FDA clears new rapid molecular test for antibiotic resistance genes
Diagnostics company OpGen announced today that it has received 510(k) clearance from the US Food and Drug Administration (FDA) to market a new rapid molecular diagnostic tool that could aid in treating antibiotic-resistant or non-susceptible infections.
The Acuitas AMR Gene Panel detects 28 genetic antibiotic resistance markers in bacterial isolates from 26 different pathogens, according to a company press release, and can rapidly and simultaneously test for resistance to select drugs in nine antibiotic classes. OpGen, of Rockville, Maryland, says it’s the broadest AMR panel cleared by the FDA.
“The benefits of this AMR panel for predicting antibiotic resistance include the provision of genomic profile data much sooner in about 2.5 hours versus conventional phenotypic information which can take 1-4 days, supports the goal of antimicrobial stewardship, institution of infection control and prevention measures, and alerts the provider to resistant genes representing nine classes of antibiotics,” James Snyder, PhD, director of microbiology and molecular diagnostics at the University of Louisville Hospital, said in the release.
OpGen says it plans to launch the device before the end of the year.
Oct 4 OpGen press release
WHO: Risk of spread high in Nigeria’s yellow fever outbreak
A yellow fever outbreak in Nigeria, under way since November 2020, has led to 1,321 suspected cases across all 36 of its states, as well as the Federal Capital Territory that includes Abuja, the country’s capital, the World Health Organization (WHO) said in a recent update.
The yellow fever outbreak is part of ongoing activity since 2017. In the latest outbreak, of 45 blood samples sent to the Pasteur Institute in Dakar, 31 were positive based on plaque reduction neutralization testing. Of those, 12 were vaccinated and 19 were unvaccinated and were from 7 different states. Two deaths were reported among the unvaccinated group.
Nigeria has gaps in immunity against yellow fever, with a 2020 estimate suggesting that national immunization coverage was 54%, well below the 80% threshold needed to protect against outbreaks. The WHO said other factors include poor performance of reactive mass immunization activities and suboptimal surveillance.
The risk of spread is high due to those factors and challenges responding to other outbreaks such as COVID-19, Lassa fever, and cholera. “Additionally, the recent relaxation of COVID-19 measures could increase population mobility and the potential risk for spreading yellow fever to urban areas,” the WHO said.
Nigeria is a priority country for vaccination, and preventive campaigns are being implemented in six phases with a goal of completing the steps by 2024. The WHO urged countries to take steps to keep travelers safe and aware of yellow fever symptoms and the need to quickly seek care if sick. The US Centers for Disease Control and Prevention (CDC) has instituted an alert level 2 (practice enhanced precautions) for people traveling to Nigeria.
Oct 1 WHO outbreak update
CDC travel notice for Nigeria
Dynavax, DoD advance next-generation plague vaccine
Dynavax Technologies, a pharmaceutical company based in Emeryville, California, today announced that it has executed an agreement with the US Department of Defense (DoD) worth $22 million over 30 months to develop a recombinant adjuvanted vaccine against plague.
The agreement covers a phase 2 clinical trial, slated to begin in 2022, that combines Dynavax’s CpG 1018 adjuvant with the DoD’s rF1V vaccine, according to a company statement.
Ryan Spencer, Dynavax’s chief executive officer, said the CpG 1018 adjuvant is used in a two-dose hepatitis B vaccine approved by the FDA. Multiple late-stage COVID-19 vaccine candidates also use the adjuvant.
Col. Ryan Eckmeier, with the DoD, said the military hopes the vaccine will protect service members with fewer doses administered over a shorter period.
As part of the agreement, the company would also submit an investigational new drug application to the FDA and generate more clinical trial results to add to its existing data. Plague is caused by Yersinia pestis found in fleas and rodents. The bacterium can cause the often-deadly pneumonic form of plague, and aerosolized Y pestis is considered a bioterror threat.
Oct 4 Dynavax press release