Thermo Fisher Scientific Updates Chromosomal Microarray Analysis Solutions to Comply with IVDR Regulation
31.5.2024 09:00:00 EEST | Business Wire | Press release
Thermo Fisher Scientific Inc., the world leader in serving science, announced today that the Applied Biosystems™ CytoScan™ Dx Assay and Applied Biosystems™ Chromosomal Analysis Suite (ChAS) Dx software now comply with In Vitro Diagnostic Regulations (IVDR) 2017/746 in the European Union. These compliance updates will enable cytogenetics testing laboratories to adapt to the latest medical device safety and efficacy frameworks and conformity assessments.
“Thermo Fisher’s unparalleled commitment to driving innovation in chromosomal microarrays has led to advancement of cytogenetic testing capabilities,” said Kevin Lowitz, vice president and general manager, microarray, at Thermo Fisher Scientific. “The compliance updates to the CytoScan Dx Assay kit and ChAS Dx software provide our customers in the EU with solutions that can help them maintain high patient safety standards and meet EU IVD regulatory requirements.”
Advancements in chromosomal microarrays (CMAs) have greatly expanded the capabilities of cytogenetics testing in recent years, including the ability to yield insights into genetic risk factors and disorders that are essential to understanding reproductive health. As an in vitro diagnostic CMA test for postnatal analysis, the CytoScan Dx Assay aids in the identification of underlying genetic causes of neurological and dysmorphic disorders in children. The assay enables users to accurately detect numerous chromosomal variations at higher resolution and greater coverage than conventional methods. It has demonstrated to improve diagnostic yield by an incremental 12.5% compared to G-banded karyotyping.
ChAS Dx is a powerful, intuitive software that simplifies cytogenetic analysis, visualization, and reporting of chromosomal aberrations across the genome. ChAS Dx provides whole-genome support for CytoScan Dx Arrays with flexible parameters and data formats, as well as direct access to multiple leading external genetic databases. The advanced data analysis software is available to all CytoScan Dx customers at no additional cost.
The complete IVDR compliant CytoScan Dx Cytogenetics Suite is a sample to insight solution that includes the CytoScan Dx Array, a reagent kit, the Applied Biosystems™ GeneChip™ System 3000 Dx platform for array processing, and user-friendly ChAS Dx software.
To learn more about the complete IVDR compliant CytoScan Cytogenetics Suite, please visit www.thermofisher.com/microarrayivd.
For In Vitro Diagnostic Use.
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $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/20240530659960/en/
Contact information
Amanda Strickland
Thermo Fisher Scientific
Phone: +1 510-566-8921
E-mail: Amanda.strickland@ppd.com
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 Quantum Computers Becomes First European Quantum Computing Company Listed on a Major U.S. Exchange2.7.2026 17:47:00 EEST | Press release
IQM Quantum Computers (Nasdaq: IQMX) (“IQM”, “IQM Quantum Computers” or the “Company”), a global leader in full-stack superconducting quantum computers, today became a publicly traded company following the completion of its business combination with Real Asset Acquisition Corp. (“RAAQ”). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260702960460/en/ IQM Quantum Computers Becomes First European Quantum Computing Company Listed on a Major U.S. Exchange The company’s American Depositary Shares begin trading today on the Nasdaq Global Select Market under the ticker symbol “IQMX”. The listing marks a major milestone for IQM establishing the company as the first European quantum computing company listed on a major U.S. stock exchange. Due to the proceeds of the transaction, IQM maintains a strong pro forma cash position of EUR 337 million. IQM enters the public markets with strong commercial momentum and a rapidly expanding globa
GigaDevice Launches First GD24CL Series I²C EEPROM, Further Expanding Its Non-Volatile Memory Portfolio2.7.2026 17:00:00 EEST | Press release
GigaDevice, a leading semiconductor company specializing in Flash memory, 32-bit microcontrollers (MCUs), sensors, and analog products, announced today the launch of its new GD24CL series I²C EEPROM. The series delivers outstanding performance, comprehensive security protection mechanisms, and excellent reliability that addresses the stringent requirements for stable and long-term storage of critical configuration data. These offered features will benefit applications in industrial, energy, Internet-of-Things (IoT), data centers, and networking. As GigaDevice’s first EEPROM product series, the launch further enhances the company’s non-volatile memory portfolio and provides customers with more dynamic storage solutions. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260702394554/en/ GigaDevice Launches First GD24CL Series I²C EEPROM, Further Expanding Its Non-Volatile Memory Portfolio. The GD24CL series is designed with high
Medical University of Graz Enrolls First Patient in DEEPER CHALLENGE Trial Evaluating Spur ® Peripheral Retrievable Scaffold System in a Select CLTI Cohort2.7.2026 14:00:00 EEST | Press release
Reflow Medical, Inc. announces that the Medical University of Graz has enrolled the first patient in the DEEPER CHALLENGE clinical trial. This investigator-initiated, single-center, single-arm, prospective study, supported by a grant, investigates early vessel recoil following below-the-knee treatment using the Spur® Peripheral Retrievable Scaffold System in combination with a commercially available drug-coated balloon. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260701995624/en/ The study investigates early vessel recoil following below-the-knee treatment using the Spur® Peripheral Retrievable Scaffold System in combination with a commercially available drug-coated balloon. The study plans to enroll up to 40 patients with chronic limb-threatening ischemia (CLTI) across two distinct cohorts: patients with diabetes and patients with end-stage renal disease receiving hemodialysis for at least six months, with women comprisi
Compass Pathways Announces New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)2.7.2026 13:30:00 EEST | Press release
Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, announced today that Compass granted equity awards under the Compass Pathways plc 2026 Inducement Plan to eight newly hired non-executive employees. The equity awards were granted on July 1, 2026 and consisted of options to purchase an aggregate of 63,685 shares and restricted share units or, in the case of employees in the United Kingdom nominal cost options, covering an aggregate of 30,300 shares. The options have an exercise price per share equal to $13.29, the closing price of the Company’s American Depositary Shares on the Nasdaq Global Select Market on the grant date, and will vest over a four-year period with 25% vesting on the first anniversary of the date of the grant and the remaining 75% vesting in equal monthly installments over the three-year period thereafter, subject to each employee’s continued employment. The restricted sh
Infobip Launches PitchMate — An AI Fan Companion for Global Football2.7.2026 13:00:00 EEST | Press release
Global AI-first cloud communications platform Infobip launched PitchMate, a new AI-powered conversational agent that brings football fans closer to the action of the world’s biggest football tournament. Purpose-built for the global football audience, PitchMate joins the TGR Haas F1 Team RaceMate — Infobip’s AI fan engagement solution for the TGR Haas F1 Team — in demonstrating how conversational AI is transforming fan engagement across sports worldwide. RaceMate, launched last April for this year’s motorsport season, is an AI agent on WhatsApp and Apple Messages for Business that puts TGR Haas F1 Team fans at the center of the action. It delivers real-time race data, personalized content, team radio highlights, trivia, and native multilingual support, turning passive viewers into active participants through natural, human-like conversations across every race weekend. Since its launch, RaceMate has reached users in more than 60 countries, achieving more than 40,000 messages exchanged wi
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