Fulgent Genetics

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. 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.

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. 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. 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. 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.

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. After receiving this authorization, Fulgent went on to provide contracted testing services to a variety of states, counties, and school systems. The company was also awarded a CDC contract in 2021 to study COVID-19 variants.

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.

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. 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.

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.

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

Products and Business Lines

Genetic Testing

The company offers over 18,000 single gene tests and over 900 rare disease tests, as well as whole genome sequencing, mitochondrial sequencing, and reproductive health tests. The latter include Beacon Carrier Screening, a suite of panels designed to detect risk for early-onset conditions in an individual or reproductive pair's offspring, and KNOVA Prenatal Cell-Free DNA Screening, a non-invasive prenatal test that helps identify risk for certain genetic conditions in a baby by analyzing blood from a pregnant patient.

Fulgent Oncology

Fulgent’s Oncology somatic genetic testing services include the Lumera™ product line, which offer full genomic profiles of solid tumor tissue as well as hematological evaluations. Fulgent Oncology also offers germline cancer testing, pharmacogenetic testing, and specialty pathology services including immunohistochemistry, flow cytometry, cytogenetics, and fluorescent in situ hybridization (FISH).

BioPharma Services

The company’s BioPharma Services team provides Fulgent’s technology and expertise to academic and pharmacological teams in need of such services for their research. These services are offered globally and include next-generation sequencing, various pathology services, and other customizable services including multiplex immunofluorescence and Olink Proteomics.

Fulgent Pharma

Fulgent Pharma, which operated as an independent entity from 2016 but was reacquired by Fulgent in 2022, is a clinical stage pharmaceutical company focused on developing and commercializing cancer therapeutics. Currently they have two drugs in the clinical trial phase: FID-007 has been approved for phase II of clinical trials as of February 2024, and FID-022 has been approved for phase I of clinical trials as of January 2025.

At-Home Testing (Picture Genetics)

Picture Genetics is a service offered by Fulgent that provides clinician-supported genetic testing that consumers can order from home, receiving saliva collection kits in the mail and reports delivered online. Available tests include Picture Parenting, a carrier screening test to help identify one’s risk of passing on a genetic condition to their children; Picture Wellness, which can identify genetics-related lifetime risk for certain cancers and cardiovascular conditions in adults; Picture Newborn, which screens for rare, early-onset disorders in children for which early detection could improve the child's life; Picture PGx, which provides genetic insight on a person's ability to process various medications; and Picture PD Aware, which helps assess one’s risk for developing Parkinson’s Disease.

References

This article "Fulgent Genetics" is from Wikipedia. The list of its authors can be seen in its historical and/or the page Edithistory:Fulgent Genetics. Articles copied from Draft Namespace on Wikipedia could be seen on the Draft Namespace of Wikipedia and not main one.

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