Fulgent Genetics receives CE certification for NGS testing system

CALIFORNIA - Fulgent Genetics, Inc. (NASDAQ:FLGT), a $549 million market cap diagnostics company, announced Thursday it has received CE certification under the European Union’s In Vitro Diagnostic Regulation for its germline next-generation sequencing system, which includes FulgentExome and Fulgent Pipeline Manager. According to InvestingPro analysis, the company maintains a strong financial position with a current ratio of 6.32, indicating robust liquidity to support its expansion plans.

The certification, granted by TÜV SÜD, allows the company to market its diagnostic testing system throughout Europe. According to the company’s statement, Fulgent may be the first laboratory to receive CE mark for a comprehensive end-to-end germline testing offering that covers more than 4,600 genes validated for diagnostic use. The news comes as InvestingPro data shows the stock trading below its Fair Value, suggesting potential upside opportunity despite a 7.72% decline in the past week.

FulgentExome is designed to examine coding regions and splice junctions for these genes, reporting variants with potential clinical relevance. The system uses next-generation sequencing to identify germline variants that may aid in diagnosing suspected genetic conditions based on a patient’s clinical and family history.

"This achievement reflects our unwavering commitment to scientific excellence, patient safety, and regulatory compliance," said Harry Gao, Fulgent’s Chief Scientific Officer, in the press release.

Brandon Perthuis, Fulgent’s Chief Commercial Officer, noted that the certification may help ensure eligibility for reimbursement pathways for public health programs under IVDR.

Fulgent Genetics describes itself as a technology-based company with laboratory services and therapeutic development businesses. The company’s laboratory services include technical testing and professional interpretation of results by licensed physicians.

The announcement was made via a press release issued by the El Monte, California-based company. While analysts forecast challenging near-term profitability, detailed analysis and additional insights are available in the comprehensive Pro Research Report, one of 1,400+ company deep-dives available exclusively on InvestingPro.

In other recent news, Fulgent Genetics reported a notable earnings surprise for the first quarter of 2025, with earnings per share (EPS) reaching $0.04, significantly exceeding the analyst forecast of -$0.08. The company’s revenue for the quarter was $73.5 million, slightly below expectations, but it maintained a strong cash position of $814.6 million. Additionally, Fulgent Genetics held its 2025 Annual Meeting of Stockholders, where four directors were elected, and Deloitte & Touche LLP was ratified as the independent registered public accounting firm for the fiscal year. During the meeting, stockholders also approved, on a non-binding advisory basis, the compensation of the company’s named executive officers. Despite the strong Q1 performance, the company issued conservative guidance for the remainder of 2025, with expectations of a 10% year-over-year growth in core revenue. The company is also focusing on strategic investments and potential mergers and acquisitions (M&A) opportunities. Notably, analysts from firms like UBS and Piper Sandler have shown interest in the company’s strategic direction and capital deployment plans, including stock buybacks and potential M&A activities.

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