The Chinese government blacklisted several American companies, including gene sequencing-focused biotechnology firm Illumina Inc. and fashion brand PVH Corp., citing threats to China’s “national sovereignty, security and development interests.”
While the U.S. Supreme Court sidelined itself over patent issues such as subject matter eligibility, the diagnostic patent wars are still in full swing as a casual review of cases at the U.S. Patent and Trademark Office discloses.
The recent agreement between Devyser Diagnostics AB and Thermo Fisher Scientific Inc. to collaborate to obtain U.S. FDA approval for a next-generation sequencing (NGS) test for kidney transplant monitoring allows the test to be democratized, Fredrik Alpsten, CEO of Devyser to BioWorld.
The European Court of Justice declared that the European Commission was out of bounds in attempting to thwart Illumina Inc.’s proposed reacquisition of Grail Inc., which Illumina said relieves it of a fine of roughly €430 million (US$474.92 million).
Grail Inc.’s multi-cancer early detection test, Galleri, preferentially screens for aggressive prostate cancer, addressing concerns about overdiagnosis and subsequent overtreatment of indolent cancers, a study published in JCO Precision Oncology demonstrated.
Less than two months after the June spin-off of Grail Inc. (again), Illumina Inc. revealed a new strategy to cut costs and lift sales growth by focusing on the rapidly evolving multiomics space. Grail, meanwhile, unveiled its own plans to retool, going all in on multi-cancer early detection and cutting headcount 30%.
Illumina Inc. wasted no time in returning to the M&A front, closing the acquisition of Fluent Biosciences Inc. on July 9 with cash on hand, just a fortnight after freeing itself of Grail Inc. Fluent’s single-cell analysis technology expands Illumina’s presence in the life sciences, possibly marking a turn away from the diagnostics focus that led to the Grail debacle. The acquisition price was not disclosed.
The saga of Illumina Inc.’s attempt to reacquire Grail Inc., seems to have come to an end with a capitulation to market regulatory authorities, but Illumina has chosen to spin off Menlo Park, Calif,-based Grail rather than sell the company outright.
The U.S. FDA’s final rule for regulation of lab-developed tests was hardly a shock to the world of regulation, but the final rule might provide a shock for sorts for smaller entities in the diagnostics space. Analysts with Leerink Partners said most companies they routinely track are unlikely to be immediately affected by the final rule, but noted that FDA regulation might make it tougher for smaller, new entries to the space to get to market.
