The antibody, called leronlimab, is a CCR5 antagonist under development by CytoDyn for a variety of indications including HIV and breast cancer.
The firm said its assay is a real-time qPCR test for the direct detection of methicillin-resistant Staphylococcus aureus DNA in nasal swabs.
The firm's CEO said it is continuing to develop its distributor network to make its tests available in centralized and decentralized settings globally.
The anticipated shortage for clinics comes at a time when more clinicians are already switching to lab-based IGRA testing, diagnostic industry executives said.
iCubate said that it now has a comprehensive solution within European markets for the detection of bloodstream bacteria and important resistance markers.
The Frederick, Maryland-based firm has received regulatory clearance for a multiplexed array-based assay after more than 15 years in development.
The closure has no impact on the firm's other Los Gatos location, the original home of GeneWeave Biosciences, which Roche acquired in 2015 for up to $425 million.
The firm said that its multiplex point-of-care test uses 10 microliters of blood from a fingertip and provides quantitative results in about 15 minutes.
The VioOne HIV supplemental assay is for confirming and differentiating individual antibodies directed to various gene products of HIV-1 and HIV-2.
The tests run on the firm's sample-to-result automated molecular diagnostics instruments designed for use by high-volume labs.
Stakeholders discussed last year's decision by Palmetto to deny coverage for large respiratory panels and discussed the way forward for test developers and labs.
SpeeDx said it will work with GlaxoSmithKline on tests to support its antibiotic clinical trials, as well as its new product development efforts.
The firm is developing a portable, rapid MDx platform for infectious disease testing in clinics, and anticipates launching a first product in 2020.
McKesson will be the exclusive distributor of the QiaStat-Dx system in US hospitals with fewer than 200 beds and non-exclusive distributor for future expansion into retail pharmacy clinics.
The firm said it anticipates using the financing to support working capital requirements, platform development, and pilot manufacturing.
The complaint alleges that NeuMoDx is willfully infringing on six BD-held patents, and demands injunctive relief, damages, and a jury trial.
The high-throughput, scalable BD Cor system for infectious disease diagnostics is now available in Europe with the firm's BD Onclarity HPV assay.
The funding will support development of a test for the Zika virus using Ontera's silicon nanopore-based molecular diagnostics platform.
Some at-home infectious disease tests and sample collection kits exist in a murky regulatory realm, and their sale to patients is troubling laboratorians and clinicians.
The firm is starting a trial that it anticipates will lead to an application for marketing clearance with the US Food and Drug Administration by next year.