NEW YORK – 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. The 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.
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.
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.
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.
Trinity Biotech said this week that it has closed its previously announced $45 million strategic investment from South Korea-based MiCo. The investment comprises 11.2 million American Depositary Shares at $2.25 per share and a seven-year, unsecured junior convertible note for $20 million, convertible at $3.24 per share. The funds will go toward the repayment of a portion of Trinity's $81.3 million term loan, which will reduce its annual interest cost by about $4 million each year. The company will also use the investment to explore lower-cost debt funding options in the short term.
The Davos Alzheimer’s Collaborative said this week that it is launching a global pilot program with seven sites to provide digital cognitive assessment tools and C2N’s blood-based PrecivityAD test to increase timely and accurate diagnosis of Alzheimer’s disease. The pilot sites will provide localized care and treatment for patients, along with developing models for larger healthcare systems to implement. C2N’s test uses mass spectrometry to measure blood amyloid beta (Aβ) 40, Aβ 42, and apolipoprotein E levels. It uses these along with a patient’s age to generate a score of 0 to 100, with a higher score indicating a higher likelihood of the amyloid brain plaques characteristic of Alzheimer's disease.
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.
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.
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.
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.