Antelope's founder said that being spun off by MyCartis gives his company the focus it needs to launch tests for use in homes and doctors' clinics.
Roche Diagnostics got the nod for its Elecsys Anti-HAV II test for the detection of total antibodies — IgG and IgM — to the hepatitis A virus.
The firm anticipates that point-of-care adoption may attract licensing deals from companies interested in adding the biomarkers to their large laboratory analyzers.
Clinical applications grew 11 percent driven by 34 percent growth in the molecular biology segment, including a 31 percent spike in FilmArray product sales.
The firm said it anticipates using the loan proceeds to fund its pursuit of corporate priorities, including broadening its product portfolio and geographic reach.
The new test would rapidly screen patient samples to determine whether biotin levels are present that could throw off the accuracy of other diagnostic tests.
The startup holds an exclusive license from Johns Hopkins University and intends to launch its test in time for World Malaria Day in April 2020.
The cancer immunotherapy regimen and companion diagnostic test will be available in Europe for patients with triple-negative breast cancer who express PD-L1.
ViroGates has also validated the instrument for use with its suPARnostic Quick Triage product, which will be included in the reader's test menu.
The two companies will work together to bring the point-of-care pretreatment diagnostic based on the XDX-01 biomarker to market in 2020.
By measuring and analyzing hospital testing operations, the firm anticipates helping its customers implement better antimicrobial stewardship programs.
The merger is aimed at expanding Salveo’s diagnostics capabilities and improving communication with providers and patients.
The firm offered more than 2.7 million shares of its common stock, including 356,435 shares to its underwriters pursuant to an option to purchase additional shares.
The company said it is pushing to begin simultaneous clinical trials for multiple small panel-based tests for its sample-to-answer Savanna platform.
The firm expects to use proceeds from the offering to expand its life sciences commercial operations, and improve and update its Simoa technology and instruments, among other initiatives.
The firm experienced a 30 percent jump in sales of immunoassays, attributed in part to a $6.2 million increase in influenza revenues year-over-year.
The company expects the rollout of more reliable, user-friendly platforms will increase instrument usage among a substantial segment of its customer base.
The firm received a notice from Nasdaq on August 2 saying its stock had not met the $1-per-share closing bid price requirement for 30 consecutive business days.
At the Henry Ford Health System in Southeast Michigan, bringing on the Roche Cobas Liat for flu testing led to a season of headaches before it started paying off.
Expedeon will supply Sona Nanotech with colloidal gold technology for use in the development of multiplex lateral flow assays.