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In Brief This Week: 10x Genomics, Congenica, Epigenomics, Myriad Genetics, Biocartis, More

NEW YORK – The European Unified Patent Court this week denied 10x Genomics a second preliminary injunction against NanoString Technologies for alleged infringement of patents covering spatial biology technology. "While an additional injunction would have strengthened the outlook on 10x Genomics' case, the injunction itself would have been redundant," Barclays analyst Luke Sergott wrote in a note to investors. In September the UPC granted a preliminary injunction for CosMx Spatial Molecular Imager products based on a different patent infringement case.

Congenica said last week that it has won a two-year extension of its contract with the Hong Kong Genome Project (HKGP), a large-scale sequencing initiative in Hong Kong that is funded by the Hong Kong Special Administrative Region (HKSAR) government and implemented by the Hong Kong Genome Institute (HKGI). Financial terms of the renewed contract were not disclosed. Under the initial one-year contract, Congenica provided tertiary analysis of whole-genome sequencing analysis services for the project.

Epigenomics this week said it has closed its previously announced agreement for the sale of its major assets to New Day Diagnostics. Almost all of Epigenomics' assets have been transferred to New Day in return for a cash payment of $500,000 and an interest in New Day. Epigenomics is also entitled to a payment of $1 million as of Dec. 1, 2023, and $300,000 as of June 30, 2024. Additionally, the company is eligible for potential cash payments of up to $8 million depending on certain milestones related to the Epi proColon test and the Epi proColon Next Gen test. Epigenomics is also eligible for license payments and earn-out payments, primarily in the form of royalties on sales until 2043, dependent on the commercialization of Epi proColon Next Gen. The Berlin-based firm issued a new estimate for a 2023 loss between €4.5 million ($4.8 million) and €5.5 million, compared to an earlier estimate of a loss between €7 million and €9 million. The new range reflects the contract Epigenomics has with New Day. Estimated cash consumption for 2023 remains unchanged at between €7 million and €9 million, the company said.

Myriad Genetics this week established a new long-term agreement with UnitedHealthcare. The agreement includes pricing for MyRisk, MyChoice CDx, BRACAnalysis CDx, Foresight, Prequel, GeneSight, and Prolaris, among others. The new agreement runs from Jan. 1, 2024, through Dec. 31, 2027. Additional terms of the deal were not disclosed. 

Biocartis of Mechelen, Belgium, said this week that it has expanded its collaboration with Apis Assay Technologies, a UK-based molecular diagnostics company, to include the commercialization of the Apis ESR1 Mutations Kit, a qualitative qPCR test, through Biocartis' global commercial network. Biocartis will distribute the kit, with an initial focus on Europe. Earlier this year, the two companies had announced a partnership to develop and commercialize the Apis Breast Cancer Subtyping assay on Biocartis' Idylla platform.

Utica, New York-based Masonic Medical Research Institute this week announced a project led by Nathan Tucker, an assistant professor of biomedical research and translational medicine at the research center, has received a $3.9 million grant from the National Institute of Health's National Heart, Lung, and Blood Institute to study genetic factors linked with cardiac arrythmia risk. During the five-year study, investigators will aim to identify genes that contribute to cardiac arrythmia, which they say could underpin development of new therapeutics.

Theradiag this week announced its financial results for the third quarter of 2023, reporting sales of €3.2 million ($3.4 million), up 20 percent from €2.6 million in the year-ago quarter. The increase was driven largely by the company’s in vitro diagnostics business, which grew 44 percent year over year to €1.6 million, Theradiag said in a statement. Theranostics revenues increased 4 percent to €1.6 million. The company ended the quarter with cash and cash equivalents of €5.5 million.

The company also noted that its board of directors has approved the absorption of Theradiag into Biosynex. The decision will be submitted for the approval of Theradiag and Biosynex shareholders at the annual meeting in December. Last year, Biosynex filed a takeover bid to purchase the remaining shares of Theradiag it did not already own.

MDxHealth this week reported preliminary third quarter 2023 revenues of approximately $19.3 million, representing an increase of 73 percent over the same period last year, including $8.1 million from the Genomic Prostate Score assay, $6.6 million from Confirm MDx, $2.7 million from Resolve MDx, and $1.9 million from Select MDx. Excluding the Genomic Prostate Score assay, the firm estimated that its Q3 revenue increased by 45 percent year over year. Its billable test volume for the quarter ended Sept. 30 was 4,932 for Confirm MDx, 2,938 for Select MDx, and 6,742 for Resolve MDx. The company ended the quarter with $32.7 million in cash.

Korea-based cancer molecular diagnostics company Gencurix announced this week that it has obtained regulatory approval in Australia for its Droplex POLE Mutation Test targeting endometrial cancer mutations. The test uses Droplet Digital PCR to detect abnormalities in the DNA polymerase epsilon (POLE) gene, potentially reducing unnecessary treatments and improving prognosis and treatment outcomes for patients with endometrial cancer. Gencurix has applied for the inclusion of other Droplex companion diagnostic tests in the Australian Register of Therapeutic Goods and plans to leverage the recent approval to expand into other countries which are members of the Medical Device Single Audit Program (MDSAP).

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.