An Open Letter to the Genomics Community from Complete Genomics

The Complete Genomics team remains grateful to our customers and partners whose trust allows us to deliver the most complete and cost-effective end-to-end genomic sequencing solutions.

Amidst the conversations happening in real time around proposed legislation, which is far from being enacted, including the BIOSECURE Act, which would restrict federally funded medical providers from accessing competitively priced genomic sequencing products, we want to be clear:

  • There is no basis for the inclusion of Complete Genomics in the BIOSECURE Act, and similar bills, and there is no current prohibition or restriction in force on the sale or purchase of Complete Genomics’ products. Customers can continue using – and acquiring – these products as they have previously.
  • Complete Genomics, founded and based in the U.S. for nearly 20 years, is a developer and manufacturer of genomic sequencing instruments. 
  • Complete Genomics is not a sequencing service provider and does not have access to, collect, or maintain genetic data. As you know our sequencers in your labs are not connected to our servers and none of your DNA data is shared with us.
  • Any information created or maintained using our sequencers is done by our customers who maintain sole control and responsibility for safeguarding the privacy of the data they generate. 

To emphasize the safety and security of our genomic sequencing instruments, we’re making public this report issued in October of 2023 by FTI Consulting, a U.S.-based global leader in cybersecurity: completegenomics.com/datasecurityreport

As evidenced by FTI’s report, which detected no outbound network traffic or external IP communications during DNA sequencing in operations relating to Complete Genomics’ flagship sequencer DNBSEQTM-T7, Complete Genomics does not access, collect, or maintain genetic data. The report also confirmed that no findings of “concerning source code or network vulnerabilities” and that the sequencer was “consistent with expected hardware design.”

In addition, some of our customers have independently evaluated data security on our sequencers and related equipment.  We welcome all customers and partners who wish to conduct their own assessments. We strongly support complete genetic data security.

Complete Genomics, a leading innovator in advanced sequencing employs more than 180 employees in the United States, including a highly professional U.S.-based field services team. This year, we will open a new US manufacturing facility in our San Jose headquarters and a customer experience lab in Boston’s biotech hub, further strengthening our commitment to American innovation.

Furthermore, contrary to what some have erroneously reported, Complete Genomics operates as a subsidiary of MGI, which went public in 2022. The two companies are independent with their own structure and governance; they are no longer subsidiaries of any other entity.

Drafted under the guise of national security, proposed bills like BIOSECURE would jeopardize our country’s national biosecurity by slowing our sector’s progress, stifling our innovation, and making it harder for researchers to make those important breakthroughs in areas like Alzheimer’s and oncology. As noted by the Biotechnology Innovation Organization (BIO) in a letter to lawmakers, these restrictions could also lead to delays in, or the termination of, ongoing health research projects, which could have implications for the development of cures and treatments of many diseases.

If the U.S. Congress seeks to protect genetic data, it should be done in a way that is equitable for all relevant parties. Complete Genomics supports protections for genetic patient data and believes there should be standards that apply consistently to all companies with access to this data, much like the Health Insurance Portability and Accountability Act (HIPAA), which already protects the healthcare data of individuals and applies to all parties that have access to such data. The BIOSECURE Act, unfortunately, will not accomplish this objective.

Sincerely,

Rade Drmanac, cofounder and CSO
Complete Genomics