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In Brief This Week: Sema4, Mirvie, Caris Life Sciences, Prenetics, 23andMe, More

NEW YORK – Sema4 said this week that it has closed its purchase of GeneDx from Opko Health for $623 million in cash, stock, and milestone payments. Under the terms of the deal, Sema4 paid Opko $150 million in cash along with 80 million shares of its stock, valued at $323 million, for a total upfront consideration of about $473 million. Opko may receive revenue-based milestone payments of up to an additional $150 million during the next two years. Stamford, Connecticut-based Sema4 also closed a previously announced private placement of $200 million worth of Class A shares at a price of $4 per share to a group of institutional investors including Pfizer. 


Pregnancy health company Mirvie this week received US Food and Drug Administration breakthrough device designation for its preeclampsia test to gauge a woman’s risk of developing preeclampsia before symptoms occur. According to the firm, the cell-free RNA-based blood test is the first within its category to receive FDA breakthrough device designation, which intends to expedite the development of medical technologies that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. 


Caris Life Sciences said this week that Loma Linda University Cancer Center has joined its Precision Oncology Alliance, a network of cancer centers across the globe that collaborate to advance precision oncology and biomarker-driven research. The Caris POA currently includes 63 cancer centers and academic institutions. Members gain early access to Caris' database and artificial intelligence platform for cancer profiling and molecular testing in oncology, as well as to CODEai, the company's database with cancer treatment information and clinical outcomes data for over 275,000 patients. 


Hong Kong-based diagnostic company Prenetics this week reported a 60 percent year-over-year increase in revenues in Q1. For the three months ended March 31, revenues totaled $92.0 million, up from $57.5 million in Q1 2021, driven by demand for the firm’s diagnostics and genetic testing services. The company said it has delivered more than 22 million laboratory and at-home tests to date. Loss from operations was $600,000, down from a profit of $11.1 million in the first quarter of 2021, due to an increase of noncash share-based payment associated with an increase in the equity value of the firm. Prenetics ended the quarter with $34.2 million in cash and cash equivalents and $59.2 million in trade receivables. The firm also said it expects to be listed on the Nasdaq on May 18 in connection with its merger with special purpose acquisition company Artisan Acquisition. 


23andMe said this week that customers can now schedule telehealth consultations on genetic test reports with care providers from Lemonaid Health, which the company acquired last year for $400 million. In this first phase of integration of Lemonaid, 23andMe will focus on genetic health risk reports for hereditary breast and ovarian cancers as well as for familial hypercholesterolemia. Subscribers to the 23andMe+ premium service will also be able to discuss pharmacogenetic reports with Lemonaid clinicians. Initial consultations will cost $65, while follow-up virtual patient visits will run $110, the company said. 


The UK's One Future Health research program said this week that it has added four new industry partners, which will provide additional investment of £40 million ($39.4 million). The new partners — Boehringer Ingelheim, Exact Sciences, Novo Nordisk, and Randox Laboratories — join 10 other life sciences companies that were announced as funding partners earlier this year. In addition to their investments, the companies will contribute their expertise in discovering and developing new methods for prevention, early detection, and treatment of diseases and health conditions. Our Future Health aims to collect genotyping and other information from 5 million participants in the UK. It has garnered £79 million in initial government funding from UK Research and Innovation. Later this year, the program plans to start inviting members of the public to participate. 


Meridian Bioscience said this week that it has acquired substantially all of the assets of Euprotein, a company offering custom development and production of bioresearch reagents with a focus on human and other mammalian proteins and recombinant monoclonal antibodies. Meridian said the acquisition will help it “accelerate its pipeline of new immunological reagents while expanding recombinant capabilities.” The deal closed on April 30. 


The US Food and Drug Administration announced this week organizational changes within the Center for Devices and Radiological Health. In the Office of Product Evaluation and Quality, the Office of In Vitro Diagnostics and Radiological Health will become two new offices, called the Office of Health Technology 7, Office of In Vitro Diagnostics, or OHT7, and the Office of Health Technology 8, Office of Radiological Health, or OHT8. FDA said the new structure will provide focused executive leadership and better meet the needs of stakeholder communities with divergent technologies and regulatory requirements. 

In addition, the Office of Clinical Evidence and Analysis will transition from two divisions to three, with the newly created Division of Clinical Science and Outreach joining the Division of Clinical Policy and Quality and the Division of Biostatistics. The Office of Regulatory Programs has also created a fourth division, called the Division of Regulatory Systems, Tools, and Data Management. 


Florida Cancer Specialists and Research Institute this week joined a global clinical trial evaluating OncoHost's diagnostic platform Prophet as a method to predict whether cancer patients will respond to immunotherapy. The trial, called PROPHETIC, is evaluating the platform in patients with stage IV non-small cell lung cancer, small cell lung cancer, and malignant melanoma. Ernesto Bustinza-Linares, a medical oncologist at Florida Cancer Specialists and Research Institute, is serving as a principal investigator for the study, which has 35 trial sites globally. 


Nîmes, France-based biotech firm Phylogene is collaborating with the French Alternative Energies and Atomic Energy Commission (CEA) to develop new microbiota analysis techniques. The parties will be using mass spectrometry-based metaproteomics to functionally characterize microbiota, with the goal of industrializing this analytical approach, which could ultimately benefit various sectors including the diagnostics industry. 


Global professional services firm ZS has acquired Danish bioinformatics and systems biology company Intomics for an undisclosed amount. Founded in Copenhagen in 2008, Intomics facilitates pharmaceutical drug discovery and development through the analysis of biomedical data. It has a highly curated protein-protein interaction network that is condition-agnostic and supports tailored biomedical analysis spanning multiple diseases. ZS said that the 42 members of Intomics will join its staff of about 12,000 employees worldwide and will help expand ZS’s existing data and technology offerings and analytics, bioinformatics, and applied mathematics capabilities. 


Binx Health said this week that it is partnering with student health insurer Wellfleet on an initiative to broaden access to HPV testing. Colleges and universities will be able to offer Binx’s technology solutions and at-home sample collection for diagnostic testing. 


Fauna Bio and Monash University’s Victorian Heart Institute have begun generating data on a set of compounds for treating pulmonary hypertension and are preparing to test additional therapy candidates for heart and lung diseases. The collaboration began in 2020 and makes use of Fauna’s Convergence drug discovery platform to validate genetic targets and compounds for disorders such as pulmonary fibrosis and pulmonary arterial hypertension. 


Veracyte said this week that an updated clinical practice guideline from the American Thoracic Society and other professional organizations, as well as a related review and commentary, discusses the role of the Envisia Genomic Classifier in the diagnosis of idiopathic pulmonary fibrosis (IPF). The company said more than 40 percent of the guideline authors voted to recommend genomic classifier testing in clinical practice. The classifier detects a genomic pattern of usual interstitial pneumonia, which helps physicians differentiate IPF from other interstitial lung diseases without surgery. The test, developed using whole-transcriptome sequencing and machine learning, is covered by Medicare. 


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.