Years after several high-profile failures, activity is up among researchers looking to multi-analyte protein assays for monitoring and detection of the disease.
The workflow — which involves two immunoassays instead of the standard immunoassay followed by a Western blot — was tested using the agency's Lyme Serum Repository.
Based on the level of 25 serum markers, the test is meant to assess risk of both spontaneous preterm delivery and deliveries indicated by an underlying condition.
The tests are based on Chembio's Dual Path Platform chromatographic immunoassay technology, which can detect antibodies within 15 minutes using fingerstick samples.
The investment bank cited disappointing first quarter financial results, a slow uptake to the business, and competitive pressures for the downgrade.
Inspired by the electronic breadboards used to prototype electronic devices, the system is meant to enable flexible and inexpensive design of clinical tests.
The findings run counter to historical data and may provide fodder to reconsider current guideline recommendations on surveillance of colorectal cancer patients.
Pro-Lab will shepherd Medicortex's kit through the regulatory processes in Canada and the UK, as well as clinically validate it. It will have exclusive rights to sell the kit in the two nations.
Sphingotec's proenkephalin and adrenomedullin biomarkers and Nexus Dx's Nexus IB 10 point-of-care testing platform will be merged under jointly owned holding company Polaris MediNet.
The partners will combine Chembio's DPP technology and biomarkers developed at Mass General for diagnostic tests for typhoid and febrile illness.
The firm is positioning the technology, called Morffi, for use in lateral flow immunoassays, particularly in infectious disease diagnostics, such as influenza tests.
The study found the test could distinguish between a viral and a bacterial infection with 94.3 percent specificity and 93.5 percent sensitivity.
Roche is developing an immunohistochemnistry assay for Pierre Fabre's oncology drug candidate, an antibody drug conjugate targeting insulin-like growth factor 1 receptor.
Opko has until July 5 to comment on the proposed non-coverage local coverage determination, the most recent development in the test's twisted Medicare narrative.
Ortho said it will initially launch Sentinel's wide-range C-reactive protein assay in North America, Europe, Africa, and the Middle East.
Product revenues were $613,000, down from $678,000 in Q1 2017, while service revenues were $36,000, down from $48,000 the year before.
The newly independent firm will continue to invest in diagnostics by bringing its menu of PCR tests for infectious diseases to the US and other markets, among other objectives.
Microdrop will license the rights to market SQI's celiac and wheat allergy, and arthritis tests direct to consumers.
The company has developed a suite of tests designed to measure immunoglobulin E and immunoglobulin G levels for allergy and dietary wellness testing.
The firm's product revenues were up 19 percent year over year, while license and royalty revenues, as well as R&D, milestone, and grant revenues increased sharply.