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In Brief This Week: Illumina, Burning Rock Biotech, Real-World Evidence Alliance, and More

NEW YORK – The US Federal Trade Commission this week announced it will no longer pursue a preliminary injunction and temporary restraining order to prevent Illumina from consummating its purchase of Grail ahead of the planned administrative trial later this year. The FTC still seeks to block the deal on the grounds that it will harm competition in the nascent early cancer detection testing market.

"Now that the European Commission is investigating, Illumina and Grail cannot implement the transaction without obtaining clearance," FTC Acting Bureau of Competition Director Maribeth Petrizzi said in a statement. Therefore, she added, the preliminary relief sought in the US District Court for the Southern District of California is no longer necessary and the agency will seek to dismiss its complaint, to conserve both FTC and judicial resources. 

Illumina is mounting a legal challenge over the European Commission's jurisdiction to review the deal.

Burning Rock Biotech said this week that it has launched its PRESCIENT (Pan-Cancer Early-Stage Detection by Liquid Biopsy Technique Project) study, the first blood-based, pan-cancer early-detection study in China using a multiomics approach. The study, led by physicians Jie He and Jie Wang at China’s National Cancer Center, is expected to enroll 11,879 participants across 22 cancer types as well as healthy controls. The National Cancer Center will also work with other leading clinical centers, including Beijing Cancer Hospital, Jilin Cancer Hospital, and Hubei General Hospital.

Data and analytics firms Aetion, Flatiron Health, IQvia, Syapse, and Tempus joined this week to announce the creation of the Real-World Evidence Alliance to advocate the use of real-world evidence in biomedical regulatory decision-making. The RWE Alliance intends to engage policymakers, biopharmaceutical companies, medical device manufacturers, patient groups, and other industry stakeholders including trade associations to educate them about the benefits of real-world evidence.

Eurofins Scientific's Clinical Enterprise said this week that its EmpowerDx COVID-19 testing kit has received revised Emergency Use Authorization from the US Food and Drug Administration, for use with children 3 years of age and older. The kit is a PCR-based, at-home test for the detection of SARS-CoV-2 and is available without a prescription. Individuals 18 and older can self-collect using a shallow nasal swab included in the EmpowerDx testing kit, while individuals 13 and older can self-collect under adult supervision. Children 3 and older require an adult to assist with collection, Clinical Enterprise said. The samples are sent to CLIA-certified laboratories and results are delivered to a patient portal within 24 hours, on average.  

Roche Diagnostics this week announced a partnership with Canadian Blood Services to support a seroprevalence study to better understand the immune response to COVID-19. The study will compare the level of antibodies generated by SARS-CoV-2 vaccines and antibodies generated by natural infection. Canadian Blood Services will use Roche's Elecsys Anti-SARS-CoV-2-S and Elecsys Anti-SARS-CoV-2 serology tests to detect antibody levels.

Canada's COVID-19 Immunity Task Force has funded a long-term project to determine the extent of the SARS-CoV-2 infection in the country, and expects to collect more data on immunity in Canadians, seroprevalence of the virus in younger populations, seroprevalence rate disparities, relations between seroprevalence rates and socioeconomic disparities, vaccination strategies, and the speed of virus propagation through this study.

Sera Prognostics this week announced a strategic partnership with health insurer Anthem, whose health plans cover more than 10 percent of pregnancies in the US each year. Anthem will make Sera Prognostics' PreTRM blood-based biomarker test available to its pregnant members as part of a multiyear contract. PreTRM provides an early prediction of the risk for spontaneous preterm birth in asymptomatic singleton pregnancies.

The Access to Comprehensive Genomic Profiling Coalition said this week that it has added Mayo Clinic Laboratories to its members. Founded last November, the partnership of diagnostic firms and laboratory service providers advocates for broad health insurance coverage in the US of comprehensive genomic profiling for patients with advanced cancer.

Amazon announced this week that it has received accreditation from the College of American Pathologists for its diagnostics laboratory in Hebron, Kentucky. The lab provides Amazon employees with regular, free COVID-19 testing as part of the company’s in-house testing program. Amazon has also built a diagnostics lab in the UK, and the labs have processed millions of tests from more than 750,000 front-line employees, the firm said.

Thermo Fisher Scientific said this week that its board has authorized a quarterly cash dividend of $.26 per share, payable on July 15 to shareholders of record on June 15.

Agilent said this week that its board has approved a quarterly cash dividend of $.19 per share of common stock, payable on July 28 to all shareholders of record as of July 6.

Luminex this week announced a quarterly cash dividend of $.10 per share of common stock, payable on July 8 to stockholders of record on June 17.

In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared on GenomeWeb.