News Release

New oncology laboratory will focus on pathology and molecular services, particularly next generation sequencing

TEMPLE CITY, Calif.--(BUSINESS WIRE)--May 3, 2022-- Fulgent Genetics, Inc. (NASDAQ: FLGT) (“Fulgent Genetics”, “Fulgent”, or the “Company”), a technology-based genetic testing company focused on transforming patient care in oncology, infectious and rare diseases, and reproductive health, today announced the opening of its new state-of-the-art oncology laboratory in El Monte, California, near the Company’s global headquarters in Temple City. This new CLIA-certified lab will enable Fulgent to expand its capabilities in somatic molecular diagnostics and cancer testing and more efficiently serve oncology clients on the West Coast of the United States.

Fulgent’s new 25,000 square foot state-of-the art facility will supplement its next-generation sequencing (“NGS”) capabilities with testing across immunohistochemistry, flow cytometry, cytogenetic analysis, fluorescence in-situ hybridization (“FISH”) and molecular genetics, and will complement the Company’s existing pathology lab operations in Alpharetta, Georgia. Fulgent has made significant cash investments in the build-out of the new facility in El Monte and plans to make ongoing investments in sales and support infrastructure to further scale the operations of the lab on the West Coast. Fulgent’s Chief Medical Officer, Dr. Larry Weiss, has led the integration and expansion of the Company’s oncologic testing efforts since the acquisition of CSI Laboratories in August of 2021 and will continue to oversee operations of the new facility.

“We are excited to expand our strategy in cancer testing and molecular diagnostics with the opening of our new state-of-the-art facility in southern California,” said Dr. Larry Weiss, Chief Medical Officer of Fulgent Genetics. “While our CSI laboratory in Alpharetta has been on the forefront of diagnostic cancer testing, the new laboratory in El Monte is more concentrated in predictive cancer testing which is of special interest to hematologists, oncologists and biopharma in this era of precision medicine. To that point, the majority of the new facility’s wet space consists of NGS technology, and we will be offering a full suite of somatic and germline testing for cancer patients for both our East and West coast clients.”

“Oncology testing and precision medicine are core to our long-term growth strategy,” said Brandon Perthuis, Chief Commercial Officer of Fulgent Genetics. “We have long realized that Fulgent has a differentiated technology platform that enables us to deliver these types of services at scale, and with this new lab and expanded sales team, we believe we offer an attractive package of services, support and rapid turnaround time for oncology testing. While the CSI team has historically been focused on hospital-based pathology sales, this new lab and team will focus more on direct sales to hematologists and oncologists, significantly expanding our addressable market. The opening of this new lab is another major step for Fulgent in becoming a one-stop shop for oncology testing.”

About Fulgent Genetics

Fulgent Genetics is a technology-based genetic testing company focused on transforming patient care in oncology, infectious and rare diseases, and reproductive health. Fulgent Genetics’ proprietary technology platform has created a broad, flexible test menu and the ability to continually expand and improve its proprietary genetic reference library while maintaining accessible pricing, high accuracy, and competitive turnaround times. Combining next generation sequencing, or NGS, with its technology platform, the Company performs full-gene sequencing with deletion/duplication analysis in an array of panels that can be tailored to meet specific customer needs. A cornerstone of the Company’s business is its ability to provide expansive options and flexibility for all clients’ unique testing needs through a comprehensive technology offering including cloud computing, pipeline services, record management, web portal services, clinical workflow, sequencing as a service and automated laboratory services.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Examples of forward-looking statements in this press release include statements about, among other things: guidance regarding expected first quarter and annual financial results, including revenues, core revenues, GAAP income, and non-GAAP income; evaluations and judgments regarding market position, balance sheet, runway, momentum, reinvestments, acquisition strategies, and the performance of acquired businesses (including CSI Laboratories and FF Gene Biotech), investments and partnerships (including Helio Health and Spatial Genomics), relationships and the Company’s testing services and technology; future growth and the Company’s testing services and technologies; the Company’s identification and evaluation of opportunities and its ability to capitalize on opportunities, capture market share, or to expand its presence in certain markets; and the Company’s ability to continue to grow its business.

Forward-looking statements are statements other than historical facts and relate to future events or circumstances or the Company’s future performance, and they are based on management’s current assumptions, expectations, and beliefs concerning future developments and their potential effect on the Company’s business. These forward-looking statements are subject to a number of risks and uncertainties, which may cause the forward-looking events and circumstances described in this press release to not occur, and actual results to differ materially and adversely from those described in or implied by the forward-looking statements. These risks and uncertainties include, among others: the ongoing impacts of the COVID-19 pandemic, including the preventive public health measures that may continue to impact demand for its tests and the pandemic’s effects on the global supply chain; the market potential for, and the rate and degree of market adoption of, the Company’s tests, including its newly-developed tests for COVID-19 and genetic testing generally; the Company’s ability to capture a sizable share of the developing market for genetic and COVID-19 testing and to compete successfully in these markets, including its ability to continue to develop new tests that are attractive to its various customer markets, its ability to maintain turnaround times and otherwise keep pace with rapidly changing technology; the Company’s ability to maintain the low internal costs of its business model, particularly as the Company makes investments across its business; the Company’s ability to maintain an acceptable margin on sales of its tests, particularly in light of increasing competitive pressures and other factors that may continue to reduce the Company’s sale prices for and margins on its tests; risks related to volatility in the Company’s results, which can fluctuate significantly from period to period; risks associated with the composition of the Company’s customer base, which can fluctuate from period to period and can be comprised of a small number of customers that account for a significant portion of the Company’s revenue; the Company’s ability to grow and diversify its customer base and increase demand from existing and new customers; the Company’s investments in its infrastructure, including its sales organization and operational capabilities, and the extent to which these investments impact the Company’s business and performance and enable it to manage any growth it may experience in future periods; the Company’s level of success in obtaining coverage and adequate reimbursement and collectability levels from third-party payors for its tests; the Company’s level of success in establishing and obtaining the intended benefits from partnerships, strategic investments, joint ventures, acquisitions, or other relationships; the Company’s compliance with the various evolving and complex laws and regulations applicable to its business and its industry; risks associated with the Company’s international operations; the Company’s ability to protect its proprietary technology platform; and general industry, economic, political and market conditions. As a result of these risks and uncertainties, forward-looking statements should not be relied on or viewed as predictions of future events.

The forward-looking statements made in this press release speak only as of the date of this press release, and the Company assumes no obligation to update publicly any such forward-looking statements to reflect actual results or to changes in expectations, except as otherwise required by law.

The Company’s reports filed with the U.S. Securities and Exchange Commission, or the SEC, including its annual report on Form 10-K for the year ended December 31, 2020 filed with the SEC on March 8, 2021 and the other reports it files from time to time, including subsequently filed annual, quarterly and current reports, are made available on the Company’s website upon their filing with the SEC. These reports contain more information about the Company, its business and the risks affecting its business, as well as its results of operations for the periods covered by the financial results included in this press release.

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Source: Fulgent Genetics, Inc.