• The ELITe BBV panel was launched in 2022 and comprises three quantitative IVD assays targeting Human Immunodeficiency virus-1 (HIV-1), Human Hepatitis B Virus (HBV), and Human Hepatitis C Virus (HCV)

Turin, June 13, 2024: ELITechGroup is proud to announce today the successful approval of its BBV Panel for the Japanese market. ELITechGroup offers a fully automated PCR solution to test the BBV panel, which includes quantitative assays for monitoring of Human Immunodeficiency Virus (HIV-1), Human Hepatitis B Virus (HBV), and Human Hepatitis C Virus (HCV). The HBV and HCV assays received approval under Japan’s Pharmaceuticals and Medical Devices Act (PMDA) in March, followed by the HIV-1 assay in June.
Japan’s PMDA is renowned for its rigorous registration process for foreign in vitro diagnostic (IVD) manufacturers, making this approval a reflection of the high-quality standards of ELITechGroup’s IVD products.

The BBV assay panel has been validated in Japan in combination with the ELITe InGenius, sample-to-result instrument.
Since its launch at the end of 2022, ELITechGroup has partnered with reference laboratories to evaluate the performance of its panel against market benchmark assays demonstrating excellent performances.

This announcement underscores a crucial milestone in ELITechGroup’s mission to provide state-of-the-art diagnostic solutions, further solidifying its determination for the global relevance of high-quality molecular diagnostic solutions.

About ELITechGroup 

ELITechGroup, part of Bruker Corp.,is an integrated in-vitro diagnostics company that serves hospitals and diagnostic laboratories in more than 100 countries. The company develops, manufactures, and markets a wide range of diagnostic products and solutions – instruments, reagents, and software.

ELITech Molecular Diagnostics (MDx) serves the needs of clinical and research laboratories by offering a wide range of molecular diagnostic products, including nearly 60 CE-IVD assays and instruments as well as software applications.

Turin, Italy – May 29, 2024 – ELITechGroup is pleased to announce that they have obtained the IVDR certification for four new products including the brand new CMV RNA ELITe MGB Kit.
With the acquisition of this certification, ELITechGroup continues accelerating IVDR transition for the class C products for infectious diseases. This class includes all quantitative tests for infectious diseases follow up in transplant patients, such as the ELITe MGB CMV monitoring assay.

This significant milestone underscores ELITechGroup’s commitment to delivering high-quality and reliable diagnostic solutions to healthcare professionals worldwide. This achievement not only validates the rigorous standards the company adheres to in its product development but also reinforces its dedication to improving patient care through advanced diagnostic technologies.

ELITechGroup continues to lead the way in the development and commercialization of innovative diagnostic solutions, ensuring compliance with the highest regulatory standards.

About ELITechGroup 

ELITechGroup, part of Bruker Corp.,is an integrated in-vitro diagnostics company that serves hospitals and diagnostic laboratories in more than 100 countries. The company develops, manufactures, and markets a wide range of diagnostic products and solutions – instruments, reagents, and software.

ELITech Molecular Diagnostics (MDx) serves the needs of clinical and research laboratories by offering a wide range of molecular diagnostic products, including nearly 60 CE-IVD assays and instruments as well as software applications.

ELITechGroup announces the introduction of GI Parasitic PLUS ELITe MGB® Kit, the second addition to its gastrointestinal infection assay portfolio. Designed exclusively for diagnosing gastrointestinal parasitic infections, the kit targets Giardia lamblia, Cryptosporidium spp., Entamoeba histolytica, Encephalitozoon intestinalis, and Enterocytozoon Bieunesi. These pathogens are key contributors to gastrointestinal diseases resulting from food and water contamination, significantly impacting children, immunocompromised individuals, and global travelers. 

The kit is validated with ELITe InGenius and ELITe BeGenius sample-to-result instruments and designed to deliver precision diagnostics of human stool specimens. The fully automated process associated with the GI Parasitic PLUS ELITe MGB® Kit, spanning from extraction to result interpretation, has obtained IVDR certification, reaffirming ELITechGroup’s steadfast dedication to upholding the utmost standards of quality. 

Last month, ELITechGroup introduced its first kit of the GI infection assay portfolio: the GI Bacterial PLUS ELITe MGB® Kit. The company is geared to launch two additional in vitro diagnostic kits for Gastrointestinal Infections, targeting the viral parasites: the GI Viral PLUS ELITe MGB® Kit and the GI Norovirus PLUS ELITe MGB® Kit.  

These forthcoming launches are designed to offer a comprehensive solution for managing life-threatening gastrointestinal infections, marking a significant milestone in ELITechGroup’s mission to deliver state-of-the-art diagnostic solutions.
 

About ELITechGroup 

ELITechGroup is an integrated in-vitro diagnostics company that serves hospitals and diagnostic laboratories in more than 100 countries. The company develops, manufactures, and markets a wide range of diagnostic products and solutions – instruments, reagents, and software.

ELITech Molecular Diagnostics (MDx), one of the four business units of ELITechGroup, serves the needs of clinical and research laboratories by offering a wide range of molecular diagnostic products, including nearly 60 CE-IVD assays and instruments as well as software applications.

“The joint alliance between ELITechGroup and AIRC was created with the aim of promoting oncology research in the Piedmont region,” says Roberto Meda, Managing Director of ELITechGroup. ”The fight against cancer represents a collective challenge of which we want to be an active part: together we can fuel hope, promote awareness and help build the future of research.”

AIRC Foundation offers support to more than 6,000 researchers who choose to start a career in oncology research, as in the case of the ELITechGroup-funded fellowship.

“I am grateful to ELITechGroup, which as part of its charity program has enabled AIRC to activate the Fellowship that will allow me to bring what I learned at Oxford University back to a context of excellence such as Turin,”- comments Dr. Serafini, fellowship holder at the University of Turin, Department of Drug Technology.

ELITechGroup sostiene la ricerca di Fondazione AIRC finanziando una borsa di studio biennale per una giovane ricercatrice

ELITechGroup supporta la ricerca sul cancro finanziando una borsa di studio biennale post-doc, assegnata da Fondazione AIRC alla Dottoressa Marta Serafini, giovane ricercatrice impegnata da due anni all’Università di Oxford nella creazione di nuovi farmaci antitumorali.

Grazie al sostegno di ELITechGroup, la Dottoressa Serafini potrà rientrare in Italia e lavorare al progetto “Sfruttare i ridotti livelli di ossigeno per attivare selettivamente farmaci antitumorali” presso il Dipartimento di Scienza e Tecnologia del Farmaco dell’Università degli Studi di Torino.

“L’alleanza comune tra ELITechGroup e AIRC nasce con l’obiettivo di promuovere la ricerca oncologica nel territorio piemontese – afferma Roberto Meda, A.D. di ELITechGroup –. La lotta contro il cancro rappresenta una sfida collettiva di cui vogliamo essere parte attiva: insieme possiamo alimentare la speranza, promuovere la consapevolezza e contribuire a costruire il futuro della ricerca”.

Fondazione AIRC sostiene con continuità circa 6000 ricercatori e dedica particolare attenzione alla crescita e alla formazione dei giovani talenti della scienza oncologica con progetti specifici come nel caso della borsa di studio finanziata da ELITechGroup.

“Sono grata ad ELITechGroup che nell’ambito del proprio programma di charity ha permesso ad AIRC di attivare la Borsa di Studio che mi consentirà di riportare quanto ho imparato all’Università di Oxford in un contesto di eccellenza come quello di Torino “– commenta la dottoressa Serafini, titolare della borsa di studio presso l’Università degli Studi di Torino, Dipartimento di Scienza e Tecnologia del Farmaco.

In a significant move towards advancing global diagnostic capabilities, ELITechGroup proudly announces the introduction of the GI Bacterial PLUS ELITe MGB^® Kit, a robust addition to its diagnostic portfolio. Tailored specifically for diagnosing gastrointestinal bacterial infections, the in vitro assay exclusively targets major bacterial pathogens including Campylobacter spp., Clostridium difficile, Salmonella spp., Shigella spp., and Yersinia enterocolitica. These pathogens are widely acknowledged as significant contributors to global food and waterborne, as well as hospital-acquired, gastrointestinal infections.

The entire process underlying the GI Bacterial PLUS ELITe MGB® Kit, from extraction to result interpretation, has achieved CE-IVDR certification, underscoring ELITechGroup’s unwavering commitment to the highest standards of quality. Fully validated with ELITe InGenius and ELITe BeGenius sample-to-result instruments, the kit is designed to deliver precision diagnostics of human stool specimens.

Aligning with the company’s dedication to precision molecular diagnostics, ELITechGroup is set to launch three more in vitro diagnostic kits for Gastrointestinal Infections, covering parasitic and viral pathogens- GI Parasitic PLUS ELITe MGB® Kit, GI Viral PLUS ELITe MGB® Kit, and GI Norovirus PLUS ELITe MGB® Kit.

These new launches aim to provide a comprehensive solution for the management of life-threatening gastrointestinal infections marking a pivotal milestone in ELITechGroup’s mission to provide state-of-the-art diagnostic solutions.

About ELITechGroup

ELITechGroup is an integrated in-vitro diagnostics company that serves hospitals and diagnostic laboratories in more than 100 countries. The company develops, manufactures, and markets a wide range of diagnostic products and solutions – instruments, reagents, and software.

ELITech Molecular Diagnostics (MDx), one of the four business units of ELITechGroup, serves the needs of clinical and research laboratories by offering a wide range of molecular diagnostic products, including nearly 60 CE-IVD assays and instruments as well as software applications.

Redesigned for PCR efficiency and biplex compatibility

Bothell, WA, November 7, 2023 — ELITechGroup MDx LLC (EGMDx) announced availability of their redesigned enterovirus and parechovirus analyte specific reagents^* (ASR). The ASRs are designed to be used in the development of real-time PCR assays and were reengineered for both performance and workflow functionality. The two sets of reagents are now optimized for singleplex PCR efficiency and biplex compatibility, offering greater flexibility for clinical and research laboratories.

The company projects that many children’s hospitals will appreciate their enterovirus and parechovirus real-time PCR design improvements. Viral meningitis is a concern among children’s hospitals, with diagnostic testing for enterovirus in cerebrospinal fluid specimens by PCR recognized as the gold standard. For this pediatric patient population, clinicians also frequently consider and order parechovirus testing. The company notes that with regard to enterovirus respiratory testing, their probe retains its ability to detect Enterovirus D68.

“Our newly released enterovirus and parechovirus reagents have been eagerly anticipated by several of our children’s hospital lab customers,” said Scott Johnston, General Manager. Johnston added, “R&D recently completed a redesign of our enterovirus and parechovirus ASRs. The new ASRs are optimized for improved PCR efficiency at lower copy numbers and minimal cross reactivity when biplexed. Lab workflow was also top of mind during product development. We wanted to offer a workflow solution for enterovirus and parechovirus testing, with automated extraction, amplification, and results. This automation is possible using our ELITe BeGenius® system. Alternately for lab flexibility, our reagents are compatible with many open channel systems and can help optimize the use of existing molecular lab equipment.”

The EGMDx product portfolio includes the following analytes of interest when testing patients suspected of viral meningitis:

• DSQ Alert Enterovirus v2.0 primer and probe ASRs
• DSQ Alert Parechovirus v2.0 primer and probe ASRs
• HSV 1&2 ELITe MGB® IVD Assay
• MGB Alert® VZV primer and probe ASRs
• MGB Alert HHV-6 primer and probe ASRs

^*Analyte Specific Reagent. Analytical and performance characteristics are not established.

About ELITechGroup MDx LLC

ELITechGroup MDx LLC serves the needs of clinical and research laboratories alike, offering an extensive range of molecular diagnostics products, including the fully automated sample-to-result ELITe BeGenius and ELITe InGenius instruments and a growing menu of infectious disease tests and reagents featuring innovative chemistries to optimize sensitivity and specificity. MGB Alert products utilize the original minor groove binder probe technology and offer the flexibility of PCR-based detection or melt curve analysis. DSQ Alert products feature the duplex stabilizing quencher, the latest evolution of hydrolysis probe-based real-time PCR. Other proprietary chemistries designed for optimum product performance include the original azo dye Eclipse® Dark Quencher, AquaPhluor® fluorescent dyes, and nucleobases Super A®, T, G, and I.

Contact
Scott Johnston, General Manager
Phone 925-495-9492
Email s.johnston@elitechgroup.com

This unsung hero has been a pivotal invention in the history of real-time PCR. It has been the key constitute of all our probes and is responsible for the high accuracy and sensitivity of all our assays. Further, the MGB-oligonucleotide complexes or MGB Probe has been a popular molecule of choice in the realm of molecular diagnostics.

The MGB molecule reversibly binds to the minor groove of double-stranded DNA in a stable configuration due to hydrophobic and Van Der Waals interactions. When linked to an oligonucleotide, MGB allows the formation of highly stable DNA duplex. The resulting highly stable complexes inhibit strand separation and prevent DNA processing and packaging functions. The increased stability of the DNA template / MGB-oligonucleotide duplex offers many advantages. These include:

• Allows design of shorter oligonucleotide probes: improving the mismatch discrimination efficiency and reducing the possibility for the formation of secondary structure and dimers among primer and probes
• Synergistic quenching with Eclipse Dark Quencher®: further decreasing background fluorescence and improving sensitivity with ELITechGroup MDx LLC best in class quencher molecule.
• Bringing fluorophore closer to quencher: decreasing background fluorescence and improving sensitivity
• Equalizing binding stability of A-T and G-C region: stabilizing the A-T-rich regions, reduces the influence of DNA sequence on the probe melting temperature (Tm).
• Opening doors to new assay designs: short target sequences, challenging A-T rich regions, polymorphic regions, and detection of mismatched variants

The impact of MGB-Probes extends across various fields, from infectious diseases to the detection of cancer markers. As a scientific community today, we celebrate the contribution of Mole as the foundation of chemistry. We also take the occasion to extend our gratitude and celebrate the contribution of the pioneering chemists of the ELITechGroup who laid the foundation for this groundbreaking technology.

Torino (Italy), 9th October 2023 – ELITechGroup, a leader in molecular diagnostics, announces the addition of new IVDR-certified PCR kits to its ever-growing portfolio.

The In Vitro Diagnostic Medical Devices Regulation (IVDR) came into force on May 26, 2022, raising the standard of diagnostic assays after the introduction of the In Vitro Diagnostics Directive (IVDD) in 1998. The new regulation applies to all manufacturers of in-vitro-diagnostic devices and is intended to ensure greater compliance, increased patient safety as well as testing efficiency.

In January 2023, ELITechGroup received its first IVDR certificate for class C antibiotic resistance testing. Today, the company added class B infectious disease tests such as Bordetella and gastrointestinal assays to its IVDR portfolio.

The achievement of the second IVDR milestone is a further demonstration of ELITechGroup’s commitment to supporting clinical laboratories worldwide with state-of-the-art assays. The company is on track to the full and timely transition from the In Vitro Diagnostics Directive (IVDD) to the In Vitro Diagnostic Medical Devices Regulation (IVDR) by the end of 2026.

About ELITech Group

ELITech Group is an integrated in-vitro diagnostics company that serves hospitals and diagnostic laboratories in more than 100 countries. The company develops, manufactures, and markets a wide range of diagnostic products and solutions – instruments, reagents, and software.

ELITech Molecular Diagnostics (MDx), one of the four business units of ELITech Group, serves the needs of clinical and research laboratories by offering a wide range of molecular diagnostic products, including nearly 60 CE-IVD assays and instruments as well as software applications.

ElitechGroup Mdx is pleased to announce that ELIVERSE will be launched in Europe in 2024.
With its introduction, ELITechGroup will have launched three molecular sample-to-result platforms in 8 years.

Read the press release here.

Copenhagen, 15th April 2023 – At the ECCMID congress ELITech Group unveiled the upcoming launch of a new high throughput sample-to-result instrument for molecular diagnostics.

In 2016 ELITechGroup introduced ELITe InGenius, its first sample-to-result system for molecular diagnostics. Since then, the company has been expanding the system’s menu to more than 50 CE-IVD parameters and has validated more than 20 sample matrices. BeGenius was launched in 2021 to address the needs of laboratories that require higher throughput.
To date, more than 1100 InGenius and BeGenius instruments have been installed across the globe. Users appreciate the broad menu as well as the instrument’s versatility and robustness.
Elitech MDx is committed to transitioning its complete portfolio of CE-IVD parameters to IVDR and has already received the first IVDR certificates for both InGenius and BeGenius.

The company’s new high throughput system will be based on ELITech’s proven extraction and assay technology. It will use the same reagents as InGenius and BeGenius. The instrument offers continuous loading of samples and reagents coupled with real random-access capability. The user will be able to run in parallel different PCR reagents, protocols, and sample matrices, with maximum versatility.
ELITech’s broad and expanding menu of IVD assays together with the instrument’s superior throughput and multiplexing capability will make it the ideal platform for laboratories with a high level of complexity in their routine testing.
The European launch of the new system is planned for the end of 2024.

With the introduction of its high throughput system, ELITechGroup will have launched three molecular sample-to-result platforms in 8 years. This track record demonstrates the company’s commitment to serving molecular laboratories worldwide with innovative instruments and state-of-the-art PCR assays – independent of their throughput needs.

About ELITech Group

ELITech Group is an integrated in-vitro diagnostics company that serves hospitals and diagnostic laboratories in more than 100 countries. The company develops, manufactures, and markets a wide range of diagnostic products and solutions – instruments, reagents, and software.

ELITech Molecular Diagnostics (MDx), one of the four business units of ELITech Group, serves the needs of clinical and research laboratories by offering a wide range of molecular diagnostic products, including more than 50 CE-IVD assays and instruments as well as software applications.