NEW YORK — The Association for Diagnostics & Laboratory Medicine (ADLM), along with the National Independent Laboratory Association, the American Association of Bioanalysts, American Society for Clinical Pathology, American Society for Microbiology, and the Infectious Disease Society of America, has filed an amicus brief this week in the American Clinical Laboratory Association’s (ACLA) suit against the US Food and Drug Administration (FDA) and its final rule on laboratory-developed tests. The brief supports ACLA’s position that the FDA rule exceeds the agency’s statutory authority and asks the court to strike it down.
Foresight Diagnostics filed a motion this week to dismiss the trade secret lawsuit brought against the company by Roche. In the motion, Foresight said that Roche failed to show any plausible trade secrets related to the case and failed to provide plausible factual allegations that the alleged trade secrets have independent economic value. It also said that the trade secret claims against Foresight should be dismissed because Roche has failed to allege any acts of misappropriation by Foresight.
T2 Biosystems and PRxcision this week announced they will comarket T2 Bio's rapid, direct-from-blood diagnostics and PRxcision's platform. The deal aims to deliver a "comprehensive approach" to managing bloodstream infections and sepsis by providing hospitals the ability to rapidly identify pathogens directly from blood in hours, compared to days with other methods, along with real-time insights and information. As a result, clinicians can receive information to guide treatment, the companies said. A T2 Bio spokesman declined to disclose the terms of the deal.
Babson Diagnostics this week said that it has received investments from Becton Dickinson. Babson added that Siemens Healthineers and Emerald Development Managers also provided new financing. Collectively, the investments will support Babson's commercial launch, it said. Babson and BD have collaborated since 2016 on developing a blood collection device that collects samples from a patient's fingertips, while Siemens is an existing strategic investor in Austin, Texas-based Babson and Emerald Development Managers was a lead investor in the company's Series B financing round. A Babson spokesperson declined to disclose the amount of the BD investment but said it was "substantial" and will enable "a significantly faster rollout of the company’s BetterWay testing. " In December, BD said it received US Food and Drug Administration clearances for a novel blood collection device and test system developed in collaboration with Babson.
Laboratory Corporation of America said this week that it has declared a cash dividend of $.72 per share of common stock. The dividend will be payable on Dec. 13 to stockholders of record as of the close of business on Nov. 26.
Prenetics this week reported second quarter revenues of $5.9 million, down from $6.5 million in Q2 2023. Net loss for the quarter was $11.5 million, or $.88 per share, compared to a net loss of $20.4 million, or $2.06 per share, in the year-ago quarter. As of June 30, the Hong Kong-based company held $41.2 million in cash and cash equivalents. This month, Prenetics plans to launch a health and wellness brand named IM8 in the US. It continues to expect more than $33 million in revenues for full-year 2024. The company noted that Insighta, its 2023 joint venture with Chinese University of Hong Kong scientist Dennis Lo that focuses on early cancer detection, had a cash balance of $80.5 million as of June 30. That company commenced a 1,500-person clinical trial for early liver cancer detection in September.
Naveris this week said Blue Shield of California began providing coverage for the NavDx test for tumor tissue modified viral HPV DNA as of July 2, 2024. Naveris markets the test for detection of HPV-driven cancers before treatment, during treatment, and after treatment.
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.