An administrative law judge has decreed that the acquisition of Grail Inc., by Illumina Inc., would not represent a suppression of competition in the market for multicancer early detection (MCED) tests, clearing a way for an acquisition that was initially valued at more than $7 billion.
The difficulty in resolving multiple rounds of patent litigation can foster a willingness on the part of both parties to settle their differences and go on their respective ways, which seems to be the end result of litigation between San Diego-based Illumina Inc., and subsidiaries of BGI Group of Shenzen, China. While Illumina is on the hook for a $325 million payout in this agreement, the company will receive a license to practice some of BGI’s affiliate’s patents, but the handshake also forecloses any further litigation over the disputed patents for three years.
Illumina Inc.’s acquisition of Grail Inc., of Menlo Park, Calif., may or may not prove to be a case of jumping the regulatory gun, but the move to date has not racked up significant financial penalties for the company. That may soon change per a statement by the European Commission, which said that Illumina may find itself on the receiving end of “hefty fines,” a statement made by EC executive vice president Margrethe Vestager.
Pillar Biosciences LLC hopes to build a stronger foundation for its multi-cancer in vitro diagnostic, Oncoreveal Dx. The company filed a supplemental application for U.S. FDA premarket approval of eight additional types of cancer, which the agency accepted for review. The assay received FDA premarket approval for use in non-small cell lung cancer (NSCLC) and colon cancer in August 2021.
Illumina Inc., of San Diego, is struggling to complete the regulatory side of its acquisition of Grail Inc., of Menlo Park, Calif., thanks in part to the U.S. Federal Trade Commission’s (FTCs) ongoing review of the transaction. However, Illumina is also facing stiff winds in Europe where the General Court of the European Union rejected the company’s bid to push the deal through despite the opposition of the European Commission (EC).
Companies in the device and diagnostics spaces are familiar with how government agencies react to acquisitions that bolster the acquiring company’s product pipeline, but vertical mergers provoke a different set of regulatory concerns. The European Commission (EC) recently updated its guidelines for vertical agreements, a development that could hamper some EU corporate activity going forward.
A new cancer genomic test co-developed by Illumina Inc. and Merck & Co. Inc. will soon be available globally, excluding the U.S. and Japan. The research use only Trusight Oncology 500 HRD test is designed to identify genetic mutations used in the evaluation of homologous recombination deficiency (HRD), a signal that can indicate tumor formation. The product combines HRD technology from genetic test maker Myriad Genetics Inc. and next generation sequencing (NGS) technology from Illumina.
A start-up rival to Illumina Inc. has emerged from stealth mode, debuting a new low-cost gene sequencing platform, the UG 100. Ultima Genomics Inc. has raised approximately $600 million from investors including General Atlantic, Andreessen Horowitz, D1 Capital and Khosla Ventures to scale development of the whole-genome sequencing, single-cell sequencing technology. Initial data using the platform to sequence more than 200 human genomes will be presented at the upcoming Advances in Genome Biology and Technology (AGBT) conference.
The lawsuit filed by Illumina Inc., against officials with Guardant Health Inc., revolves around trade secrets allegedly misappropriated by two former Illumina employees, including Helmy Eltoukhy, who helped to found Guardant while still employed at Illumina. Among other things, the complaint states that Eltoukhy had asked another Illumina employee about research that ultimately ended up in the hands of Guardant despite that the document in question was explicitly labeled as confidential and for internal use only.
Illumina Inc. and Agendia NV are joining forces for a multiyear partnership to develop diagnostic tests for breast cancer. The collaboration will unite lllumina’s Miseq Dx sequencing platform, with Agendia's flagship genomic test, Mammaprint, which identifies a patient’s breast cancer recurrence risk. Illumina has been steadily signing partnerships over the past few years and currently has more than 30 IVD partners and 40 sequencing-based solutions for cancer under development.
