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.

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.

Candida auris detection reagents are commercially available for use in clinical and research laboratories

Bothell, WA, March 27, 2023 — ELITechGroup MDx LLC (EGMDx) announced availability of their Candida auris family of products, including reagents for C. auris detection, a multiplex of seven Candida pathogens, and C. auris with fluconazole resistance. This suite of real-time PCR products includes analyte specific reagents (ASR) and research use only (RUO) materials used by clinical and research laboratories.

The EGMDx product portfolio includes:

• DSQ Alert Candida auris primer and probe ASRs^*, for specific detection of auris
• MGB Alert^® Candida auris with fluconazole resistance RUO** Detection Reagent
• MGB Alert^® Candida species with C. auris RUO** Detection Reagent, for detection and discrimination of seven Candida species in a multiplex format

EGMDx initially released their Candida auris product family in February 2023. Product development efforts accelerated in response to a November 2022 publication from the World Health Organization, the WHO Fungal Priority Pathogens List. The WHO publication urges detection and surveillance for Candida pathogens and antifungal resistance.

In March 2023, the Centers for Disease Control published a warning in the Annals of Internal Medicine that cited a dramatic increase in the spread of C. auris between 2019 and 2021. The number of C. auris infections increased by 59%, to 756, from 2019 to 2020 and then by an additional 95%, to 1,471, in 2021. Findings state that C. auris has now been found in more than half of U.S. states. The CDC publication highlights the need for improved detection and infection control practices to prevent the spread of C. auris.

Up to 95% of all invasive Candida infections in the United States are caused by five species of Candida: C. albicans, C. glabrata, C. parapsilosis, C. tropicalis, and C. krusei. These five species and two additional targets, C. auris and C. dubliniensis, are detectable using the new Candida species multiplex from EGMDx.

 EGMDx is an innovative company that realizes the need for flexibility and versatility to optimize lab infrastructure and capacity. The release of their Candida family of products has been anticipated by many hospital laboratories, including lab partners involved in developing the products. “Our Candida auris family of reagents is compatible with many open channel systems and can help optimize molecular lab equipment,” said Scott Johnston, General Manager. Johnston added, “We’re proud to have an agile team that can quickly respond to clinical and public health needs.”

EGMDx reagents are compatible with the company’s proprietary ELITe BeGenius^® automated sample to result platform, in addition to third party open channel instrument systems. The company is a dedicated molecular diagnostics manufacturer offering reagents and instrument systems to detect infectious diseases.

Please visit www.elitechgroup.com/molecular-diagnostics-us to learn more.

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

^**For Research Use Only. Not for use in diagnostic procedures.

About ELITechGroup MDx LLC

ELITechGroup MDx 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 nucleotide Superbases.

Contact

Scott Johnston, General Manager

Phone 925-495-9492

Email s.johnston@elitechgroup.com

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A suite of Candida reagents is now commercially available for use in clinical and research laboratories

Bothell, WA, February 8, 2023 — ELITechGroup MDx LLC (EGMDx) announced the release of their Candida family of products, including reagents for C. auris detection, with fluconazole resistance, and a multiplex of Candida pathogens. This new suite of real-time PCR products includes analyte specific reagents (ASR) and research use only (RUO) materials used by clinical and research laboratories.

The newest additions to the EGMDx product portfolio include:

• DSQ Alert Candida auris primer and probe ASRs*, for specific detection of C. auris
• MGB Alert® Candida auris with fluconazole resistance RUO** Detection Reagent
• MGB Alert® Candida species with C. auris RUO** Detection Reagent, for detection and discrimination of seven Candida species in a multiplex format

EGMDx accelerated the launch of their Candida product family in response to a recent publication from the World Health Organization, the 2022 WHO Fungal Priority Pathogens List to Guide Research, Development And Public Health Action. The publication urges detection and surveillance for Candida pathogens and antifungal resistance.

C. auris, C. albicans, C. glabrata (Nakaseomyces glabrata), C. krusei (Pichia kudriavzevii), C. tropicalis, and C. parapsilosis are identified as priority pathogens by the WHO and are each detectable with these new reagents. Additionally, Aspergillus fumigatus, Mucorales, and Pneumocystis jirovecii are also listed as priority fungal pathogens and offered in the EGMDx portfolio. Notably, Cryptococcus neoformans is in development by the company’s research and development team. Once released, reagents for C. neoformans will round out the company’s offerings to detect the four WHO Critical Priority Group pathogens: C. neoformans, C. auris, A. fumigatus, and C. albicans.

According to the Centers for Disease Control and Prevention, the COVID-19 pandemic led to a marked increase in infections of antifungal-resistant C. auris and an overall increase in antifungal-resistant Candida, considered urgent and serious public health concerns, respectively. Up to 95% of all invasive Candida infections in the United States are caused by five species of Candida: C. albicans, C. glabrata, C. parapsilosis, C. tropicalis, and C. krusei. These five species and two additional targets, C. auris and C. dubliniensis are detectable using the new Candida species multiplex from EGMDx.

A dedicated molecular diagnostics manufacturer specializing in infectious diseases, EGMDx is an innovative company that realizes the need for flexibility and versatility to optimize lab infrastructure and capacity. The release of their Candida family of products has been anticipated by many hospital laboratories, including lab partners involved in developing the products. “Our new Candida reagents are compatible with most open channel systems and can help optimize underutilized molecular lab equipment, while answering the call for innovative antifungal diagnostics,” said Scott Johnston, General Manager. Johnston added, “We’re proud to have an agile team that can quickly respond to clinical and public health needs.”

The company’s MGB Alert hybridization probe products feature minor groove binder (MGB) probe technology which was originally invented by ELITechGroup and is now widely used throughout the clinical lab industry. Likewise, the company’s new duplex stabilizing quencher (DSQ) chemistry is now offered in their new DSQ Alert hydrolysis probe reagents. DSQ probes feature enhanced signal-to-noise fluorescence and DNA duplex stability, offered as the next evolutionary step in MGB probe chemistry. EGMDx reagents are compatible with the company’s proprietary ELITe BeGenius® automated sample to result platform, and on most open channel instrument systems.

Please visit us here to learn more.

*Analyte Specific Reagent. Analytical and performance characteristics are not established.
**For Research Use Only. Not for use in diagnostic procedures.

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 nucleotide Superbases.

Contact
Scott Johnston, General Manager
Phone +1 925-495-9492
Email s.johnston@elitechgroup.com

Copywriting by Stramasa

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Turin, 22nd December 2022 – ELITechGroup has inaugurated its new headquarters in Turin, becoming one of the largest molecular biology hubs in Europe.

The inauguration was held on Friday 16th December in the presence of institutional figures, collaborators, and employees.

At the ribbon cutting, Michela Favaro – Deputy Mayor of Turin – and Roberto Meda – ELITechGroup’s Senior Vice President responsible for Molecular Diagnostics.

The company, founded 30 years ago as a spin-off of the University of Turin, has established itself in the field of molecular biology moving from a local to a multinational reality.

“We are proud to inaugurate this new headquarters – said Roberto Meda – ELITechGroup’s Senior Vice President responsible for Molecular Diagnostics – It has been possible thanks to the company’s top-level scientific expertise, managerial courage, passion, and propensity for innovation. These have been the steps behind the strategic investments, which, together with the extraordinary human and professional qualities of the women and men in our company, have enabled us to achieve exceptional results, thus becoming a reference centre for molecular biology worldwide. A larger and more innovative hub where we will be able to better experience the company, with its new and modern spaces designed for a new social networking.”

About ELITechGroup

ELITechGroup is a privately held group of worldwide manufacturers and distributors of in vitro diagnostic equipment and reagents. By bringing together IVD specialty companies that offer innovative products and solutions, ELITechGroup has become a major contributor in advancing clinical diagnostics to laboratories in the proximity market, those operating closer to the patient.

ELITe InGenius nominated for Scientists’ Choice Awards!

Each year the Scientists’ Choice Awards^® celebrates the laboratory products and manufacturers that make a difference to the industry. SelectScience began the Scientists’ Choice Awards^® in 2007 to enable scientists to voice their opinions on the best laboratory products. Scientists are then invited to vote for their favorite products within each category, and the winners are announced at scientific conferences. This year ELITe InGenius was nominated for Best New Clinical Product of 2015 in a very competitive field of prestigious manufacturers and innovative instrumentation. Learn more at: http://www.selectscience.net/scientistschoiceawards/PRDetails.aspx?artID=41618#sthash.7hlBrUSz.dpuf For life science research only. Not for use in diagnostic procedures unless otherwise indicated”

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Bioperfectus launched the Monkeypox Virus Real Time PCR Kit with CE marking on May 24^th, 2022. Based on real-time PCR technology, the kit is specifically designed on the F3L gene areas of the monkeypox virus. In addition, the kit also contains a housekeeping gene (RNase P) as an internal control (IC) for specimen sampling and nucleic acid extraction.

BioPerfectus and ELITechGroup are collaborating to provide the BioPerfectus Monkeypox Virus Real Time PCR Kit exclusively for ELITe InGenius and BeGenius instruments to offer the first fully automated monkeypox diagnostic solution on the market. Both parties aim to support diagnostic capacity to fight the monkeypox outbreak.

According to the World Health Organization, real-time PCR is the preferred method for monkeypox virus surveillance given its accuracy and sensitivity. ELITechGroup is thrilled to gain Bioperfectus as a solid partner in monkeypox virus testing in Europe.

About ELITechGroup:

ELITechGroup S.p.A. is the headquarter of the Molecular Diagnostics division of ELITechGroup, which develops innovative molecular diagnostic solutions targeted for infectious diseases. By bringing together IVD specialty companies that offer innovative products and solutions, ELITechGroup manufactures and distributes diagnostic products for clinical chemistry, microbiology, hematology, and molecular biology through direct sales and a distribution network encompassing more than 100 countries. For more information, please visit www.elitechgroup.com.

About Bioperfectus:

Bioperfectus, a publicly listed company on the Shanghai Stock Exchange (SSE:688399), has been a leading molecular diagnostic solution provider specializing in infectious diseases since 2010. With headquarters in Jiangsu, and subsidiaries in Shanghai, Beijing, Xi’an, Taizhou, Hainan, and Yinchuan, Bioperfectus is a pioneer in the molecular diagnostics market with products ranging from real-time PCR kits, nucleic acid extraction systems, rapid tests, and automated laboratory devices. Young and passionate, Bioperfectus is working steadily and firmly to achieve the dream of creating a healthier future for our next generations. For more information, please visit www.bioperfectus.com.

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