Product News

New Test Released to Help Clinicians Rapidly Determine Course of Therapy for Suspected Wound Infections

CogenDx, the genetics brand of Millennium Health LLC, San Diego, CA, has launched its newest test offering, DxWound. The test uses DNA-based technology to provide accurate, sensitive detection of an array of microbes, including aerobic and anaerobic bacteria, fungi, and antibiotic resistance genes. Results from the tests equip clinicians to rapidly and accurately identify potential pathogens causing infections and select antibiotics with greater likelihood for efficacy.

DxWound utilizes a simple swab to collect microbial DNA directly from the infection site and leverages a special transport buffer that preserves the wound microbiome during specimen transit, according to company officials. Test results are typically delivered the next business day from specimen receipt at the laboratory.

“Wound care is a critical part of a patient’s recovery, especially in the early stages of healing, where the process may be complex and fragile,” said Jennifer Strickland, chief executive officer, Millennium Health. “DxWound is the next iteration in our suite of genomic solutions that can improve the way clinicians prescribe antibiotic treatments for patients with suspected wound infections. Our goal is to fulfill a crucial need in healthcare and offer tools that help healthcare providers make rapid, targeted, effective therapy decisions for their patients.”

The DxWound test menu includes detection of microbes most frequently associated with skin and soft tissue infections (SSTI) and genes associated with resistance to a range of commonly used antibiotics and antibiotic classes. Also assessed are antibiotic-resistant pathogens listed as public health threats in the United States by the Centers for Disease Control and Prevention, such as methicillin-resistant Staphylococcus aureus.

Multiple agencies have issued a call to action in recent years urging development of newer diagnostic tests such as DxWound to help address the global crisis of antibiotic resistance and overuse, according to numerous reports. Molecular diagnostic solutions like DxWound provide information that is potentially more accurate and available much sooner than current methods, allowing clinicians to quickly select an antibiotic therapy that is targeted and more likely to clear the infection. This can translate to improved health outcomes for patients and reduced costs of care, particularly when treated within 48 hours of suspected infection.

As part of a planned portfolio of clinical research, CogenDx currently has a study underway to evaluate the economic impacts of inappropriate antibiotic therapy in inpatients being treated for SSTIs. Additional prospective studies are planned to help further evaluate improved outcomes with use of DxWound in high-risk populations. For more information, visit https://cogendx.com

MediWound Successfully Completes 2nd Cohort of EscharEx^® Phase 2 Study

MediWound Ltd., a fully-integrated, international biopharmaceutical company that focuses on treatment of severe burns and wound care, has reported positive top-line results from the second cohort of its Phase 2 clinical trial evaluating EscharEx^® for debridement of dead or damaged tissue in diabetic foot ulcers (DFU) and venous leg ulcers (VLU). The second cohort was a prospective, randomized, controlled, assessor-blinded trial to evaluate EscharEx safety over extended periods of application (24-72 hours) in up to eight applications to provide supportive data for a future filing for biologics license application. The second cohort included 38 patients living with DFUs or VLUs that were randomized to either EscharEx or the hydrogel vehicle at a ratio of 2:1, respectively. The top-line results include data following the completion of the debridement period by all patients. The primary objective of the second cohort of the study was to assess safety, company officials said.

The overall patient demographics and wound baseline characteristics were comparable across both arms. No related systemic adverse events were reported and adverse events related to local application were mild to moderate, reversible and resolved during the trial. Vital signs, pain scores, infection rates, laboratory parameters and blood loss were comparable between the two arms of the trial. Overall, no material safety concerns were identified.

“Effective debridement is a critical first step to facilitate wound management and is complementary to existing wound healing products, which require a clean wound bed,” said Lior Rosenberg, MD, chief medical technology officer at MediWound. “In the treatment of chronic wounds, it is important to adjust the treatment strategy to the patients' needs and wound conditions, and therefore establishing safety over extended period of application is important.”

Future plans are to initiate an EscharEx Phase 3 pivotal program in the United States in the first half of 2018.