The agency granted clearance for the Ansh Labs PicoAMH ELISA test, which measures the amount of Anti-Müllerian hormone in the blood.
The researchers said the test could predict progression and prognosis among women with breast lesions and could be more reliable than tumor margin inspections.
The new factory will be the company’s first in vitro diagnostic reagent plant in the Asia Pacific region, producing clinical chemistry and immunoassay reagents.
Called CerMark, the test is aimed at women in resource-constrained settings and will measure proteins linked to HPV infection and cervical disease progression.
Chembio's Q3 revenues are expected to rise between 21 and almost 24 percent year over year. It is purchasing OpTricon, which develops handheld analyzers, for $5.5 million.
The company is developing point-of-care tests for monitoring kidney function (penKid) and endothelial dysfunction in patients at risk of heart failure.
The company's third quarter revenue increase was driven in part by strong growth in its molecular biology clinical applications.
Molecular diagnostics revenues rose 5 percent driven in part by growth in infectious disease testing, a core area of diagnostic market focus for the firm.
The investment bank expects Abbott's Diagnostic division to grow in the mid-single digits driven in part by global launches of its Alinity systems.
A diverse group of researchers and diagnostic industry participants has collaborated to produce two papers that describe and critique Lyme disease testing technologies.
The firm is developing tests combining biomarkers and other clinical measures to diagnose and monitor patients and identify those at risk of long-term effects.
Bio-Techne said that the firms will collaborate to develop "better and more accurate" point-of-care diagnostic tools for the Chinese market.
Becton Dickinson got clearance for a platform and test for the rapid identification and determination of antimicrobial susceptibility of gram-negative bacteria.
The National Institutes of Health Commercial Accelerator Program helps small healthcare and life science companies bring their products to market.
The POC assay is being developed under a DoD contract to detect pathogens that may pose a threat to national security and public health.
DiaSorin will sell its H. pylori stool antigen test for use on DiaSorin's Liaison platform. The firms will also end pending legal disputes.
As part of the legal settlement, Akers Bio will pay $930,000 to Pulse Health, and it has agreed to a permanent injunction against selling a disposable breath test.
The firm said that it will use the proceeds to roll out a fully automated point-of-care platform that enables use of a broad panel of acute blood biomarkers.
The firm said that its system is expected to deliver up to 50 AST tests per day and match the daily production of the highest-throughput systems in the market.
The firm is taking its in-home monitoring systems for COPD and cystic fibrosis, and its professional-use sepsis confirmation system through clinical trials.