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New findings at ADLM 2025 could remedy this CHICAGO, July 28, 2025 /PRNewswire/ -- According to research presented today at ADLM 2025 (formerly the AACC Annual Scientific Meeting & Clinical Lab Expo), standard drug screening misses low concentrations of targeted substances in around 5% of urine samples taken from patients under age 18, suggesting that children with drugs in their systems are sometimes released from healthcare settings into unsafe home environments. The study highlights an adjustment that clinical labs can make to improve the accuracy of results and to help ensure that substance-exposed children and their families get appropriate support. Researchers have long known that standard urine drug screening (UDS) — which is typically done using a technique known as immunoassay — can sometimes trigger false positives, or erroneous results that indicate the presence of a drug when there isn't one. It's the reason a second confirmatory test with mass spectrometry is typically used to verify results for patients who test positive on immunoassay. However, the opposite issue, where UDS indicates an absence of drugs in patients who have actually taken them (false negatives), has not been well studied. This mistake is more likely to occur in samples taken from infants and young children whose kidneys are still developing or who have incidental exposure to a low level of drugs, resulting in a low drug concentration in their urine that may not reach the cutoff used in standard UDS. One approach for minimizing this possibility is to use mass spectrometry on all pediatric patients, skipping the initial immunoassay. "To our knowledge, St. Louis Children's is the only hospital in the U.S. to adopt this 'direct-to-mass-spectrometry' approach," said Dr. Yanchun Lin, one of the study's authors and a clinical chemistry fellow at Washington University in Saint Louis, Missouri. "So we really want to urge laboratorians to reconsider the approach they adopt for pediatric UDS testing." The researchers used two strategies to compare immunoassay results with mass spectrometry for detecting substances in common drug tests, including amphetamine/methamphetamine, cocaine/benzoylecgonine (the main metabolite of cocaine), THC, opiates, fentanyl, benzodiazepines, and methadone. In the first approach, they studied 125 urine samples over a 5-month period from pediatric patients with weakly positive results on mass spectrometry to check how many of them were missed by immunoassay (forward approach). For the second strategy, they assessed 115 urine samples that tested negative on immunoassay to assess if mass spectrometry could detect any drugs (reverse approach). Among the 125 samples that tested positive on mass spectrometry, 112 (approximately 90%) contained compounds not detected by immunoassay, most commonly methamphetamine and benzoylecgonine. Thirty-eight (33%) of the 115 samples found negative on routine UDS tested positive for at least one substance when re-examined by mass spectrometry. Moreover, mass spectrometry identified substances in six samples (5%) that were targeted but missed by immunoassay. In addition, the researchers identified 32 pediatric urine samples that contained prescription medications not picked up by immunoassay, including lorazepam, ketamine, bupropion, methylphenidate, clonidine, quetiapine, venlafaxine, and naloxone. They also found five samples containing fentanyl, which wasn't on the UDS menu at some study centers from which samples were taken. Taken together, the results indicate that UDS may miss low drug concentrations in approximately 1 in 20 pediatric urine samples. This finding held true using both the forward and reverse schemes, spanning multiple clinical environments and analytic platforms. Using a direct-to-mass spectrometry approach would significantly lessen the risk of false-negative drug screens and largely eliminate false-positive findings as well, the authors conclude. That said, making this change isn't without challenges for labs. "It's actually pretty labor intense," Lin said, "and it's much harder to maintain the assay" using the direct-to-mass spectrometry approach. "You need highly trained personnel and dedicated full-time employees," she added. But labs that can make the shift will benefit from more accurate results that could translate to better care. "If it's possible, it should definitely be adopted, especially for pediatric patients," Lin said. Session information ADLM 2025 registration is free for members of the media. Reporters can register online here: Abstract A-349: False-negative immunoassay drug screens uncovered with a direct to mass spectrometry approach in a pediatric population will be presented during: Student poster competition Monday, July 28 9:30 a.m. – 4 p.m. Room S405 Scientific poster session Tuesday, July 29 9:30 a.m. – 5 p.m. (presenting authors in attendance from 1:30 – 2:30 p.m.) Poster Hall on the Expo show floor Both sessions will take place at McCormick Place, Chicago. About ADLM 2025 ADLM 2025 (formerly the AACC Annual Scientific Meeting & Clinical Lab Expo) offers 5 days packed with opportunities to learn about exciting science from July 27-31 in Chicago. Plenary sessions will explore urgent problems related to clinical artificial intelligence (AI) integration, fake medical news, and the pervasiveness of plastics, as well as tapping into the promise of genomics and microbiome medicine for personalized healthcare. At the ADLM 2025 Clinical Lab Expo, more than 800 exhibitors will fill the show floor of the McCormick Place Convention Center in Chicago, with displays of the latest diagnostic technology, including but not limited to AI, point-of-care, and automation. About the Association for Diagnostics & Laboratory Medicine (ADLM) Dedicated to achieving better health for all through laboratory medicine, ADLM (formerly AACC) unites more than 70,000 clinical laboratory professionals, physicians, research scientists, and business leaders from 110 countries around the world. Our community is at the forefront of laboratory medicine's diverse subdisciplines, including clinical chemistry, molecular diagnostics, mass spectrometry, clinical microbiology, and data science, and is comprised of individuals holding the spectrum of lab-related professional degrees, certifications, and credentials. Since 1948, ADLM has championed the advancement of laboratory medicine by fostering scientific collaboration, knowledge sharing, and the development of innovative solutions that enhance health outcomes. For more information, visit . Christine DeLong ADLM Director, Editorial and Media Relations (p) 202.835.8722 [email protected] Bill Malone ADLM Senior Director, Strategic Communications (p) 202.835.8756 [email protected] SOURCE Association for Diagnostics & Laboratory Medicine (ADLM) WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

GAITHERSBURG, Md., July 28, 2025 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE: EBS) today announces its recognition of the U.S. House of Representatives for adding over-the-counter (OTC) naloxone to every AED location in its buildings, providing direct access to first responders and anyone coming across an individual who may be experiencing an opioid overdose. This effort has been led by Representative Buddy Carter (R-GA), with his team and congressional constituents, who have kept this public health issue a priority. Expanding access to potentially life-saving treatments is critical to saving more Americans and their families from an opioid overdose death. Emergent remains focused on saving lives through efforts to increase access, awareness and the availability of NARCAN® Nasal Spray 4 mg and KLOXXADO® Nasal Spray 8 mg. Emergent strives to engage with key stakeholders committed to reducing overdose deaths, as one death is one too many. “The efforts of Representative Carter (R-GA) to make naloxone readily available in the U.S. House of Representatives are commendable, and we are pleased to recognize his work to help save a life during an opioid overdose emergency,” said Joe Papa, president and chief executive officer at Emergent. “We believe the over-the-counter availability of naloxone, including our product, NARCAN® Nasal Spray, has directly contributed to the reduction in overdose deaths reported by the U.S. Centers for Disease Control and Prevention. Measures like this reinforce the importance of having life-saving naloxone nearby as an opioid overdose can happen to anyone, anywhere and at any time.” In 2023, Emergent launched NARCAN® Nasal Spray as the first OTC opioid overdose reversal treatment. With more than 85 million doses distributed in the U.S. and Canada since 2016, it is an important tool in helping save lives from opioid overdose, including those caused by fentanyl. Emergent is the leading U.S. supplier of nasal naloxone, and offers an expanded range of products to support public interest groups, workplaces/businesses, as well as patients, consumers and healthcare providers. NARCAN® (naloxone HCl) Nasal Spray 4 mg (two-dose carton)NARCAN® Nasal Spray Wall Unit Kit: includes wall unit cabinet with alarm, poster and wayfinder signKLOXXADO® (naloxone HCl) Nasal Spray 8 mg (two-dose carton)Convenience Kits: includes medical grade components including: One hard case with internal pockets, one medical grade CPR mask, one pair of nitrile examination gloves Visit NARCANDirect® or one of Emergent’s product sites, KLOXXADO.com and NARCAN.com to learn how to be prepared in an opioid overdose emergency with life-saving intranasal naloxone. About NARCAN® Nasal SprayNARCAN® Naloxone HCl Nasal Spray 4 mg is the first FDA-approved, over-the-counter (OTC) 4 mg naloxone product for the emergency treatment of opioid overdose. NARCAN® Nasal Spray is not a substitute for emergency medical care. Repeat dosing may be necessary. Use as directed. Important Safety Information for KLOXXADO® (naloxone HCl) Nasal Spray 8 mg What is KLOXXADO® Nasal Spray? KLOXXADO® Nasal Spray is a prescription medicine used for the treatment of an opioid emergency such as an overdose or a possible opioid overdose in adults and children with signs of breathing problems and severe sleepiness or not being able to respond.KLOXXADO® Nasal Spray is to be given right away and does not take the place of emergency medical care.Get emergency medical help right away after giving the first dose of KLOXXADO® Nasal Spray, even if the person wakes up. What is the most important information I should know about KLOXXADO® Nasal Spray?Get emergency medical help right away after giving the first dose of KLOXXADO® Nasal Spray. The signs and symptoms of an opioid emergency can return after KLOXXADO® Nasal Spray is given. If this happens, give another dose after 2 to 3 minutes using a new KLOXXADO® Nasal Spray and watch the person closely until emergency help is received. The medicine in KLOXXADO® Nasal Spray is safe to use in people who are not taking opioids. KLOXXADO® Nasal Spray is not intended for self-administration. What should I tell my healthcare provider (pharmacist or prescriber) before using KLOXXADO® Nasal Spray?Before using KLOXXADO® Nasal Spray, tell your healthcare provider about all of your medical conditions, including if you: have heart problemsare pregnant or plan to become pregnant. Use of KLOXXADO® Nasal Spray may cause withdrawal symptoms in your unborn baby. Your unborn baby should be examined by a healthcare provider right away after you use KLOXXADO® Nasal Spray.are breastfeeding or plan to breastfeed. It is not known if KLOXXADO® Nasal Spray passes into your breast milk. What are the possible serious side effects of KLOXXADO® Nasal Spray?KLOXXADO® Nasal Spray may cause sudden opioid withdrawal symptoms including body aches, diarrhea, increased heart rate, fever, runny nose, sneezing, goose bumps, sweating, yawning, nausea or vomiting, nervousness, restlessness or irritability, shivering or trembling, stomach cramping, weakness, and increased blood pressure. In infants under 4 weeks old who have been receiving opioids regularly, sudden opioid withdrawal may be life-threatening if not treated the right way. Signs and symptoms include seizures, crying more than usual, and increased reflexes. Who should not use KLOXXADO® Nasal Spray?Do not use KLOXXADO® Nasal Spray if you are allergic to naloxone hydrochloride orany of the ingredients in KLOXXADO® Nasal Spray. What are the most common side effects of KLOXXADO® nasal spray?The most common side effects of KLOXXADO® Nasal Spray in adults include stomach-area (abdomen) pain, weakness, dizziness, headache, nose (nasal) discomfort, and a feeling like you are going to faint. These are not all of the possible side effects of KLOXXADO® Nasal Spray. Please see full Prescribing Information, including Patient Information, which includes a more complete discussion of the risks associated with KLOXXADO® Nasal Spray. Always contact your healthcare provider (pharmacist or prescriber) if you have questions or experience any side effects. You are encouraged to report negative side effects to the FDA at: 1-800-FDA-1088 or www.fda.gov/medwatch. You can also contact Hikma Specialty USA Inc. at: us.hikma@primevigilance.com or call 1-877-845-0689 or 1-800-962-8364. Trademarks and logos are the property of their respective owners. About Emergent BioSolutionsAt Emergent, our mission is to protect and save lives. For over 25 years, we’ve been at work preparing those entrusted with protecting public health. We deliver protective and life-saving solutions for health threats like smallpox, mpox, botulism, Ebola, anthrax and opioid overdose emergencies. To learn more about how we help prepare communities around the world for today’s health challenges and tomorrow’s threats, visit our website and follow us on LinkedIn, X, Instagram, Apple Podcasts and Spotify. Investor Contact:Richard S. LindahlExecutive Vice President, CFOlindahlr@ebsi.com Media Contact:Assal HellmerVice President, Communicationsmediarelations@ebsi.com