The firm is developing an electrochemical sensor platform to detect sepsis and other conditions using a single drop of blood and a single-use cartridge.
The test expands the firm's Zika product pipeline, which also consists of a molecular assay authorized for emergency use.
The test can measure lower levels of troponin, enabling doctors to more accurately identify patients who actually have an acute myocardial infarction.
The vice president of clinical programs at ACP discusses what's happened in the five years since a report made recommendations on how to cut down on unnecessary testing.
The firm has plans to complete a US-based clinical trial and file for FDA approval early this year.
Commenters told the FDA that antigen-based rapid influenza diagnostic tests have performed poorly, and the reclassification will "mitigate" health risks.
Executives provided updates on their companies at the 35th Annual JP Morgan Healthcare Conference in San Francisco, CA, Day 3.
The firm is launching the test for bacterial vaginosis in Europe, the Middle East, and North Africa.
Executives provided updates on their companies at the 35th Annual JP Morgan Healthcare Conference in San Francisco, Day Two
Chembio will pay up to $1.5 million in cash and up to 291,066 shares of Chembio common stock, among other things, as part of the deal.
The firm said it has received CE marks for its blood and plasma screening system, as well as its clinical chemistry and immunoassay diagnostics systems.
The two firms will have the ability to develop instruments for commercialization within the IVD space.
The assay is to help clinicians assess the prognosis of primary colon cancer, in combination with the TNM classification and other clinical and biological features.
CLIA waivers are driving the promise of MDx uptake in physicians’ offices, but achieving adoption in larger settings will remain a strategic imperative.
The grant will go toward creating a diagnostic technology center to develop methods for detecting protein biomarkers at the point of care.
The company is eyeing a launch of its HIV test in additional geographies, as well as the launch of its hCG test in 2017.
The US Preventive Services Task Force said that the potential harms resulting from screening for HSV outweigh the potential benefits.
The three-year trial used immunoassays and PCR testing, and found 335 Babesia microti positive samples among 89,153 blood donations.
The firm is developing a sepsis and SIRS diagnostic that combines its own molecule counting technology with Thermo Fisher's procalcitonin assay.
According to Cedars Sinai Medical Center's Jennifer Van Eyk, mass spec-based proteomics' clinical potential is on the cusp of being realized.