The RealStar Zika Virus RT-PCR Kit 1.0 has been listed by the World Health Organization as eligible for procurement agencies and member states.
The firm sees the new panel as an important step forward in its strategy to further penetrate the molecular diagnostics market with its qPCR products.
Facing CMS sanctions, lab industry insiders ponder the firm's options in seeking to launch a Zika virus assay with emergency use authorization on its upcoming miniLab platform.
The test was designed by diagnostics maker GenArraytion and uses the Luminex xMAP technology.
Laboratories have access to a growing number of antibody and molecular tests, thanks in part to FDA Emergency Use Authorizations, but they need more serology resources.
The firm's multi-analyte quality controls for nucleic acid tests are designed to help large and small labs mitigate quality challenges.
The PCR-based assays run on the company's Aries system, which itself received FDA clearance in October 2015.
The point-of-care test detects and distinguishes influenza A and B as well as respiratory syncytial virus in about 20 minutes.
The company will soon submit its ePlex instrument and respiratory pathogen panel for US Food and Drug Administration clearance.
The firm saw decreases in its core diagnostics business that were offset in part by revenues from newly-acquired Magellan Diagnostics.
The agency has doubled the window after suspected exposure during which it recommends RT-qPCR testing for some pregnant women.
Despite the array of tests available, some lab directors are still seeking broader functionalities and capabilities from the systems they purchase.
Molecular biology sales rose 38 percent, driven by €52 million in Q2 sales of the firm's FilmArray molecular diagnostic products.
The rapid molecular test showed 98 percent sensitivity and 97 percent specificity on more than 1,000 throat swabs prospectively collected at four US sites.
The Australian firm is planning to seek US Food and Drug Administration approval for one of its PCR-based multiplex panels in the future.
The test is now the first FDA-cleared test for use with the SurePath collection medium and vial for processing cervical cancer screening samples.
The additions comprise 297 new species, including Mycobacterium tuberculosis, 45 species of non-tuberculous mycobacteria, and 48 medically important molds.
The firm is hiring new scientific and managerial staff as it targets distinct markets in Africa for its nucleic acid amplification-based resistance test.
The recent approvals underscore the usefulness of procalcitonin as a sepsis biomarker, even as newer molecular approaches to diagnosing the condition hit the market.
The assay is designed to measure changes in blood levels of the peptide precursor procalcitonin to differentiate bacterial infections from viral ones.