The new women's health and STI tests for the BD Max platform are part of a small, focused panel approach which the firm believes will resonate with physicians and labs.
The firm plans to submit the Mycoplasma genitalium test to the FDA in 2017 and has entered an agreement with the CDC for test evaluation.
The test detects chlamydia, gonorrhea, and trichomonas from a single patient sample.
The antibiotic-resistant Mycoplasma genitalium test would be the first on the market for a pathogen with increasing evidence for adverse outcomes.
Under the agreement, Goffin will distribute SpeeDx's PlexPCR and ResistancePlus multiplex real-time PCR product lines in Benelux.
Evaluations of the test, which takes about 30 minutes to perform, demonstrated performance equivalent to a gold standard lab-based test.
The Australian firm provided an update on its in vitro diagnostics business, noting that it has also rebranded its core technologies and continues to license them.
The DxN Veris was recently launched as a CE-marked product with a menu of viral load tests, and will launch in a few years in the US with STD and HAI assays.
This is the first update to the guidelines since 2010, and the agency specifically calls out two of the three FDA-cleared Trichomonas NAATs.
The new assay expands the sexually transmitted infection menu for the cobas 4800 to three tests.
In Science this week: genetically modified flu virus could be key to new live vaccines, and more.
Biomedical research projects are generating a ton of data that still needs to be analyzed, NPR reports.
Theranos is retiring some of its board members, including Henry Kissinger and George Shultz, Business Insider reports.
The heads of 29 scientific societies and some 2,300 researchers call on President-elect Donald Trump to rely on and support science in two separate letters.