Fulgent Genetics has obtained CE certification under the European Union’s (EU) In Vitro Diagnostic Regulation (IVDR) for its germline next-generation sequencing (NGS) system.
The system, which includes FulgentExome and Fulgent Pipeline Manager (PLM), features comprehensive diagnostic capabilities, validating over 4,600 genes for clinical use.
FulgentExome is designed to perform a patient-centric, phenotype-driven analysis, examining coding regions and splice junctions of more than 4,600 genes.
The system reports only variants with plausible clinical relevance, aiding in the diagnosis of suspected genetic conditions based on a patient’s clinical and family history.
Fulgent PLM, an in vitro diagnostic medical device software, supports the analysis of genetic information derived from sequencing data within the FulgentExome system.
Fulgent chief commercial officer Brandon Perthuis said: “With the CE mark, we can now make FulgentExome available to clinics and hospital systems throughout Europe, helping families get answers to complex clinical phenotypes.
“FulgentExome may be used as an inclusion test for clinical trials and may help ensure eligibility for reimbursement pathways for public health programs under IVDR.
“With excellent turnaround time and quality, we believe we can now present a compelling service offering in Europe. This CE mark is an important step towards growing our global business, especially in the EU.”
Fulgent Genetics, known for its robust laboratory services and therapeutic development business, offers technical laboratory and testing services.
The services include professional interpretation of laboratory results by licensed physicians, enhancing the company’s diagnostic offerings.
Earlier this year, Fulgent Genetics partnered with Foundation Medicine to launch two new germline tests in the US, FoundationOne Germline and FoundationOne Germline More.
Powered by Fulgent’s proprietary technology, the tests identify genetic variants linked to hereditary cancers and assess underlying risks for patients and their families.
The germline tests, when combined with Foundation Medicine’s genomic profiling (CGP) tests, enable healthcare providers to develop a detailed molecular profile for their patients.
Fulgent chief scientific officer Harry Gao said: “We are proud to announce that our germline next-generation sequencing (NGS) test has received CE certification from TÜV SÜD, which is a significant milestone in our mission to deliver comprehensive and high-quality genomic solutions for hereditary disease diagnosis in Europe.
“This achievement reflects our unwavering commitment to scientific excellence, patient safety, and regulatory compliance.”
