The CDC received clearance for a number of influenza panels and kits. Agilent's assay for postnatal CNV detection, and Abbott's hematocrit test were also cleared.
The deal increases Metabolon's access to the European market and builds on its goal of bringing the value of metabolomics globally, according its CEO John Ryals.
The study is the first to demonstrate the design features and operational characteristics of Cepheid's Xpert MTB/RIF Ultra assay.
The present prototype is being expanded to use five liver cancer markers instead of one, and the researchers are developing it to detect other diseases.
The clinic, a partnership of the Florida Department of Health in Broward County and the AIDS Healthcare Foundation hopes to improve STD treatment and control.
Along with a change in guidelines, a number of payors have stopped paying for blood-based H. pylori testing, possibly heralding an uptick in sales for Exalenz's test.
The University of Illinois team developed the technology with an eye at low-resource settings, including developing nations and rural communities.
Its technology called CELx uses a patient's tumor cells to identify abnormal cellular activity driving their cancer and the most appropriate therapy.
By pressing on a piece of paper, a user could power up the test and potentially apply it in a remote location, the researchers said.
Researchers were able to identify a specific protein signature for Zika, opening up the possibility that the signature could could be used to screen for exposure to Zika.
Illumicare will provide ARUP clinicians with its Smart Ribbon tool that provides information on the cumulative risk and financial impact of tests and medications during the course of care.
The Human Diagnosis Project recently brought in partners in an effort to expand specialty care to underserved populations across the US and measure outcomes.
A proof-of-concept assay that uses an inkjet-printed nanoscale film achieved performance comparable to that of a laboratory ELISA while testing for leptin.
The offering consists of two tranches of $600 million each, and the firm plans to use the net proceeds for general corporate purposes, including the repayment of outstanding senior notes due on Aug. 23.
The company said it will use the funds to expand its menu of STI tests and launch its io rapid diagnostic platform into UK sexual health clinics.
The scientists argued that studies indicate the creatine kinase-myocardial band testing has no "incremental value to patient care" and outlined steps to put the test to rest.
Roche's HbA1c test, along with an immunoassay system from Shenzhen New Industries Biomedical, and a celiac test from Immco also received 510(k) clearance last month.
Astrego Diagnostics has been founded to commercialize the technology for the rapid detection of bacterial antibiotic resistance in UTIs.
For the three months ended June 30, the point-of-care infectious disease diagnostics firm posted $4.1 million in total revenues, up from $3.3 million in Q2 2016.
The firm's revenues related to the transfer of IP dropped 58 percent year over year, while service revenues declined 3 percent, and product revenues rose 27 percent.