SIVAD Diagnostic Medical Group LLC (SIVAD) Combats Opioid Deaths with Launch of HarmGuard FX™, the Only Combination Fentanyl and Xylazine Test Strip Available in the U.S.

Pilot program in Delaware provides blueprint for national uptake of a highly accurate, easy-to-use harm reduction tool with potential to save lives

BEAR, Del. — June 28, 2023 — SIVAD Diagnostic Medical Group LLC (SIVAD), a minority-owned company dedicated to addressing the unique needs of underserved and unserved communities in the United States and globally, today announced the launch of HarmGuard FX in Delaware, the first state in the nation to distribute this groundbreaking approach to reducing overdose deaths. HarmGuard FX is a single, low-cost strip that provides an affordable, reliable way for people to test substances for fentanyl and xylazine (popularly known as tranq), two dangerous adulterants that are exacerbating the already critical opioid epidemic.

The U.S. Drug Enforcement Administration (DEA) recently reported that it had found the deadly combination of fentanyl and xylazine in nearly a quarter of drugs sampled from 48 out of 50 states.¹ According to the Centers for Disease Control and Prevention (CDC), between 2018 and 2021, deaths involving xylazine increased by 1,238%, leading the White House Office of National Drug Control Policy to designate fentanyl combined with xylazine as an emerging threat to the U.S.²

“As a company committed to leveraging technology to democratize health care and address the needs of underserved and marginalized communities, SIVAD developed our Harm Stopper™ Program to provide comprehensive resources that can reduce the harm of fentanyl and xylazine for substance users, the community advocates who support them, health professionals, and law enforcement personnel,” said Jermonica Boardley, CEO and President at SIVAD, who is leading the Harm Stopper Program. “We commend Lt. Governor Bethany Hall-Long for making Delaware the first state to pilot HarmGuard FX and are collaborating with Delaware health officials spearheaded by Susan Holloway to implement a pilot program that could serve as a blueprint for other states seeking to prevent overdose deaths. As other states receive and deploy funds from the National Opioids Settlement, we hope to work with them to implement HarmGuard FX and our Harm Stopper Portal as part of their harm-reduction strategies.” 

SIVAD’s Harm Stopper Program includes the HarmGuard FX test strip and the Harm Stopper Portal. The comprehensive, cloud-based, AI-driven portal provides education, resources, and information at the national level, and for participating states, uses advanced geolocation to provide the user with instant access to local resources and information related to harm reduction. Using the QR code on each HarmGuard FX package, people can quickly find local, free naloxone distribution locations, needle exchange programs, counseling, emergency services, and other resources – complete with hours of operation, distance from the user, and any special requirements such as training. It also provides a one-click call option on mobile devices. The portal includes information for commercial and public sites and resources, including all standalone pharmacies and pharmacies within larger stores.

“Delaware is committed to responding to the opioid crisis with the urgency it demands. We know harm reduction strategies work, and this new test provides another useful tool we can use to protect residents and save lives,” said Lt. Governor Bethany Hall-Long, Ph.D., R.N., Chair of the Delaware Behavioral Health Consortium. “This pilot program is the epitome of what Delaware does best – boots-on-the-ground outreach, homegrown innovation, and collaborative partnerships. I’m thrilled our state will be the first in the nation to distribute these groundbreaking test strips, and we are eager to get these tests out in the community.”

According to the CDC, Delaware has the third-highest overdose death rate per capita in the U.S. In 2022, at least 537 Delaware citizens died from drug overdoses, according to the state’s Division of Forensic Science – the most overdose deaths on record for the state.³ About 80% of these deaths involved fentanyl, a powerful synthetic opioid 50 to 100 times more potent than heroin.

Xylazine, a non-opioid tranquilizer primarily used as a sedative, analgesic, and muscle relaxant in large animals, has emerged as an adulterant in recreational drugs. Fentanyl and xylazine alone or combined can cause severe respiratory depression, leading to a lack of oxygen, brain damage, or even death. Additionally, the combination can cause a significant drop in blood pressure, leading to circulatory collapse and organ failure. While fentanyl overdose can be reversed with Narcan, there is no reversal agent for xylazine, making it even more crucial to detect its presence in substances to prevent fatal overdoses.

The HarmGuard FX test, meticulously validated by a U.S.-based, FDA-registered testing lab, is a lateral flow immunoassay designed for forensic use. This innovative tool swiftly detects both fentanyl and xylazine in various substances including powders, pills, or residue from baggies or cookers, functioning in a similar manner to the fentanyl-only test strips used across the U.S. for several years. To use the test, a small sample of the substance is mixed with water. The test strip is then dipped into the solution for 15 seconds. As the liquid interacts with the strip, it engages with highly selective antibodies against each substance in two distinct test regions and a control region. After waiting for five minutes, the results can be read, offering a quick way to identify the presence of these dangerous adulterants. If the test is working correctly, the control region will show a red safety line. If the sample is free of xylazine, the xylazine test region will show a red safety line, and if it is free of fentanyl, the fentanyl test region will show a red safety line. The absence of a safety line in the fentanyl or xylazine test area means that fentanyl or xylazine is present in the sample.

When using HarmGuard FX, “three is key,” — as the presence of three safety lines indicates that the test was performed correctly and did not contain fentanyl or xylazine. Fewer than three safety lines are an indication of danger. HarmGuard FX is designed to indicate safety; a test line indicates that the substance being tested is free from the dangerous adulterant.

If you or a loved one is struggling with addiction, call the U.S. Substance Abuse and Mental Health Services Administration National Helpline at 1-800-662-HELP (4357) to be connected to treatment facilities, support groups, and community-based organizations in your area. Delaware residents can call the Department of Health and Social Services (DHSS) 24/7 Crisis Hotline to be connected to the treatment and recovery options phone number. To search online for treatment and recovery services in Delaware or nearby states, visit HelpIsHereDE.com. An additional source is the Harm Stopper Portal accessible via the QR code on all HarmGuard FX pouches.

About SIVAD Diagnostic Medical Group LLC (SIVAD)

SIVAD Diagnostic Medical Group LLC (SIVAD), headquartered in Bear, Delaware, is a minority owned company dedicated to addressing the unique needs of underserved and unserved communities in the United States and globally. With a focus on providing essential personal protective equipment (PPE) and COVID-19 testing during the pandemic, SIVAD has expanded its mission to tackle various domestic and global public health challenges, such as substance abuse and infectious diseases. Lenzie Davis is Chairman of the Board of SIVAD Diagnostic Medical Group LLC, a subsidiary of SIVAD Group.

Media Contact:
Elizabeth Bement, FINN Partners
[email protected] 
703-915-5830

Sources:

1. “Public Safety Alert.” United States Drug Enforcement Administration. November 2022. https://www.dea.gov/alert/dea-reports-widespread-threat-fentanyl-mixed-xylazine
2. Gupta, Rahul et al. “Xylazine -- Medical and Public Health Imperatives.” N Engl J Med 2023; 388:2209-2212. 10.1056/NEJMp2303120.
3. Edelman, Hannah. “2022 overdose deaths follow troubling pattern as state, advocates struggle to catch up.” Delaware News Journal. 14 June 2023. https://www.delawareonline.com/story/news/health/2023/06/08/delaware-overdoses-rising-sussex-county-black-community-xylazine/70293302007/