole control and responsibility for safeguarding the privacy of the data they generate. Our sequencers are connected only to the customers’ servers. This is just one of the reasons that we do not belong in this legislation.

We have been open about the fact that Complete Genomics does not have access to, collect, or maintain the genetic data of patients, and we invite any skeptics to review the security of our products for themselves. In fact, former FBI cybersecurity experts at FTI Consulting have done just that. They assessed the security of Complete Genomics technology, including our flagship sequencer DNBSEQ-T7, and detected no vulnerabilities or capability to transmit data. The report confirmed there were no findings of “concerning source code or network vulnerabilities” and that the sequencer was “consistent with expected hardware design.”

Complete Genomics fully understands the imperative of protecting genomic data and will support approaches in the U.S. and worldwide that create reasonable, uniform standards for privacy that apply to all companies and parties with access to this data. Such an approach would protect sensitive DNA data, unlike the BIOSECURE Act which targets companies like ours and MGI that don’t have this data but omits companies that control the largest pools of this data.

While the bill’s primary genomics target is BGI, Complete Genomics is no longer a BGI subsidiary and is instead a subsidiary of MGI, which went public in 2022. Complete Genomics and MGI are separate companies from BGI, and have their own management, employees and assets. BGI has no direct investment in our company.

Complete Genomics remains committed to American innovation. We were founded in the United States and are based here to this day. We also are actively making new investments in America, including by opening a new U.S. manufacturing facility in San Jose and a customer experience lab in Boston’s biotech hub.

But this promise of innovation is in danger of being stifled because legislation like the BIOSECURE Act, that is driven by false assumptions about our access to genomic data and our company ownership, will have unintended consequences if enacted. As written, it would limit competition in the already-concentrated genomic sequencing market, which would stifle innovation, raise costs for scientists and labs and could even delay important research in areas like Alzheimer’s, oncology and food productivity. Additionally, it would deny U.S. researchers and labs access to the most efficient next generation sequencers available, giving a competitive advantage to those based outside the U.S. including in China.

We are grateful for the continued support of our customers and partners during this time, and welcome anyone who has questions or concerns about the BIOSECURE Act or our data security practices to reach out to us directly. Additionally, we encourage any of you who share our concerns to communicate them to your representatives and senators in Congress.

We will continue to keep you posted as there are further developments with the BIOSECURE Act.

Thank you for your interest and support.

Sincerely,

Rade Drmanac, cofounder and CSO
Complete Genomics