California Enacts Genetic Privacy Legislation

On October 6th, California Governor Newsom (D-CA) signed SB 41 titled Privacy: genetic testing companies. The bill can be viewed here. Below are the highlights of the bill:

This bill would establish the Genetic Information Privacy Act, which would require a direct-to-consumer genetic testing company, as defined, to provide a consumer with certain information regarding the company’s policies and procedures for the collection, use, maintenance, and disclosure, as applicable, of genetic data, and to obtain a consumer’s express consent for collection, use, or disclosure of the consumer’s genetic data, as specified.

This bill would require a direct-to-consumer genetic testing company to honor a consumer’s revocation of consent in accordance with certain procedures, and to destroy a consumer’s biological sample within 30 days of revocation of consent. The bill would further require a direct-to-consumer genetic testing company to implement and maintain reasonable security procedures and practices to protect a consumer’s genetic data against unauthorized access, destruction, use, modification, or disclosure, and develop procedures and practices to enable a consumer to access their genetic data, and to delete their account and genetic data, as specified. The bill would exclude from its provisions the California Newborn Screening Program, specific tests, and certain information, providers, entities, and activities subject to specified state and federal laws.

This bill would provide that the act does not reduce a direct-to-consumer genetic testing company’s duties, obligations, requirements, or standards under any applicable state and federal law for the protection of privacy and security and would further provide, if a conflict exists between the act and any other law, that the provisions of the law that afford the greatest protection for the right of privacy for consumers shall control.

This bill would impose civil penalties for a violation of those provisions, as specified. The bill would require actions for relief pursuant to these provisions to be prosecuted exclusively by the Attorney General, a district attorney, county counsel, city attorney, or city prosecutor, as specified, in the name of the people of the State of California upon their own complaint or upon the complaint of a board, officer, person, corporation, or association or upon a complaint by a person who has suffered injury in fact and has lost money or property as a result of the violation of the act. Because the bill would require local officials to perform additional duties, the bill would impose a state-mandated local program.

Lanton Law is a national boutique law and lobbying firm that focuses on healthcare/life sciences and technology. 

If you are an industry stakeholder with questions about the current landscape or if you would like to discuss how your organization’s strategic initiatives might be impacted by either Congress, regulatory agencies or legal decisions, contact us today.

Illumina Acquires Grail

According to the press release, Illumina announced that it has “acquired GRAIL, a healthcare company focused on life-saving early detection of multiple cancers, but will hold GRAIL as a separate company during the European Commission's ongoing regulatory review. 

Illumina, the global leader in DNA sequencing, first announced its intention to acquire GRAIL nearly a year ago, reuniting Illumina with GRAIL four years after it was spun off. GRAIL's Galleri blood test detects 50 different cancers before they are symptomatic. Illumina's acquisition of GRAIL will accelerate access and adoption of this life-saving test worldwide.”  

This acquisition has been announced despite the fact that it faces a legal challenge from the FTC as well as European antitrust scrutiny. 

Here are the reasons Illumnia gave for the deal according to the press release:

• The deal will save lives. Cancer kills around 10 million people annually worldwide and 600,000 people in the US alone. Cancers responsible for nearly 71% of cancer deaths have no recommended early detection screening, and most cancers are detected when chances of survival are lower. Illumina feels there is a moral obligation to have the deal decided by a thoughtful and full review by the EU regulators and the US courts. This can only be done if Illumina acquires GRAIL now. Otherwise, the company is locked into a situation where the deal terms will expire before there is a chance for full review; the clock will just run out.

• Right now, the Galleri test is available but costs $950 because it is not covered by insurance. Reuniting the two companies is the fastest way to make the test broadly available and affordable. Illumina's expertise in market development and access has resulted in coverage of genomic testing for over 1 billion people around the world already. This experience will help lead to coverage and reimbursement for the Galleri test.

• GRAIL and Illumina have a long history. Illumina formed GRAIL and spun it out in 2016. GRAIL's first employees were part of Illumina, which still owns 12 percent of the company. GRAIL and Illumina are not competitors—this is a vertical acquisition.

• Based on past experience, when Illumina enters a market, the market expands. When Illumina entered the non-invasive prenatal testing space, prices dropped, reimbursement expanded, the number of providers increased, and more expectant parents had access to testing.

• Illumina's acquisition of GRAIL is driven by the belief that this test should be available to as many people as possible as quickly as possible. From fighting the COVID-19 pandemic to matching cancer patients to therapies, Illumina's mandate is to save lives and transform healthcare. The first COVID-19 viral sequence was on an Illumina machine and now genomic surveillance has emerged as a critical tool in the global fight against the pandemic, with over 70 countries now using Illumina platforms for COVID-19 variant tracking.

Lanton Law is a national boutique law and lobbying firm that focuses on healthcare/life sciences and technology. 

If you are an industry stakeholder with questions about the current landscape or if you would like to discuss how your organization’s strategic initiatives might be impacted by either Congress, regulatory agencies or legal decisions, contact us today.