Thermo Fisher Scientific Updates Applied Biosystems QuantStudio 5 Dx Real-Time PCR System to Comply with IVDR Regulations
7.6.2022 15:00:00 EEST | Business Wire | Press release
To help molecular diagnostic manufacturers and clinical testing laboratories adapt to higher-standard In Vitro Diagnostic Requirements (IVDR) now in effect in the European Union, Thermo Fisher Scientific is offering an IVDR version of the Applied Biosystems QuantStudio 5 Dx Real-Time PCR System globally. The innovative qPCR system simplifies molecular diagnostic workflows for infectious disease and oncology.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220607005144/en/
The IVDR-compliant QuantStudio 5 Dx System simplifies molecular diagnostic workflows for infectious disease and oncology. (Photo: Business Wire)
Molecular diagnostic kit manufacturers and clinical testing labs that develop their own assays need open qPCR platforms that meet IVDR requirements. The IVDR-compliant QuantStudio 5 Dx System will enable molecular diagnostic manufacturers to develop new IVDR-compliant tests under the new regulations. The system will also help clinical labs running diagnostic tests switch to IVDR qPCR testing.
“Molecular diagnostic manufacturers and laboratories that lack appropriately validated and CE-labelled instruments and tests may face delays under the new IVDR regulations,” said Marty Murawski, vice president, regulatory and quality assurance, at Thermo Fisher Scientific. “We are committed to helping our customers maintain high patient safety standards, meet new requirements, and obtain proper accreditation to remain competitive in today’s market. By making the Applied Biosystems QuantStudio 5 Dx Real-Time PCR System IVDR-compliant, we can now provide a high-performance, reliable qPCR system to support new testing workflows.”
Among the system’s updates, the multi-mode software is now IVDR compliant, providing dual functionality for running diagnostic tests and developing new assays in today’s regulatory environment. The qPCR system comes with an intuitive touchscreen and simplified, efficient workflow that minimizes steps to deliver quality results in as little as 30 minutes. In addition, a security, auditing, e-signature module provides secure operation.
The updated QuantStudio 5 Dx Real-Time PCR System is available in all regions that recognize CE-IVD certification and is also listed with the U.S. Food and Drug Administration (FDA).
For more information, please visit www.thermofisher.com/quantstudio5dx.
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For more information, please visit www.thermofisher.com.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220607005144/en/
Contact information
Media:
Mauricio Minotta
Phone: 760-805-5266
Email: mauricio.minotta@thermofisher.com
Jen Heady
Phone: 413-237-5141
Email: jheady@greenough.biz
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
IQM Appoints Craig Ciesla, Former Illumina VP, as CTO; Inés de Vega Becomes Chief Scientist19.6.2026 10:00:00 EEST | Press release
IQM Quantum Computers, the global leader in superconducting quantum computers, today announced the appointments of Dr. Craig Ciesla as Chief Technology Officer (CTO) and Dr. Inés de Vega as Chief Scientist, as she transitions from her role as Vice President of Quantum Solutions, deepening IQM´s leadership as the company prepares for its planned Nasdaq listing through a merger with Real Asset Acquisition Corp. (Nasdaq: RAAQ). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260619693929/en/ From left to right: Dr. Inés de Vega, Chief Scientist, and Dr. Craig Ciesla, Chief Technology Officer. Ciesla, an experienced deep tech executive with more than 25 years delivering products across multiple industries from startups to Fortune 500 companies, will advance IQM's technology strategy and drive its implementation into systems and products. De Vega, meanwhile, will be responsible for ensuring scientific feasibility and system-level
Teijin Receives Approval for Additional Indications of XEOMIN ® for Cervical Dystonia and Blepharospasm in Japan19.6.2026 10:00:00 EEST | Press release
Teijin Pharma Limited, the core company of the Teijin Group’s healthcare business, and Merz Therapeutics GmbH, a leading player in neurology-focused specialty pharma, jointly announced today that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved the additional indications for XEOMIN® (incobotulinumtoxinA) for the treatment of cervical dystonia and blepharospasm. This approval represents the fourth and fifth indications for XEOMIN® authorized in Japan, alongside its existing approvals for the treatment of upper limb spasticity, lower limb spasticity and chronic sialorrhea. Cervical dystonia is a focal dystonia characterized by involuntary contractions of the neck muscles, resulting in abnormal or repetitive movements and postures.1 Blepharospasm is also a focal dystonia, characterized by excessive involuntary contractions of the muscles surrounding the eye.2 Both conditions significantly impact patients’ quality of life. The approval by MHLW is based on Phase III clinic
Incyte Japan Announces Approval of Minjuvi ® (tafasitamab) in Combination with Lenalidomide for the Treatment of Adults with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)19.6.2026 09:00:00 EEST | Press release
Incyte Biosciences Japan G.K. today announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Minjuvi® (tafasitamab) in combination with lenalidomide for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). “This approval provides a new option for patients in Japan living with relapsed or refractory DLBCL, an aggressive disease with historically limited treatment options,” said Yasuyuki Ishida, General Manager, Incyte Biosciences Japan. “We are committed to helping address critical unmet needs for patients and their families affected by this challenging cancer.” DLBCL is the most common subtype of non-Hodgkin lymphoma and is an aggressive malignancy of B lymphocytes. While many patients respond to initial therapy, outcomes remain poor for those with relapsed or refractory disease, particularly for patients who are not eligible for autologous stem cell transplant.1 The approval is based on results from the MOR208C203 Trial: L
Amazfit Introduces Helio Strap Pro, Bringing Body-Worn Movement Intelligence to HYROX and Hybrid Training18.6.2026 20:07:00 EEST | Press release
Amazfit, a leading global smart wearable brand owned by Zepp Health (NYSE: ZEPP), today announced Helio Strap Pro, a body-worn training system designed to help HYROX and hybrid athletes better understand how their bodies perform under load. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260618031434/en/ Amazfit Introduces Helio Strap Pro, Bringing Body-Worn Movement Intelligence to HYROX and Hybrid Training Building on the screen-free Helio Strap, Helio Strap Pro adds a dedicated waist-mounted motion sensor that captures core-body movement and stability during training. Combined with upper-arm heart-rate sensing and compatible Amazfit smartwatches, the system provides a more complete picture of cardio effort, movement quality and muscle load than wrist-based tracking alone. Helio Strap Pro represents the next evolution of Amazfit's Hybrid Training System, extending performance tracking beyond heart rate to help athletes bett
HyperLight Announces $80 Million Series C to Accelerate TFLN Deployment for AI Infrastructure18.6.2026 18:30:00 EEST | Press release
HyperLight Corporation (“HyperLight”), a leader in thin-film lithium niobate (TFLN) photonics, today announced the closing of an $80 million Series C financing round led by MediaTek. The round includes participation from UMC Capital, Jabil, Foxconn, EDBI (arm of SG Growth Capital, the investment platform of the Singapore Economic Development Board and Enterprise Singapore), CDIB-TEN Capital, and Qatar Investment Authority (QIA), as well as strategic investors from leading silicon IC and networking companies. Existing investors Summit Partners, The Engine, Foothill Ventures, and Xora Innovation continue to actively support the company’s growth. The financing brings together companies across the AI infrastructure value chain — including silicon ICs, foundry manufacturing, electronics manufacturing services, networking, and global infrastructure investment — reflecting broad ecosystem support for scaling TFLN photonics into production. “This financing is about more than capital — it is ab
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom