Consider the children. This was the theme of a live-streamed event last night hosted by ADLM in Chicago, along with the American Medical Association and the Children’s Hospital Association. The three associations made the case yesterday that the FDA’s new rule regarding laboratory-developed tests would cause harm to healthcare, particularly in the realm of newborn screening and childhood disease.
They discussed how the FDA’s new rule will impede healthcare professionals’ ability to provide quality patient care. Attendees of this session will also hear from a caregiver and patient advocate on the importance of laboratory-developed tests in diagnosing medical conditions. The session closed with the speakers taking questions directly from the audience.
It is our prediction at Eye on IVD that this session at ADLM will be as effective in changing the FDA LDT rule as the association’s 2016 conference was in revealing the problems with Theranos.
A laboratory-developed test is a new or significantly modified test that is developed, validated, and used by highly trained laboratory medicine professionals within a single clinical laboratory in response to a specific patient care need. Most laboratory-developed tests are created because no Food and Drug Administration (FDA)-approved test is available. The FDA has now released a final rule bringing laboratory-developed tests under FDA oversight as well. The Association for Diagnostics & Laboratory Medicine (ADLM) has long maintained that any update to the regulation of LDTs should occur through CLIA.
The ADLM has a stronger voice in such matters because it has members in both the lab and the diagnostics community.
EXAMPLES OF LAB-DEVELOPED TESTS: A reminder that examples of lab-developed tests include rapidly scaling COVID-19 testing during the pandemic, offering reliable drug tests to prevent false positives, ensuring early detection of lead poisoning despite recalls of FDA-approved analyzers, and identifying a comprehensive range of BRCA mutations for better cancer risk assessment and treatment.
IVD Companies are not unaffected by the new LDT Rule. The industry earns billions of dollars in revenue from instruments and reagents and supplies sold to laboratories producing tests. There is no telling the revenue damage if LDT regulation causes labs to desist in producing their own tests.
EV BLOOD-BASED CANCER SCREEN WINS AWARD: Across many areas, but particularly in oncology, you are seeing systems that examine molecular activity instead of just finding a static marker. Mercy Bioanalytics won the Disruptive Technology Award Competition at ADLM for its blood-based cancer screening technology. Their Mercy Halo Ovarian Cancer Screening Test, a liquid biopsy platform, detects stage I cancer by analyzing blood-based extracellular vesicles (EVs) carrying unique cancer signatures. EVs are membrane-bound particles crucial for intercellular communication. This approach allows for low-cost, high-sensitivity, and high-specificity screening tests. The ovarian cancer test received breakthrough device designation from the FDA and the company plans to seek premarket approval by mid-2026.
POST PARTUM DEPRESSION TEST: A runner-up was the Enlighten Test, an AI-driven epigenetic test taken during pregnancy to predict postpartum depression (PPD) risk. Researchers identified a gene indicating a higher likelihood of hormonal impact on mental health. The test uses a machine learning algorithm to analyze gene expression based on extensive genetic profiles of pregnant individuals with and without PPD.
AUTONOMOUS BLOOD DRAWING: Increased testing is going to require increased blood draws. But that doesn’t line up well with recent worker shortages. Enter Vitestro. Vitestro was another runner-up for its autonomous blood-drawing device, combining AI-based, ultrasound-guided imaging with robotic needle insertion for accurate and secure blood collection. The device ensures a 95% first-stick success rate and 98% patient acceptance.
CALL FOR A DNA PASSPORT: In a plenary session, Ron H.N. van Schaik, PhD, promoted the idea of a “DNA passport,” a comprehensive pharmacogenetic (PGx) report for patients to share with healthcare providers. This concept aims to enhance personalized medicine by enabling clinicians to make informed drug choices, reducing trial-and-error approaches. PGx testing, like CYP2D6 genotyping, can predict drug efficacy and prevent adverse reactions. Over 300 drugs now require PGx testing, driven by clinical trials showing improved outcomes with DNA-guided dosing.
CLINICAL MASS SPEC: BENEFITS, AND CHALLENGES: Clinical mass spectrometry is essential for detecting metabolic disorders and monitoring drug effectiveness and toxicology, despite its challenges. In an ADLM session, Dennis Dietzen, PhD, and Stephen Roper, PhD, highlighted real-time mass spectrometry for therapeutic drug monitoring and rapid determination of 2-hydroxyglutaric acid in gliomas. While mass spectrometry offers molecular specificity and the ability to detect and quantify multiple substances from small samples, Roper noted its implementation difficulties in clinical settings requiring prompt results. Issues include sequential throughput, long chromatography times, complex calibration curves, manual data review, instrument upkeep, failures, and limited access to trained operators. Despite these challenges, Roper shared successes in using real-time mass spectrometry for drug screening in children. Dietzen discussed strategies for developing reliable mass spectrometry assays, emphasizing the need for fast and simple sample preparation, redundancy in hardware and personnel, and robust backup plans. He concluded with a call for laboratory professionals and industry partners to evolve to meet the growing clinical need for rapid mass spectrometry results.
LAB-IN-A-BOX: In the U.S., approximately 50% of adults skip routine blood testing due to its complexity and prolonged turnaround times. San Diego-based Truvian Health aims to address this with an automated benchtop platform for chemistry, immunoassays and hematology. The firm recently announced $74 million in new funding, which they say is enough to secure FDA clearance. Truvian’s device can be placed in physician offices, clinics, pharmacies, and long-term care facilities where samples can be run by non-laboratorians. Researchers from the University of California San Diego School of Medicine will be providing the latest evidence from a recent evaluation of the system. Samples from patients with a wide range of chronic illnesses were evaluated on the Truvian platform. The results produced by untrained operators using the Truvian platform were concordant with testing performed in the central laboratories by qualified medical staff. Truvian’s platform demonstrated run reliability of 98% and its user interface was described by 100% of operators as “easy to follow.”
ROBOT SOFTWARE FOR LABS: Robotic Process Automation or RPA software was the topic of a session“ Automating Digital Workflows in the Clinical Laboratory Using Robotic Process Automation,” by Simone Arvisais-Anhalt, MD, and Daniel Holmes, MD. The ADLM session illustrated how robotic process automation (RPA) software can perform repetitive computer tasks in clinical labs. Holmes detailed how RPA improves patient safety and health outcomes by allowing laboratory professionals to focus on more complex work. For example, automating the login of 2,500 research specimens into the laboratory information system reduced human work by 90% and eliminated transcription errors.
EXHIBITS: The ADLM 2024 exhibit floor opened Tuesday, showcasing various IVD vendors’ priorities.
- Roche treated booth visitors to a look at its future cobas® Mass Spec solution. The test design concept (not yet approved, no timeline on development) will add MS to core lab systems, and offer multi-analyte cartridge packs. They also demonstrated their cobas liat system, and cobas pure integrated solutions, among other diagnostic tools.
- BioMérieux presented their VITEK Reveal system for rapid blood culture testing. The VITEK system is modular and scalable. It can test a positive blood culture directly and provide results in 3 hours. Time is crucial for sepsis detection. They also demonstrated their new sore throat panel.
- Abbott focused on its 3-dimensional Lab Technology, GPL Automation, for lab design that maximizes a lab’s vertical space. Interlocking track components, open design, and use of spirals and elevation are features of the system.
- Siemens touted their Atellica Solution, which has the lowest water consumption among integrated platforms on the market, to help make your lab more sustainable by reducing overall water usage and environmental impact.
- Biosynth introduced Staboly, a synthetic alternative to bovine serum albumin for diagnostic platforms.
TOP VENDOR SPONSORS OF ADLM: ADLM Named its top corporate supporters including the following companies. (EYE ON IVD Finds these a useful study of who’s who in the industry): Abbott
- Aesku Group GmbH
- Anbio Biotechnology
- Beckman Coulter, Inc.
- bioMerieux
- Bio-Rad Laboratories
- Co-Diagnostics, Inc. (Co-Dx)
- Diagnostics Biochem Canada Inc.
- Diagnostica Stago, Inc.
- DiaSorin Inc.
- Diazyme Laboratories, Inc.
- Dirui Industrial Co., LTD
- Fapon Biotech Inc.
- Greiner Bio-One North America, Inc.
- Grifols
- Hamilton Company
- Healgen Scientific LLC
- Hologic
- HORIBA Medical
- IDS Co, LTD
- Inpeco S.A.
- LGC Clinical Diagnostics
- Nittobo
- Nova Biomedical Corporation
- Orchard Software Corporation
- QuidelOrtho
- Radiometer
- Randox Laboratories
- Revvity/EUROIMMUN AG
- Roche Diagnostics Corporation
- SARSTEDT
- Serbia
- Seegene, Inc.
- Siemens Healthineers
- SNIBE Co. Ltd. (Shenzhen New Industries Biomedical Engineering Co. Ltd.)
- Sysmex
- Tecan Trading AG
- Thermo Fisher Scientific
- Tosoh Bioscience
- Wallonia Export-Investment Agency
- Werfen
- WHPM/Hemosure
- Wondfo USA Co., Ltd.
- Zhejiang Gongdong Medical Technology
