CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
Shield launches test for antibiotic susceptibility in N. gonorrhoeae
April 2019—Shield Diagnostics launched Target-NG, a rapid molecular test for antibiotic susceptibility in Neisseria gonorrhoeae.
“Rapid molecular testing for ciprofloxacin resistance allows for smarter medicine,” Jeffrey D. Klausner, MD, MPH, a professor of infectious disease medicine at the University of California, Los Angeles, said in a Shield statement. “Right now we’re treating gonorrhea with a sledgehammer; we’re treating everything with the same exact regimen. And it’s not a surprise that the organism will become resistant to what we’re currently using.”
Ciprofloxacin can be used to treat 80 percent of infections and is 99.8 percent effective when susceptibility has been determined. Because it is administered as a single oral dose, rather than the current injectable treatment, clinicians can prescribe antibiotics for the patient to give to their partners.
“Shield has launched Target-NG to help clinicians adopt a precision medicine approach to gonorrhea treatment,” said Nidhi Gupta, PhD, lead scientist on the project.
“Target-NG can determine if a given gonorrhea infection is susceptible to ciprofloxacin with the same turnaround time as regular gonorrhea screening tests,” Fred Turner, the company’s CEO, said in a statement. “This is enabling prescription of a single-dose pill as an effective treatment for gonorrhea.” The test is available from urine, rectal, and pharyngeal samples.
FDA grants accelerated approval to Tecentriq in combination with Abraxane
The Food and Drug Administration has granted accelerated approval to Genentech’s Tecentriq (atezolizu- mab) plus chemotherapy (Abraxane) for the treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer whose tumors express PD-L1 as determined by an FDA-approved test.
This indication is approved under accelerated approval based on progression-free survival. Continued approval may be contingent upon verification and description of clinical benefit in a confirmatory trial or trials.
The FDA also approved Roche’s Ventana PD-L1 (SP142) Assay as the first companion diagnostic to aid in identifying triple-negative breast cancer patients who are eligible for the treatment.