Fulgent Genetics, Inc., together with its subsidiaries, operates as a technology-based company with a well-established laboratory services business and a therapeutic development business.
The company’s laboratory services business includes technical laboratory services and professional interpretation of laboratory results by licensed physicians. The company’s therapeutic development business focuses on developing drug candidates for treating a broad range of cancers using a novel nanoencapsulat...
Fulgent Genetics, Inc., together with its subsidiaries, operates as a technology-based company with a well-established laboratory services business and a therapeutic development business.
The company’s laboratory services business includes technical laboratory services and professional interpretation of laboratory results by licensed physicians. The company’s therapeutic development business focuses on developing drug candidates for treating a broad range of cancers using a novel nanoencapsulation and targeted therapy platform designed to improve the therapeutic window and pharmacokinetic profile, or PK profile, of new and existing cancer drugs.
Laboratory Services Business
The company has broad testing capabilities with a testing and testing services menu that is scalable and affordable to its customers. The company’s testing and testing services include:
Comprehensive anatomic pathology testing services, including gastrointestinal pathology, dermatopathology, urologic pathology, breast pathology, neuropathology, and hematopathology. These services are supported by the company’s expansive geographic presence with Clinical Laboratory Improvement Amendments of 1988, or CLIA, licensed laboratories in the United States.
Precision diagnostics testing services include next-generation sequencing, or NGS, tests for biopharma research and clinical tests for rare disease, hereditary cancer, reproductive health, and many other disease subtypes. The company’s precision diagnostic testing also includes specialized oncology tests and testing services utilize a wide array of technologies. These services include flow cytometry; cytogenetic analysis; fluorescence in-situ, or FISH; immunohistochemistry; molecular genetics; NGS; and consultations in hematopathology and surgical pathology.
The company also offers testing services to pharmaceutical or biotech companies, contract research organization, or CROs, or sponsored testing programs, which it calls BioPharma services.
Picture is a patient-centric telemedicine platform that prioritizes patient convenience and education, giving consumers the power to initiate testing and access to clinical support. Picture tests help individuals identify important health markers to empower their personal health journey.
Laboratory Services Technology Platform
The company’s proprietary technology platform for its laboratory services business includes proprietary gene probes, data suppression and comparison algorithms, adaptive learning software, and proprietary laboratory information management systems. This platform provides a broad test menu, the ability to rapidly develop and launch new tests, customizable test offerings, lower cost per test, and high efficiency. As an example, this technology platform allowed the company to rapidly respond to the 2019 novel coronavirus disease, or COVID-19, pandemic and scale its business to provide COVID-19 tests with reliable results and rapid turnaround time in a way that surpassed even its largest competitors.
Therapeutic Development Business - Fulgent Pharma
In 2022, the company completed its acquisition of Fulgent Pharma Holdings, Inc., or Fulgent Pharma. The company’s efforts at Fulgent Pharma are based on a novel nano-drug delivery platform technology capable of delivering various water-insoluble or poorly soluble drugs. Nano-drug delivery, or nanoencapsulation, refers to a technology where active pharmaceuticals are encapsulated within miniature capsules to protect and control the release of these pharmaceuticals in a targeted manner. Unlike other nano-drug delivery materials such as Human Serum Albumin, which is only soluble in water, the company’s nano-drug delivery materials used for its drug candidates in development are soluble not only in water but also in various organic solvents, as well as capable of hot melt mixing with active pharmaceutical ingredients, or APIs.
Laboratory Services Customers
The company classifies its customers in its laboratory services business by their payor types: Insurance; Institutional, including hospitals, medical institutions, other laboratories, governmental bodies, payors, municipalities, and large corporations; and Patients who pay directly. Typically, the company bills its Institutional customers for its tests and testing services, and they are responsible for paying the company directly. A small percentage of the company’s customers are patients who elect to pay for tests or testing services themselves with out-of-pocket payments after their physicians have ordered the company’s tests or testing services.
Laboratory Services Sales and Marketing
The company’s sales and marketing force for its laboratory services business currently consists of internal teams of sales and marketing professionals, respectively, with deep experience in the company’s industry, as well as a network of primarily U.S. field-based sales representatives who are knowledgeable about the company’s tests and testing services. Historically, the company has significantly relied on organic growth and word-of-mouth among its customers to generate interest in its tests. In recent years, the company has invested significant time and capital to strengthen its sales and marketing efforts, including increasing the size and restructuring the organization of its internal team, re-focusing its initiatives and strategies, and increasing the overall scope of its marketing activities. On a regular basis, the company continues to evaluate the need to grow the size of its sales team and marketing resources.
Research and Development
For the Laboratory Services segment, the company’s research and development expenses were $28.4 million in 2024. For the Therapeutic Development segment, the company’s research and development expenses were $20.4 million in 2024.
Fulgent Pharma-Pre-Clinical Studies and Clinical Trials
FID-007 Phase 1/1b Clinical Trial
FID-007, nanoencapsulated paclitaxel, is being investigated in the United States to treat patients diagnosed with various cancers, including head and neck (H&N), ampullary, and pancreatic cancer. The company has released preliminary data and completed enrollment for a Phase 1/1b dose escalation/expansion clinical trial for the evaluation of FID-007 in treating patients diagnosed with advanced solid tumors. This Phase 1/1b trial is being conducted at clinical trial sites in the United States and has enrolled 50 patients. In this trial and as of December 31, 2024, the company observed FID-007 to have a manageable safety profile and observed preliminary evidence of anti-tumor activity in heavily pre-treated patients across various tumor types. The PK observed was linear, dose proportional, and comparable to that of nab paclitaxel. No neuropathy above grade two was observed.
FID-007 Phase 2 Clinical Trial
The company began enrollment of a Phase 2, randomized, multi-center, open-label trial of FID-007 in patients with recurrent or metastatic head and neck (H&N) squamous cell carcinoma at various sites in the United States in the second quarter of 2024. Up to 46 patients will be randomly enrolled assigned (1:1) to one of two treatment arms: Arm A: FID-007 (75 mg/m²) plus cetuximab, or Arm B: FID-007 (125 mg/m²) plus cetuximab. The company expects to complete the trial by early 2026. It anticipates releasing preliminary data for this trial in or around June 2025 and final results in or around June 2026. Assuming favorable results, the company plans to investigate FID-007 in a Phase 3 registrational clinical trial in patients diagnosed with H&N squamous cell carcinoma and potentially seek regulatory approval in the United States through the 505(b)(2) pathway, which may shorten the clinical trial process and accelerate potential commercialization.
FID-022 and ADC Pre-Clinical Development
The company is also continuing to engage in other clinical and preclinical development utilizing its nano-drug delivery platform. In its preclinical studies, the company observed its second drug candidate, FID-022, nanoencapsulated SN38, to have superior efficacy over irinotecan in various xenograft cancer models, including colon, bile duct, ovarian, and pancreatic cancers, with no significant unexpected toxicity observed in both rat and monkey Good Laboratory Practice or GLP toxicity studies. The company plans to next evaluate FID-022 in a Phase 1/1b clinical trial in patients diagnosed with these cancers. The IND for this trial was cleared by the FDA in January 2025. In connection with this trial, the company plans to enroll 42 patients at sites located in the United States and to begin dosing patients for this trial in mid-2025.
In addition, the company has made significant advancements in the development of antibody-drug conjugates or ADCs using its novel patented linker and payload platform technology. In preclinical studies, the company observed its ADC to have better efficacy over different tumors with a broad range of target antigen expression levels compared with some of the best ADC benchmarks on the market in preclinical studies. In the meantime, ADCs honing novel targets using the company’s platform technology are also being prepared with the goal of generating leading candidates for clinical studies.
Suppliers
In particular, the company relies on Illumina, Inc., or Illumina, as the sole supplier of the next generation sequencers and associated reagents it uses to perform its genetic tests and as the sole provider of maintenance and repair services for these sequencers; on Roche Holdings AG for certain laboratory equipment, supplies, and services for its immunohistochemistry services; on Beckman Coulter Diagnostics for certain laboratory equipment, supplies, and services for its flow cytometry tests and testing services; on Leica Biosystems for an automated digital scanning solution to scale up digital pathology operations; and on Abbott Laboratories for certain laboratory equipment, supplies, and services for its FISH tests and testing services. Additionally, the company’s therapeutic development business relies on ANP Technologies, Inc. for certain laboratory services, equipment, tools, and drug intermediates in connection with its research and development efforts.
The company also relies on in-licensing opportunities to develop, strengthen, and maintain its proprietary position in the fields targeted by its drug candidates, including FID-007 and FID-022. In June 2017, the company entered into an exclusive license agreement with ANP Technologies, Inc., or ANP, as amended on December 28, 2017, and May 1, 2024. Under the agreement, ANP granted the company ownership of certain patents and patent applications, and an exclusive, worldwide, perpetual, irrevocable, and sublicensable license to certain rights in patents and patent applications under which the company may develop and commercialize FID-007 and FID-022 and related formulations for human therapeutic, prophylactic, and diagnostic uses.
Competition
The company’s principal competitors include companies such as Laboratory Corporation of America Holdings; Natera, Inc.; Myriad Genetics, Inc.; and Quest Diagnostics Incorporated.
Trademarks
The company owns registered or unregistered trademark rights to Fulgent, Picture Genetics, BEACON, INFORMDX, LUMERA, and the company name and logo.
Intellectual Property
Worldwide, the company owned or exclusively in-licensed over 20 issued or allowed patents and over 10 active patent applications as of December 31, 2024. This includes eight issued or allowed U.S. patents. Patents in these patent families are expected to expire by 2034, and patent applications in these patent families, if granted, are expected to expire as far out as 2044, subject to any patent term disclaimers, adjustments, or extensions. Patents and/or patent applications in these families are active in multiple jurisdictions, including the United States, Australia, Canada, China, the European Patent Organization, Germany, New Zealand, Japan, and Switzerland. In addition to these owned and exclusively licensed patents and active patent applications, the company licenses patents on a non-exclusive and/or territory-restricted basis.
In particular, as of December 31, 2024, the company owned or exclusively in-licensed 18 issued patents and five patent applications relating to FID-007 and related formulations. The United States and foreign patents (Canada, China, Germany, France, the United Kingdom, Japan, Australia, and New Zealand) were granted in these families, and these patents are expected to expire by 2034, absent any patent term extension.
Governmental Regulation
The company’s laboratories located in California, Texas, Georgia, Massachusetts, and Arizona are CLIA-certified and are accredited by the College of American Pathologists, or CAP, and the Centers for Medicare & Medicaid Services, or CMS.
The company’s clinical laboratories are required to maintain certain state laboratory licenses. State laws establish standards for day-to-day operations of its laboratories, including requirements with respect to the training and skills required of personnel, quality control, and proficiency testing requirements.
The company’s advertising for laboratory services and tests is subject to federal truth-in-advertising laws enforced by the Federal Trade Commission, or FTC, as well as comparable state consumer protection agencies under similarly broad state laws.
The company bill insurance payors, both commercial and government, for the company’s tests and testing services using Current Procedural Terminology, or CPT, codes, which are published by the American Medical Association, or AMA.
PAMA
Under the Administrative Simplification provisions of the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, as amended by the federal Health Information Technology for Economic and Clinical Health Act, or HITECH, the U.S. Department of HHS has issued regulations, or HIPAA Regulations, that establish uniform standards governing the conduct of certain electronic healthcare transactions and requirements for protecting the privacy and security of protected health information, or PHI, used or disclosed by healthcare providers, health plans, and healthcare clearinghouses that conduct certain healthcare transactions electronically, known as “covered entities.” As a clinical laboratory, the company is acting as a covered entity and are subject to HIPAA and HITECH.
In addition to being directly responsible for compliance with applicable HITECH Act requirements and HIPAA regulations as a business associate, the company has contractually agreed to comply with HITECH and HIPAA Regulations; and in some instances, the company has agreed to indemnify the company’s covered entity clients if it breaches its obligations with respect to these laws and regulations and/or in the event of a reportable breach of PHI.
The California Privacy Rights Act and other state privacy laws could impact the company’s operations or that of its collaborators and business partners and impose new regulatory requirements and increase costs of compliance.
In the United States, the company must comply with various fraud and abuse laws, and the company is subject to regulation by various federal, state, and local authorities, including CMS, other divisions of HHS (such as the Office of Inspector General), the U.S. Department of Justice, individual U.S. Attorney’s Offices within the Department of Justice, and state and local governments.
The company is also subject to the U.S. federal law directed at ‘self-referrals,’ commonly known as the ‘Stark Law,’ which prohibits a physician from making referrals for certain designated health services, including laboratory services, that are covered by the Medicare program, to an entity with which the physician or an immediate family member has a direct or indirect financial relationship, unless an exception applies.
The company is subject to the U.S. Foreign Corrupt Practices Act, or FCPA, which prohibits companies and their intermediaries from making payments in violation of law to non-U.S. government officials for the purpose of obtaining or retaining business or securing any other improper advantage.
History
The company was founded in 2011. It was incorporated in May 2016. The company was formerly known as Fulgent Diagnostics, Inc. and changed its name to Fulgent Genetics, Inc. in August 2016.