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In Brief This Week: Exact Sciences, Siemens Healthineers, Seegene, Agilent Technologies, and More

NEW YORK – Exact Sciences said this week that it has completed its previously announced acquisition of Ashion Analytics. The acquisition of Ashion brings Exact a CLIA-certified and CAP-accredited lab, deep sequencing capabilities, and a comprehensive genomic cancer test called GEM ExTra to aid Exact in serving more patients across the cancer continuum, including therapy selection and minimal residual disease testing, the company said.

Exact also said that it is expanding its multi-year collaboration with the Translational Genomics Research Institute to further benefit from TGen and City of Hope's expertise in developing better advanced cancer diagnostics and establishing the clinical evidence necessary to support their adoption.

Siemens Healthineers this week said that it has completed its previously announced acquisition of Palo Alto, California-based Varian Medical Systems. Siemens Healthineers said that with Varian it will leverage artificial intelligence-assisted analytics to advance the development and delivery of data-driven precision care and redefine cancer diagnosis, care delivery, and post-treatment survivorship.

Seegene said this week that its Italian subsidiary, Arrow Diagnostics, will supply approximately 7.15 million COVID-19 diagnostic tests and extraction reagents to the Extraordinary Commissioner for COVID-19 Emergency under the Italian Ministry of Defense. The procurement is worth more than €89.3 million ($107 million), Seegene said. The COVID-19 tests will be distributed to 17 regions including Lombardy, Tuscany, Veneto, and Liguria. Seegene's COVID-19 Allplex SARS-CoV-2 Assay is a multiplex real-time PCR assay that can detect five target genes, including four viral genes (E, RdRP, N, and S) and an exogenous control, in a single reaction. The test received CE-IVD marking in June 2020.

Agilent Technologies said this week that it has completed its acquisition of Resolution Biosciences. Agilent believes the firm’s liquid biopsy-based technology will strengthen its offerings to biopharma and clinical diagnostic customers, as well as boost its diagnostic and genomics business.

Accelerate Diagnostics this week said it has entered into a securities purchase agreement for the issuance and sale of an aggregate of 4,166,663 shares of its common stock. In a document filed with the US Securities and Exchange Commission, the firm said that the purchasers are comprised of directors and officers of Accelerate Diagnostics or entities affiliated with such persons. The closing of the purchase and sale of the shares is expected to occur in three approximately equal tranches, the firm said. The first tranche already closed on Feb. 19, and the second tranche closed on April 9 when Accelerate issued to the purchasers an aggregate of 1,388,886 shares for proceeds of approximately $10.7 million.

Last week, Judge Cormac Carney of the US District Court for the Central District of California dismissed a class action suit against Ambry Genetics related to a January 2020 data breach.

"Plaintiffs fail to plausibly allege that their injuries were caused by defendants' actions," Carney wrote. "The problem is that the harm plaintiffs allege they suffered is not fairly traceable — at least not plausibly so — to the conduct they complain of. For example, plaintiffs allege that unauthorized parties obtained their passwords, but there is no allegation that any of plaintiffs' passwords were stolen in the data breach." Carney left open the possibility for the plaintiffs to improve their arguments and gave them 14 days to file a new complaint.

Ambry alerted customers to a breach in April 2020, revealing that it had exposed customers' names, medical information, information related to customers' use of Ambry’s services, and, in some instances, social security numbers. The plaintiffs — 24 individuals from 15 states — then sued, alleging negligence, invasion of privacy, breach of contract, and violation of state privacy and business laws, among other claims.

Infinity BiologiX said this week that it has won a contract for an undisclosed amount from the US Centers for Disease Control and Prevention to provide genomic sequencing and new variant identification for SARS-CoV-2 samples. The company will sequence viral genomes of random, de-identified US samples that test positive for the virus during diagnostic testing and will provide the CDC with viral sequence data for its surveillance efforts.

In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared on 360Dx.