NEW YORK – Enzo Biochem said this week that its fiscal first quarter revenues were up 10 percent year over year, driven by increased demand in multiple product areas. For the three months ended Oct. 31, the Farmingdale, New York-based molecular diagnostics company reported total revenues of $7.8 million compared to $7.1 million a year ago. Enzo's Q1 net loss was $6.6 million, or $.13 per share, compared to a net loss of $10.6 million, or $.22 per share, a year ago. The company finished the quarter with $69.2 million in cash and cash equivalents.
Thermo Fisher Scientific said this week that the Biomedical Advanced Research and Development Authority (BARDA) has selected the company's PPD clinical research business to implement the first BARDA-supported Phase II platform clinical trial to study therapeutic options for treating acute respiratory distress syndrome (ARDS). The goal of the study is to gather clinical and biomarker data on ARDS patients to inform future clinical studies and the development of targeted therapies. The three-year, randomized, double-blind, placebo-controlled, multicenter trial will evaluate the safety and efficacy of three therapeutics at up to 60 sites in the US, enrolling 600 hospitalized adult patients with ARDS. The drug candidates to be tested will be announced in early 2024.
Pangea Laboratory said this week that it has received breakthrough device designation from the US Food and Drug Administration for its noninvasive Bladder CARE assay, which is intended for urine-based diagnosis of bladder cancer and upper tract urothelial carcinoma in patients presenting with blood in their urine. The test measures the methylation levels of three urothelial cancer-specific DNA biomarkers in a single qPCR reaction, with reported sensitivity and specificity of about 94 and 93 percent for the detection of bladder cancer, and 96 percent and 88 percent for UTUC. Pangea said it is preparing multicenter clinical trials as the next step toward applying for premarket approval from the FDA.
10x Genomics said this week that it has launched the Xenium Catalyst Network, a group of "technically qualified research institutions" that can provide access to proof-of-concept data from the spatial platform. The network members are the McDonnell Genome Institute, South Korea's Macrogen, California-based BioChain Institute, and Houston-based K2bio.
CareDx said this week that it is offering its Transplant Pharmacy services to patient members of the National Foundation for Transplants in an effort to help them better manage post-transplant medication adherence. The company's Transplant Pharmacy team helps patients coordinate benefits to reduce out-of-pocket costs and helps ensure that patients receive regular personalized care.
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.