Draft:Fulgent Genetics

Biotech Company in US From Wikipedia, the free encyclopedia


Intro

Fulgent Genetics, Inc. is a genomic testing company headquartered in El Monte, California with multiple CLIA-certified and CAP-accredited laboratories in the United States[1]. Its laboratories mainly perform genetic testing and oncology diagnostic services for clinical clients, including services for oncology, anatomic pathology, rare disease, and reproductive health.

The company also has a therapeutic development business line, Fulgent Pharma, through which they are developing drug candidates for treating a broad range of cancers using a novel nanoencapsulation and targeted therapy platform.[2]

History

2011-2019: Founding, Initial Public Offering, and Expansion

The company was initially founded as Fulgent Therapeutics by Ming Hsieh and James Xie (previously of Cogent Systems) with an initial focus on cancer therapeutics.[3] The founders’ focus shifted to genetic testing via next-generation sequencing (NGS) with the arrival of Dr. Harry Gao (previously of City of Hope) in 2012.

In 2014, Fulgent Genetics became the first clinical laboratory to offer copy number variation detection using NGS technology in the United States. While their test offerings began with pediatric rare disease NGS analysis, at this time they began to expand to include genetic tests for a variety of medical disciplines, including reproductive medicine, oncology, cardiology, neurology, and others.

In September 2016, Fulgent became a public company via an initial public offering on the NASDAQ exchange.[4] In the following years the company continued to expand its genetic testing menu to include over 10,000 genes and over 170 genetic testing panels.

In 2019, Fulgent launched an at-home testing line called Picture Genetics, a service offering clinical-grade, at-home genetic tests for cancer and cardio risk assessment, carrier screening, and newborn screening.[5] Also in 2019, the company announced a collaboration with the Parkinson’s Foundation on a new genetic testing initiative for individuals living with Parkinson’s Disease.[6]

2020-2025: COVID-19 Response and Acquisitions

Fulgent launched COVID-19 testing in May 2020 by using their genetic testing resources to validate and perform viral RNA sequencing. Existing technology platforms allowed the company to expand testing rapidly, and it received FDA Emergency Use Authorization (EUA) for RT-PCR COVID-19 testing later that year.[7][8] After receiving this authorization, Fulgent went on to provide contracted testing services to a variety of states, counties, and school systems.[9][10][11][12][13][14] [15] The company was also awarded a CDC contract in 2021 to study COVID-19 variants.[16]

In August 2021, Fulgent acquired CSI Laboratories, expanding the company’s capabilities in molecular diagnostics and oncologic testing, including flow cytometry, cytogenetic analysis, fluorescence in-situ hybridization (“FISH”), immunohistochemistry, and molecular genetics.[17]

Fulgent went on to acquire Inform Diagnostics in April 2022, allowing the expansion of its test menu into anatomic pathology, including the subspecialties of breast pathology, gastrointestinal pathology, dermatopathology, urologic pathology, neuropathology, and hematopathology.[18][19] The acquisitions of both CSI Laboratories and Inform Diagnostics led to the integration of Fulgent Oncology, a line of business specializing in testing for clinical oncologists and pathologists.[20]

In November 2022, Fulgent acquired Fulgent Pharma Holdings, Inc. (“Fulgent Pharma”), a venture previously started by Fulgent’s founders to develop anti-cancer therapies using nanoencapsulation techniques. Fulgent Pharma had previously split from Fulgent Genetics as an entity in 2016, when the businesses were separated ahead of the Initial Public Offering of Fulgent Genetics, but was re-acquired to help achieve the company’s goal of providing comprehensive cancer care solutions.[21][22]

In August 2025, Fulgent acquired ANP Technologies under Fulgent Pharma to further expand its therapeutics IP portfolio.

Products and Business Lines

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