Tender for newborn screening for rare lysosomal disorders

Tender for newborn screening for rare lysosomal disorders

Public buyers are turning to tandem mass spectrometry kits to extend newborn checks for rare lysosomal diseases, reshaping how such conditions are picked up.


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Instytut Matki i Dziecka has launched a Newborn Screening Kits Procurement to acquire tandem mass spectrometry kits for rare lysosomal storage disorders in newborns. The contract covers tests for Pompe, Fabry and Gaucher diseases and mucopolysaccharidosis type I, signalling an effort to broaden early detection of lysosomal storage disorders. Similar tenders in Germany and other health systems show public laboratories equipping themselves with more sophisticated diagnostic tools at the very start of life.

Screening newborns for lysosomal storage disorders

The notice describes the acquisition of newborn screening kits for lysosomal storage disorders, explicitly naming Pompe, Fabry and Gaucher diseases and mucopolysaccharidosis type I as the target conditions. The kits are to be used with tandem mass spectrometry, tying the screening programme to a specific analytical method and giving suppliers a clear sense of the technological environment into which their products must fit.

The summary does not mention expected test volumes, duration or whether the procurement is divided into lots, and it does not specify sample types or cut-off values. Such details are usually contained in the full tender documentation rather than the short notice. Even so, the description confirms that several lysosomal conditions are intended to be included within a newborn screening workflow based on tandem mass spectrometry.

For suppliers, the clarity on disease scope and analytical technique is significant. It narrows the field to providers that already manufacture or distribute kits for these specific lysosomal storage disorders and that can support their use on tandem mass spectrometry platforms in a laboratory setting.

Tandem mass spectrometry at the centre of neonatal testing

The requirement to use tandem mass spectrometry links this newborn screening tender with a cluster of recent procurements that place mass spectrometric techniques at the heart of routine diagnostics. On 12th November 2025, Universitätsklinikum Magdeburg A.ö.R. published a Mass Spectrometer for Newborn Screening contract notice, stating that the newborn screening programme in Germany requires an additional mass spectrometer to accommodate an expanded testing portfolio and ensure timely analysis of congenital diseases.

In September 2025, Laboratoire national de santé issued a Mass Spectrometry Analyzer Supply notice to acquire a combined HPLC and mass spectrometer for newborn screening, together with related maintenance services for a minimum of four years after warranty. The focus there is on the instrument itself and its long-term upkeep, underlining how central mass spectrometry has become to the reliability of screening programmes.

October 2025 saw further investment in neonatal screening capacity. Dirección General de Gestión Económica, Contratación e Infraestructuras de la Conselleria de Sanidad launched an Acquisition for Neonatal Screening project to buy a tandem mass spectrometer, an integrated immunoassay analyser and two thermocyclers to enhance the neonatal screening programme at the University and Polytechnic Hospital of La Fe. Just days earlier, on 22nd October 2025, Gerencia Fundación para la Investigación de Málaga en Biomedicina y Salud (FIMABIS) had advertised a Genetic Disease Detection Kits Contract, seeking kits for early detection of genetic diseases in newborns and equipment for processing dried blood samples as part of the MetabPlus research project.

Mass spectrometry is also moving deeper into other specialist areas. On 5th December 2025, Göteborgs universitet published a Monoclonal Gammopathies Monitoring System tender for a system to measure M-components in serum using MALDI-ToF mass spectrometry with automated processing and CE IVDR certification for patients with multiple myeloma. Although not a neonatal application, it shows how hospitals and universities are looking to mass spectrometric systems that meet in vitro diagnostic regulatory standards and can be embedded into routine patient monitoring.

Unlike these equipment-heavy tenders, the Instytut Matki i Dziecka notice concentrates on the consumable side of testing. The short text refers to kits for use with tandem mass spectrometry, but does not describe any associated instrument purchase or service package.

Genetic and molecular diagnostics embedded in public tenders

The newborn screening contract also fits into a broader pattern of public buyers specifying ever more detailed requirements for genetic and molecular diagnostics. In July 2025, Krajowe Centrum ds. AIDS released a Medical Devices for Cytometric Diagnostics notice for CE IVD reagent kits to identify and quantitatively assess CD3/CD4 and CD3/CD8 lymphocytes, along with storage and shipment services, to support HIV/AIDS patient monitoring as part of a government health programme.

On 18th July 2025, Samodzielny Publiczny Zakład Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodzi advertised a Supply of Genetic Testing Reagents contract for reagents and consumables used in genetic tests related to familial hypercholesterolaemia for a medical genetic laboratory, requiring strict compliance with specified requirements. A week later, on 25th July 2025, Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy Oddział w Gliwicach issued a Molecular Diagnostic Products Procurement tender for successive deliveries of diagnostic products, nucleic acid isolation sets, pDNA calibrators and consumables, divided into three tasks.

These oncology and cardiovascular genetics tenders are mirrored by broader framework-style procurements. In August 2025, Semmelweis Egyetem launched a Purchase of Reagents procedure to set up a framework agreement for a wide range of reagents and antibodies, with bidders required to price all items within each of nine lots. By December 2025, Natsionalen tsentar po zarazni i parazitni bolezni had gone to market for Laboratory Reagents and Consumables covering 36 separate positions, from kits for DNA/RNA isolation, PCR and sequencing to general laboratory supplies, with detailed documentation required from manufacturers.

Infections and routine laboratory medicine are following a similar path. In November 2025, Aktsiaselts Lääne-Tallinna Keskhaigla published a Laboratory Reagents and Supplies tender for reagents and supplies based on its testing needs, including panels for dermatophytes, meningitis and autoimmune myositis, as well as rapid tests for SARS-CoV-2 and influenza. On 26th November 2025, Szpital Uniwersytecki w Krakowie set out a Supply of Reagents and Equipment contract combining reagents, consumables and the leasing of apparatus and a water treatment station for its Department of Biochemical and Molecular Diagnostics.

Taken together, these notices show public buyers treating diagnostic reagents, consumables, equipment and associated services as strategic assets rather than incidental supplies. The Instytut Matki i Dziecka newborn screening tender is one of the more targeted examples, focused on a defined group of rare lysosomal storage disorders but clearly framed within the same move towards more precise, technology-specific laboratory contracts.

Bundled equipment, services and what it means for newborn screening

Recent procurements also highlight how laboratories are bundling equipment, reagents, training and service into integrated deals. On 14th July 2025, Miskolci Egyetem issued a Medical Laboratory Equipment Procurement for a new urine testing machine that must deliver multiple wavelength measurement, digital export of results, IVD CE certification, and come with necessary accessories and training. In September 2025, Budapest Főváros XV. kerületi Önkormányzat Dr. Vass László Egészségügyi Intézmény launched a Laboratory Reagents Procurement that requires bidders to provide automated devices for immunochemical and clinical chemical tests, install and maintain them, and supply reagents from the same manufacturer as the devices.

On 22nd September 2025, Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház-Rendelőintézet followed a similar integrated approach in its Laboratory Diagnostic Materials Procurement notice, combining diagnostic materials and supplementary items with device rental, maintenance, training and 24/7 service, ordered monthly against base and optional quantities. For suppliers, these models create long-term relationships built around specific analytical platforms, with reagent choices tied closely to the hardware installed in the laboratory.

By contrast, the Instytut Matki i Dziecka newborn screening notice, as summarised, focuses squarely on kits for use with tandem mass spectrometry. It sits alongside instrument-focused procurements such as those at Universitätsklinikum Magdeburg A.ö.R. and the University and Polytechnic Hospital of La Fe, illustrating how neonatal screening capacity is being built up through a series of linked but distinct contracts for equipment, kits and supporting services.

Outlook: how newborn screening portfolios may grow

The publication of the newborn screening kits tender on 31st December 2025 marks a clear statement of intent to incorporate Pompe, Fabry and Gaucher diseases and mucopolysaccharidosis type I into a mass spectrometry-based screening workflow at Instytut Matki i Dziecka. The eventual contract award will show which suppliers and platforms are selected to deliver that capability. Set against a year that has seen new mass spectrometers for newborn screening, genetic disease detection kits and large-scale reagent frameworks, the outcome will help indicate how quickly tandem mass spectrometry moves from specialist technology to an everyday part of public-sector newborn care.

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