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Report: EU may hit Illumina with maximum penalty over Grail deal

Reuters reported this week that Illumina (Nasdaq:ILMN) may face a heavy penalty in Europe for completing its acquisition of Grail.

According to the report, the likelihood is that Illumina is penalized with a fine totaling 10% of its global annual turnover — the maximum penalty available. This comes as a result of the company closing the acquisition of Grail without European Union antitrust approval. Reuters cited “people familiar with the matter” in its report.

Reuters also said Illumina prepared $453 million to pay a potential EU fine with a plan to appeal against a penalty. The company believes its merger with Grail remains “pro-competitive” and in the best interests of patients worldwide, the report said.

The report stated that Illumina challenged the EU veto on the deal.

The history behind Illumina’s attempt to acquire Grail

The much-scrutinized acquisition of Grail, a cancer detection te…

Illumina is cutting 5% of its workforce

Illumina (Nasdaq:ILMN) announced that it commenced a headcount reduction totaling approximately 5% of its global workforce.

The company said yesterday that it is proactively realigning its core operating expenses in response to the current macroeconomic environment. It seeks to maintain its focus on its innovation roadmap and sustainable long-term growth, according to an SEC filing.

Get the full story at our sister site, Drug Discovery & Development.

Illumina is cutting 5% of its workforce

Illumina (Nasdaq:ILMN) announced that it commenced a headcount reduction totaling approximately 5% of its global workforce.

The company said yesterday that it is proactively realigning its core operating expenses in response to the current macroeconomic environment. It seeks to maintain its focus on its innovation roadmap and sustainable long-term growth, according to an SEC filing.

Earlier this month, Illumina reported its third-quarter 2022 financial results. That report included mentions of “challenging macroeconomic dynamics that we expect will continue into 2023.”

Illumina expects to incur a restructuring charge that also includes expenses associated with the optimization of its facilities. It plans to exclude this charge, which takes place in the fourth quarter of 2022, from non-GAAP financial metrics.

As of its Jan. 2, 2022, annual report, Illumina’s headcount totaled approximately 9,100 full-time employees. It also declar…

Illumina’s new NovaSeq X can sequence 20,000 genomes a year

[Image from Illumina]

Illumina (Nasdaq:ILMN) announced last week that it launched its new NovaSeq X series of production-scale sequencers.

San Diego-based Illumina said its new sequencers “push the limits of what is possible with genomic medicine.” NovaSeq X and NovaSeq X Plus offer faster, more powerful and more sustainable sequencing. The latter can generate more than 20,000 whole genomes per year.

At a clip about 2.5 times the throughput of prior sequences, this accelerates genomic discover and clinical insights, Illumina said. The company redesigned every dimension of its sequencers with what it calls revolutionary new technology to increase speed, scale, accuracy and sustainability.

The company launched a fundamentally new sequencing by synthesis (SBS) chemistry. Formerly known as Chemistry X and now called XLEAP-SBS, it engineered it for twice the speed and up to three times bette…

European Commission blocks Illumina’s Grail acquisition, company to appeal

Illumina (Nasdaq:ILMN) announced today that the European Commission issued a decision prohibiting its planned acquisition of Grail.

San Diego-based Illumina said it is reviewing the order and intends to appeal the decision. The new hurdle in Europe follows last week’s U.S. Federal Trade Commission ruling in favor of the acquisition moving forward. An administrative law judge in the U.S. rejected the FTC’s argument that the $8 billion acquisition of Grail is anti-competitive.

The much-scrutinized acquisition of Grail, a cancer detection technology developer, has met a series of roadblocks along the way. In September 2020, Illumina agreed to acquire Grail, a startup that initially spun out from the company in 2016.

Illumina completed the acquisition in August 2021. However, Illumina agreed to hold Grail as a separate company as the European Commission conducted a regulatory review. Illumina argued Grail has no business in Europe. The company said the…

Illumina clears antitrust hurdle related to merger with Grail

Illumina (Nasdaq:ILMN) announced today that an administrative law judge in the U.S. has rejected the Federal Trade Commission’s argument that the company’s $8 billion acquisition of Grail was anti-competitive.

More than a year after the deal closed, Illumina is still keeping Grail operating as a separate internal entity under a European Commission order. The EU investigation continues, with the company setting aside $609 million in legal contingencies during its second quarter in anticipation of a potential fine.

For now, Illumina has scored a legal win in the U.S. The FTC, like its European counterparts, had argued that the merger could hurt competition and innovation around multi-cancer early detection tests.

“Reuniting Illumina and Grail will transform the detection and treatment of cancer by facilitating widespread, affordable access to Grail’s life-saving Galleri test. This decision is a step toward making that vision a reali…

Illumina, Merck launch test for cancer development, progression insights

[Image from Illumina/Merck]Illumina (Nasdaq:ILMN) announced today that it launched a new research test, co-developed with Merck (NYSE:MRK).

The jointly developed test adds the assessment of a new genomic signature to the already distributed TruSight Oncology 500 assay, enabling researchers to unlock deeper insights about the tumor genome by identifying genetic mutations used in the evaluation of homologous recombination deficiency (HRD). HRD, a genomic signature, describes when cells are unable to effectively repair double-stranded DNA breaks, an occurrence that can lead to genomic instability and eventually tumor formation.

According to a news release, the new test will be made available globally, excluding the U.S. and Japan. The two companies originally announced that they partnered in September 2021 to develop and commercialize tests that identify genetic mutations used in the assessment of HRD.

“HRD status has emerged as an important biomarker …

Moody’s warns of cybersecurity, antitrust and supplier risks for medical device companies

[Image via Blogtrepreneur on Flickr, per Creative Commons 2.0 license]

Medical device companies face heightened cybersecurity burdens, antitrust enforcement and supplier risks, according to a new report out of Moody’s.

The research firm’s previous quarterly report in February called attention to continued supply chain and labor problems for medtech.

Below are the key highlights for medical device companies from the latest report.

Medical device cybersecurity

The report flagged legislative proposals for new rules and regulations on medical device developers and manufacturers, including new cybsecurity rules.

“The industry is ripe for increased oversight of cyber risks,” the analysts wrote in their report. “We have identified the sector as having a medium high exposure to cyber risk. And our survey of rated healthcare issuers indicates that medical de…

Medtech M&A: The industry’s biggest mergers and acquisitions of 2021

[Image from Jp Valery on Unsplash]

Across 2021, medtech has seen a wide range of mergers and acquisitions covering several areas of devices, pharmaceuticals and more.

Some have gone off without a hitch, while others fell into serious scrutiny as mouthwatering financial figures were revealed and major technologies were acquired.

Here are the 10 biggest mergers and acquisitions in medtech in 2021:

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Illumina may buy back Grail

Illumina (NSDQ:ILMN) may acquire Grail for more than $8 billion — four years after it spun out the cancer detection startup.

That’s according to a Bloomberg report out yesterday, which cited people familiar with the matter.

Analysts told Bloomberg that the acquisition would put Illumina — a giant in the DNA sequencing space — in direct competition with its customers. But the potential of Grail’s early cancer detection tech may be too good for Illumina to pass up.

Grail has been preparing for an IPO on the Nasdaq, where it would trade under the symbol GRAL. It plans to commercially launch its Galleri early cancer detection test next year.