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2026 Contestants
Learn about the 2026 contestants and their disruptive technologies. Finalists will be announced in late May.
Semifinalists
Anvil Diagnostics, Inc. | MycoScan
Augurex Life Sciences Corp. | SPINEstat® Immunoassay
In Diagnostics | Quic Liver and Kidney Panel
Kompass Diagnostics | Multimodal Electrical Sensor
Prolight Diagnostics | Psyros Digital Immunoassy
Anvil Diagnostics, Inc.
Product/Technology
MycoScan
Organization description
Anvil Diagnostics spun out of Rice University in 2022 to dramatically expand the multiplexing of commercial dPCRs for direct-from-blood pathogen diagnostics in hospital settings. Anvil will first launch its MycoScan™ assay in 2026 - a reagents and software package - that enables pan-fungal differentiation from cell-free DNA in plasma. With dPCR well adopted in settings managing patients at disproportionate risk of fungal infections (cancer & transplant centers, academic hospitals), Anvil brings a solution that can be readily accessed as an RUO assay as it continues development towards FDA clearance. As a pre-seed startup, Anvil has raised $2M in funding, initiated on-site pilots with 3 different hospitals testing its beta assay, and rallied significant support from major dPCR platform providers. Invasive fungal infections have 50-80% mortality rates, yet standard-of-care diagnostics either rely on invasive sampling and culture with about 50% yield and long turnaround times, or <10% yield from blood. There are no FDA-cleared blood tests on the market that resolve pathogen species, forcing clinicians to use multiple send-out tests with incomplete coverage. Clinicians rely on positive diagnoses before prescribing antifungals due to their severe toxicity and dangerous interactions with many drugs.
MycoScan will enable reliable, noninvasive, and fast fungal testing with hardware that many hospitals have, combining the simplicity and accessibility of PCR with the breadth of DNA sequencing. Anvil has also demonstrated cross-application to bacterial testing and envisions a suite of simple liquid biopsies that help hospitals manage infections at all phases in critical care. Anvil's first product, MycoScan, is a minimally invasive pan-fungal blood test capable of identifying 41+ fungal species from plasma with a turnaround time of <4 hours. It addresses a critical unmet need in laboratory medicine: the diagnosis of invasive fungal infections (IFIs) in hospitalized immunocompromised patients, where current diagnostics detect fewer than 10% of early cases from blood alone. MycoScan will initially be released as a research use-only product, which can be rapidly validated by hospital mycology laboratories to best serve patients in need. Anvil has no subsidiaries and is currently pre-revenue.
Product/Technology summary
Anvil Diagnostics has developed MycoScan™, the world's first pan-fungal digital PCR blood test capable of identifying nearly any fungal pathogen (41 species tested so far) in a single 3.5-hour workflow from 2 mL of plasma. Our patent-pending technology uses semi-specific primers that generate unique multi-locus 'fingerprints' for each target pathogen. Combinations of amplicons can be detected from the highly fragmented pathogen DNA found in plasma with dPCR, and the raw data can be deconvolved (much like assembling sequencing reads) to resolve the quantities of pathogens in the sample. Ultimately, this lends pan-fungal discrimination on standard dPCR instruments already present in >60% of NCI cancer centers, and cancer patients represent a major risk group for fungal infections. In analytical validation, MycoScan™ achieved a limit of detection of ≤1 genome copy per assay (>10× below standard PCR benchmarks) for 7 key species including A. fumigatus, >93.3% analytical specificity when tested on healthy donor plasma and plasma with various bacterial pathogens (the primary differential diagnosis), and successful detection of all of the most clinically critical fungal genera for patients with invasive fungal infections. Three active on-site pilots are demonstrating real-world detection of Aspergillus, Mucorales, and Fusarium in patient samples, with one site’s initial samples demonstrating concordance with a market-leading NGS test at 6/6 positive and 2/2 negative calls. Anvil anticipates price parity with traditional PCR’s, a fraction of the cost and turnaround time of NGS, helping MycoScan™ become the frontline test that transforms how fungal infections are diagnosed in the most vulnerable patients.
Augurex Life Sciences Corp.
Product/Technology
SPINEstat® Immunoassay
Organization description
Augurex Life Sciences Corp. is a commercial-stage diagnostics company dedicated to translating disease-specific biology into clinically relevant laboratory tests for autoimmune and inflammatory conditions. Our core expertise centers on targeting 14-3-3eta, a joint-derived protein integral to inflammatory disease pathways, to address unmet needs in earlier diagnosis, prognosis, and disease monitoring. Augurex pioneered 14-3-3eta–based diagnostics in inflammatory arthritis. The 14-3-3eta blood test is approved as JOINTstat® in Canada and Great Britain and is used to support clinical decision-making in rheumatoid arthritis. In the U.S., 14-3-3eta testing is available via LDT pathways using analyte-specific reagents.
Our diagnostic portfolio also includes SPINEstat® (Anti-14-3-3eta Multiplex Autoantibody Immunoassay), a first-in-class laboratory diagnostic for axial spondyloarthritis (axSpA), approved in Canada and the UK, and recently recognized by the U.S. FDA with Breakthrough Device designation. SPINEstat® measures multiple autoantibodies to 14-3-3eta. When combined with clinical findings, signs and symptoms consistent with axSpA, it aids in diagnosis, addressing the serious and prolonged multi-year diagnostic delay that arises when inflammatory back pain is misclassified as mechanical. FDA Breakthrough designation underscores SPINEstat’s potential to improve early, accurate differentiation of inflammatory versus mechanical back pain. Designed for laboratory medicine, Augurex technologies integrate seamlessly into existing clinical laboratory workflows and are in use or advanced validation across major labs in North America, with international expansion underway. We collaborate with clinicians, academic centers, industry partners, and patient advocacy organizations to ensure real-world utility and clinical impact by advancing biology-driven diagnostics that help get the right patients to specialty care sooner.
Product/Technology summary
Chronic back pain is one of the most common and challenging diagnostic problems in medicine, affecting nearly one-third of U.S. adults. Primary care teams must distinguish inflammatory back pain from far more prevalent mechanical causes, yet laboratory medicine has had no approved disease-specific-diagnostic tools to support this decision. This gap leads to years of uncertainty, unnecessary imaging, inefficient referrals, and significant burden on patients and the healthcare system. Within this population, axSpA is the most common cause of inflammatory back pain, affecting an estimated 4.7 million Americans. Despite its prevalence, axSpA is associated with an average diagnostic delay of 9 years in North America, during which patients experience ongoing inflammation, irreversible structural damage, chronic pain, and loss of function. The absence of a validated laboratory test has been a central driver of this delay.SPINEstat® directly addresses this unmet need. It is a first-in-class, blood-based diagnostic that detects disease relevant autoantibody responses associated with axSpA. By complementing tools such as CRP, HLA-B27 and imaging, SPINEstat provides a biologically grounded signal that helps differentiate inflammatory from mechanical back pain, enabling earlier diagnostic confidence, improved triaging, and more efficient referral to rheumatology. SPINEstat has been recognized with FDA Breakthrough Device Designation and achieved regulatory approvals in Canada and Great Britain. By enabling laboratories to play a transformative new role in the evaluation of chronic back pain, SPINEstat has the potential to shorten diagnostic delays, improve outcomes for axSpA patients, and redefine clinical pathways for one of medicine’s most pervasive diagnostic challenges.
In Diagnostics, Inc.
Product/Technology
Quic Liver and Kidney Panel
Organization description
In Diagnostics, Inc. (InD) was founded to retrieve exponentially more information from a single drop of blood, by miniaturizing and combining blood testing capabilities onto a digital microchip. Since Dr. Florescu’s demonstration of a 1-bit, Yes/No test for Dengue Fever in 2010, the information extracted from a drop of blood using microchips has doubled every 3 years, what we call Moore’s Law of blood testing. To finance exponential technology scaling, the market must grow equally fast. Uncompromising microchip integration has eliminated the need for an instrument. The single-use disposables connect directly to a phone or PC through a USB dongle. This approach expands access to testing in previously unreachable markets, like the home, collapses sales cycles, and eliminates reverse-compatibility constraints on new designs, launched initially in the unregulated veterinary market. The quality of the results is nevertheless paramount. We’ve demonstrated ~10% CVs and R2 ≥ 0.95 on human samples for both clinical chemistries and high sensitivity immunoassays. Our 32-bit clinical chemistries provide 4 quantitative liver and kidney indications from a finger-stick, namely ALT, AST, BUN, and creatinine. To enter the market, InD has spoken with the FDA and established a viable 510(k) pathway for at-home testing. Comprehensive finger-stick testing will radically increase access to high quality care for chronic diseases in the most under-served communities, and a company intentionally organized to foster exponential blood testing scaling is the key to sustained innovation.
Product/Technology summary
The American Liver Foundation estimates 100 million Americans have liver disease, while the CDC estimates 36 million have kidney disease. The Quic Liver and Kidney Panel is a rapid blood test for home use that facilitates management of these chronic, progressive conditions. Plasma concentrations of ALT, AST, BUN, CRE are available from 50µL of whole blood obtained from a finger-stick. The single-use disposables connect to a personal phone or PC through a low-cost USB-dongle. This platform introduces the rapid chemistry segment to the IVD market: finger-stick sampling, no instrument, multiplexed and quantitative operation with connectivity to providers. The Quic Liver and Kidney Panel demonstrated R2 of 0.99, 0.99, 0.95 and 0.96 on N=54 clinical human serum samples and R2 of 0.96, 1.00, 0.97 and 0.96 on N=23 heparinized human whole blood samples from ZSFGH against the Abaxis Piccolo Xpress equivalent Abaxis Vetscan VS-2 for ALT, AST, BUN and CRE, respectively. Within each disposable, whole blood cells are filtered, and the plasma is permitted to flow by capillary action into reaction cuvettes loaded with measured, dried enzymes. A 4-color, 8-cuvette microchip-integrated spectrophotometer with LED illumination measures absorbance changes in the cuvettes from standard enzymatic reactions. The analytical concentrations are calculated and displayed numerically on the screen, with AI-assisted interpretation and tele-consult. As a result of exponential technology scaling, the 8-plex, 64-bit implementation that includes ALP, GGT and TBIL will be launched in the veterinary market this year, while the 16-plex, 128-bit implementation that integrates electrolytes and immuno-assays is slated for 2030.
Kompass Diagnostics
Product/Technology
Rapid multimodal electrical transduction platform, IDA
Organization description
Kompass Diagnostics aims to expand healthcare beyond walls to shape new workflows that reduce healthcare costs, alleviate capacity shortages, and improve access to care. Kompass Diagnostics was founded by veterans in diagnostic commercialization, experts in semiconductor research, and entrepreneurs from Stanford University, the University of Chicago, and UCLA, with a vision to build a novel transduction platform that pioneers the next generation of point-of-care diagnostics. Its technology is the first multimodal diagnostic platform capable of delivering clinical-grade biochemistry, immunoassay, and molecular diagnostics in a single palm-sized device. Its proprietary electrical transduction assay (ETA) platform exhibits analytical sensitivity comparable to state-of-the-art laboratory technologies, enabling a broad menu of tests across diverse point-of-care settings based on finger-prick whole blood analysis within 10 minutes. The company’s first test is a rapid, multi-hormone test that guides time-sensitive decisions in fertility treatments like in vitro fertilization and egg freezing, reducing turnaround from hours to ten minutes. By increasing clinic capacity to serve more patients and reducing the operational costs of clinics, Kompass allows clinics to scale with a rapidly increasing demand for fertility treatments.
Product/Technology summary
A major barrier to decentralized, near-patient diagnostics is the absence of a signal transduction modality that achieves both analytical precision and amenability to miniaturization required for point-of-care settings. Kompass Diagnostics has developed a palm-sized multimodal platform delivering clinical-grade chemistry, immunoassay, and molecular diagnostics. The technology has demonstrated high analytical sensitivity across representative diagnostic biomarkers. Kompass reached femtogram per milliliter level detection limits for HIV p24 and five minutes turnaround for molecular Hepatitis B Virus. At its core is an Electrical Transduction Assay (ETA) framework, a proprietary electrical signal transduction technology that decouples analytical fidelity from instrument- and matrix-dependent constraints, enabling the technology to work in simple lateral flow fluidics. Kompass’s beachhead product, IDA, is the first rapid multi-hormone test that enables finger-prick whole blood analysis at the point-of-care within ten minutes. As societies shift towards declining fertility rates, delayed family planning, and increased coverage, demand for fertility treatments is rapidly growing. By reducing turnaround from hours to ten minutes, IDA improves clinical efficiency, allowing providers to treat more patients, reducing costs, shortening wait times for patients, and improving access to care. Hormone assays, particularly estradiol, must be both highly sensitive and robust to cover a broad clinical range of 5-10,000 pg/ml, which makes it challenging for conventional diagnostic platforms to deliver lab-quality performance at the point-of-care. IDA hormone assays have demonstrated strong correlation against clinical laboratories and is nearing design freeze. Through its 513(g) submission, Kompass has confirmed that a 510(k) dual track submission is appropriate for IDA.
MADx
Product/Technology
Allergy Xplorer 3 (ALEX³)
Organization description
Founded in 2016, MADx has established itself as a leading developer and manufacturer of high-precision allergy multiplex tests. The company's focus is on the development of revolutionary immunodiagnostic solutions, serving laboratories, medical practices, hospitals, and allergy centers worldwide. At the forefront of allergy diagnostics, MADx bridges the gap between scientific innovation and clinical reality. Our commitment to quality and technical advancement ensures that our diagnostic solutions stay at the cutting edge, empowering clinicians to make precise, evidence-based decisions for every patient.
Product/Technology summary
Allergy diagnostics remains tethered to outdated, extract-based testing. MADx is disrupting this field with ALEX³, the world’s first big-data-driven multiplex IgE test. By transitioning from crude extracts to molecular allergens, ALEX³ provides a comprehensive "immunological fingerprint" of patients by assessing 300 analytical features from 145 different allergen sources in a single step. Our technology is disruptive because it solves three limitations of traditional diagnostics: (1). ALEX³ is the only platform featuring an integrated cross-reactive carbohydrate determinants (CCD) inhibitor to eliminate clinically irrelevant results that lead to misdiagnosis. (2)ALEX³ replaces multiple rounds of IgE single-plex testing with a high-density, ‘one-shot’ diagnostic, thereby reducing the ‘time to diagnosis’, improving both the patient experience and overall care. (3)ALEX³ leverages a unique big-data approach to curate its allergen composition based on global sensitization patterns, ensuring clinical relevance for both common and rare allergen sensitizations.
RAVEN, our interpretation guidance software, is an additional key differentiator. It is an educational tool that solves the "interpretation gap", by simplifying complex sensitization patterns into clear clinical insights, giving healthcare providers in allergy the confidence to interpret results and determine suitable treatment options. By shifting toward data-driven precision medicine, ALEX³ supersedes 20th-century methods with efficient, high-throughput systems that offer higher specificity without sacrificing sensitivity.
Prolight Diagnostics
Product/Technology
Psyros(TM) Digital Immunoassay Platform: A single molecule counting system designed for point-of-care applications.
Organization description
Psyros Diagnostics, based at Discovery Park in Kent, UK, is a wholly owned subsidiary of Prolight Diagnostics, based in Lund, Sweden, and listed on the Nordic Growth Market (PRLD). Psyros was formed in 2018 by 4 PhD scientists with a proven track-record in the IVD industry, with the goal of developing a next generation point-of-care IVD system based upon single molecule counting. The company was funded partly through UK government grants (totalling £2.9M / $3.95M), funds from the founders and a degree of consultancy work, until Psyros was acquired by Prolight Diagnostics in 2022.There are currently 22 employees in the UK, including scientists, engineers, manufacturing technicians, quality, regulatory, finance and admin roles. The founders have a strong track-record in IVD, having previously been founders or key staff in another UK start-up, Vivacta, that was acquired by Novartis in 2012 for $90M. The company’s vision is to develop an ultra-sensitive point-of-care IVD platform that combines best-in-class sensitivity with an extremely competitive cost of goods. Having identified single molecule counting as the best approach to tackle the next generation of point-of-care diagnostics, the founders set about developing their own IP in this area. Six patent applications have been filed, with 4 now granted (3 in Europe, 1 in Japan).
Product/Technology summary
Prolight Diagnostics are in the late stage development of the Psyros(TM) point-of-care immunoassay platform. The system combines a novel approach to single molecule counting, coupled with an extremely simple, low-cost disposable cartridge, designed for high volume manufacture. The assay functions in whole blood, without the need for cell separation. With strong patent protection and clear freedom-to-operate, we have demonstrated best-in-class analytical and pre-clinical data on our commercial prototypes. The unique core technology underpinning the platform uses reactive oxygen species to permanently bleach dark spots in a fluorescent sensor – each dark spot represents a single binding event. Our state of the art instrument images the sensor, counting each binding event and converts this into analyte concentration. Working with our trusted global partners for instrument design (G&H ITL), cartridge manufacture (Flex Medical Solutions) and clinical studies (MDx CRO), we are on the cusp of commercialisation. The cartridge manufacturing line is going through the last stages of validation and pilot instruments are expected over the next few months. We are gearing up for our pivotal clinical performance study to prepare our high-sensitivity troponin assay for regulatory approval. Beyond troponin, we see exciting opportunities and are actively engaged in new projects with third parties to satisfy unmet clinical needs at the point-of-care. We have a strong internal team backed by an impressive clinical advisory board. Prolight – Diagnostics you can count on!