🏢Abingdon Health Expands to the US with New Commercial Office and Laboratory
Abingdon Health plc, a prominent player in the lateral flow diagnostics industry, has announced the establishment of a new commercial office and R&D laboratory in the United States. This strategic expansion, expected to be completed by the end of 2024, is designed to enhance the company’s commercial capabilities and provide greater access to the US market.
🥼Scientific Overview
Lateral flow assays (LFAs) are simple, paper-based devices intended to detect the presence (or absence) of a target analyte in a sample without the need for specialized and costly equipment. These assays are widely used in various fields, including medical diagnostics, food safety, and environmental testing. Abingdon Health specializes in the development and manufacturing of these LFAs, offering services that range from product development and regulatory support to technology transfer and large-scale manufacturing.
The new US facility will significantly bolster Abingdon Health’s ability to support its clients in developing innovative diagnostic products. By providing a local base for operations, the company can offer more efficient and tailored services to its US customers, potentially accelerating the time-to-market for new diagnostic tools.
💡Opinion
This expansion is a strategic move that positions Abingdon Health to better serve the growing demand for rapid diagnostic solutions in the US. The establishment of a local office and laboratory not only demonstrates the company’s commitment to its clients but also highlights its proactive approach to market expansion. By investing in local infrastructure, Abingdon Health can enhance its service offerings and foster closer relationships with its US-based clients.
Chris Yates, CEO of Abingdon Health, emphasized the significance of this move:
“As a CRO/CDMO focused on lateral flow technology, we are well-placed to support a broad range of customers. The new US office and laboratory will enable us to offer more comprehensive services and strengthen our presence in a key market.”
This development follows a series of strategic acquisitions and investments, including the acquisition of IVDeology and Compliance Solutions (Life Sciences), which have expanded the company’s regulatory service offerings. The recent £5.6 million fundraise further underscores Abingdon Health’s commitment to growth and innovation.
In conclusion, Abingdon Health’s expansion into the US market is a forward-thinking strategy that will likely yield significant benefits for the company and its stakeholders. By enhancing its capabilities and presence in a key market, Abingdon Health is well-positioned to continue its growth trajectory and deliver value to its customers and shareholders alike.
✅ Yourgene Health’s Cystic Fibrosis Assay Achieves IVDR Certification
Yourgene Health, a leading international molecular diagnostics group and part of the Novacyt group of companies, has announced that its Cystic Fibrosis Base assay has received accreditation under the new EU In Vitro Diagnostic Regulation (IVDR). This certification marks a significant milestone for the company, ensuring the assay meets stringent quality, safety, and performance standards.
🥼Scientific Overview
The Yourgene Cystic Fibrosis Base assay is a Class C in vitro medical device designed for use by healthcare professionals within molecular laboratory environments. It employs amplification-refractory mutation system technology and genetic analyzers to detect point mutations, insertions, or deletions in DNA. This assay is crucial for various diagnostic scenarios, including carrier screening, newborn screening, and male factor infertility testing.
Cystic fibrosis (CF) is the most common life-shortening hereditary genetic condition, affecting approximately 1 in 2,500 live births among Caucasians. Early detection and diagnosis are vital, as they enable timely intervention and management of the disease. The Yourgene Cystic Fibrosis Base assay identifies patients with any of the 50 most common CF mutations in the European population, providing a reliable tool for clinicians.
💡Opinion
Achieving IVDR certification is a testament to Yourgene Health’s commitment to quality and innovation in molecular diagnostics. This accreditation not only enhances the credibility of the Cystic Fibrosis Base assay but also provides clinicians and patients with additional confidence in the test’s accuracy and reliability. As one of the first IVDR-certified CF tests on the market, it sets a high standard for diagnostic tools in this field.
Lyn Rees, CEO of Novacyt, highlighted the importance of this achievement:
“Conformity with IVDR provides clinicians and patients with additional confidence in the high-quality and accuracy of our test, which is increasingly becoming an essential tool in the detection and diagnosis of CF. With increasing momentum in this market, the IVDR accreditation further validates the quality of our test within the EU and beyond.”