CDC reports transmission of drug-resistant Candida auris with threat level – urgent

Candida auris is an emerging multi-drug resistant, highly transmissible yeast (a type of fungus) affecting especially severely ill patients with weakened immune system mostly in the long-term care health facilities (Ref, Candida auris | Candida auris | Fungal Diseases | CDC).

  1. aurisspreads from skin wounds and leads to invasive infections in bloodstream. The most common specimen sources of clinical cases of C. auris are blood (40%), urine (28%), wound (8%), and sputum (6%) (Ref, Overview of Candida auris and Emerging Resistant Candida (fda.gov)). According to CDC, azoles (e.g., fluconazole), polyenes (e.g., amphotericin B), and echinocandins are three major classes of antifungal medications for a treatment of C. auris infection. Multidrug-resistant C. auris is a concerning clinical and public health threat.
  2. auris was first identified in 2009 in Asia and began spreading in the United States in 2015. According to Center for Disease Control and Prevention, reported cases of C. auris increased 318% in 2018 when compared to the average number of cases reported in 2015-2017 (Ref, Drug-Resistant Canida Auris (cdc.gov)). Recently CDC reported outbreaks of a multidrug-resistant C. auris among patients in hospitals and long-term facilities in Texas and Washington, D. C. during January -April 2021. (Ref, Notes from the Field: Transmission of Pan-Resistant and Echinocandin-Resistant Candida auris in Health Care Facilities ― Texas and the District of Columbia, January–April 2021 | MMWR (cdc.gov)).

It has been reported (Ref, 155. Public Health Action-based System for Tracking and Responding to U.S. candida Drug Resistance: AR Lab Network, 2016–2019 | Open Forum Infectious Diseases | Oxford Academic (oup.com)) that approximately 85% of C. auris isolates in the U.S. are resistant to azoles, 33% to amphotericin B, and 1% to echinocandins. Based in this data, echinocandins are thus recommended as a first-line therapy for most invasive Candida infections (Ref, Clinical Practice Guideline for the Management of Candidiasis: 2016 Update by the Infectious Diseases Society of America – PubMed (nih.gov)).

Integrity laboratories, offers multiple PCR-based molecular diagnostic tests for a detection of variety of infection disease’s pathogens of genitourinary and respiratory tracts, as well wound, including biofilm using AmpliteCtTM Pathogen Load IndicatorTM (PLITM) (Ref, Precision Diagnostics – Advanced Antimicrobial Solutions (integritylaboratories.com). C. auris is one of fifteen pathogens detected in patient specimens using our Biofilm panel. Integrity Laboratories’ laboratory developed test (LDT) identifies not only pathogens, e.g. C. auris, but also provide Pathogen Load IndicatorTM (PLITM). PLITM utilizes the ability of the qPCR technique to rapidly quantify the pathogens genetic material and calculate the percentages of detected pathogens in tested patient sample. In addition, Integrity Laboratories’ developed LDT for a detection of fifteen drug-resistant genes in detected pathogens to assist clinicians in identifying the appropriate antimicrobial treatment for patients. Providers and patients enjoy the confidence of next day test results paired with antibiotic resistance markers eliminating the need for defensive administration of broad-spectrum antibiotics.

-Maria Cekanova, RNDr, PhD

Integrity Laboratories began testing for SARS-CoV-2 (COVID-19) under Emergency Use Authorization (EUA) on March 23.

Please direct all inquiries to covid19@integritylaboratories.com for immediate review.

FDA Authorization Letter   |   FDA EUA Summary

CARES Act Statement