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 said it is on track for solid future growth based on the expectation for new product approvals and continued strength in the CareFusion product portfolio.
The assay runs on the BD Max System, which combines automated real-time PCR extraction, amplification, and detection on a single platform.
The committee questioned stakeholders about the impact of FDA oversight of LDTs, and whether there was any consensus about how to move forward on a divisive topic.
The test detects chlamydia, gonorrhea, and trichomonas from a single patient sample.
The pre-market approval application is based on data collected during a two-year prospective study of more than 33,000 women.
Diagnostic systems strength was driven by strong growth in molecular and installations in Western Europe .
As part of a development and global distribution agreement, the companies will develop and launch a kit directed towards mitigating a growing HAI-related concern.
The PCR-based panel tests for the pathogens that cause three types of gynecological infection: bacterial vaginosis, candidiasis, and trichomoniasis.
The firm beat analyst estimates for earnings per share during the quarter, and raised its adjusted EPS guidance for the year.
In Science this week: metagenomic-based technique for determining protein structure, and more.
An academic laments the rise of narcissism in the sciences, the Guardian reports.
Outgoing FDA commissioner Robert Califf writes in an editorial that the agency can help boost innovation.
The Trump transition team has asked NIH Director Francis Collins to remain at his post, though it's unclear for how long that will be.