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Fulgent Genetics, Inc. (NASDAQ: FLGT) is a technology-driven company specializing in genetic testing, with the mission of making advanced genetic diagnostics accessible and affordable. Founded in 2011, Fulgent Genetics focuses on providing flexible and comprehensive genetic testing solutions aimed at improving everyday lives. The company operates through two primary segments: laboratory services and therapeutic development.
The laboratory services segment, which is the main revenue generator, includes technical laboratory services and professional interpretation of laboratory results by licensed physicians. Fulgent Genetics offers a broad array of tests that cover various genetic disorders, helping clinicians and patients obtain clinically actionable diagnostic information.
The therapeutic development segment is dedicated to creating drug candidates for a broad range of cancers. Utilizing innovative nanoencapsulation and targeted therapy platforms, Fulgent aims to improve the pharmacokinetic profile and therapeutic window of new and existing cancer drugs.
One of the company's recent achievements is a partnership with CooperSurgical, enabling the addition of exclusive newborn genetic screening panels to the services offered by Cord Blood Registry® (CBR®), the largest private newborn stem cell preservation company globally.
Fulgent's Picture® Genetics, launched in 2019, provides consumers direct access to comprehensive genetic testing at home. The tests cater to various needs and offer clinically actionable, medical-grade results with professional oversight. This complements Fulgent's laboratory services by making genetic testing more accessible and user-friendly.
With its headquarters in El Monte, California, Fulgent Genetics continues to expand its reach, serving clients both in the United States and internationally. The company's commitment to excellence is reflected in its collaborations with top clinicians and continuous improvements to its testing panels and report formats.
On November 8, 2021, Helio Health and Fulgent Genetics announced at AASLD new data on HelioLiver, a blood test for early detection of hepatocellular carcinoma (HCC). HelioLiver demonstrated 91% specificity, with 76% sensitivity for early-stage HCC and 85% overall. This performance surpasses alpha-fetoprotein (AFP) and the GALAD model. The test, using cfDNA methylation and protein markers, can potentially revolutionize early liver cancer detection, improving patient outcomes by enabling timely treatment interventions.
Helio Health and Fulgent Genetics announced a late-breaking poster presentation on HelioLiver, a blood test for detecting hepatocellular carcinoma (HCC), at The Liver Meeting® 2021, scheduled for November 12-15, 2021. The test uses cell-free DNA methylation patterns and protein markers to improve early cancer detection. The presentation will feature David J. Taggart, PhD, and aims to highlight significant advancements in liver cancer screening. Helio Health focuses on AI-driven cancer detection, while Fulgent Genetics specializes in genetic testing innovations.
Fulgent Genetics (NASDAQ: FLGT) has launched a new antibody test for COVID-19 that targets neutralizing antibodies. This consumer-initiated test can be performed via a finger prick at home without needing a physician visit. The test aims to empower individuals with data on their immunity levels, helping to assess vaccine effectiveness and herd immunity. Fulgent has conducted over 12 million COVID-19 tests since the pandemic began, and this new offering enhances its existing testing capabilities.
Fulgent Genetics (NASDAQ: FLGT) will release its third quarter 2021 financial results on November 9, 2021, after market close. The company specializes in genetic testing for oncology, infectious diseases, and reproductive health. A conference call hosted by key executives will take place at 4:30 PM ET to discuss results and answer questions. Investors can access the call via audio webcast or by dialing in. Fulgent Genetics combines NGS technology with an extensive test menu, providing a comprehensive suite of services tailored to client needs.
Fulgent Genetics (NASDAQ: FLGT) announced a partnership with the Houston Health Department and local public schools to conduct COVID-19 testing for students this school year. Aiming to combat rising COVID-19 cases among school-age children, the initiative will utilize RT-PCR testing with parental consent. Participating districts include Houston ISD and Aldine ISD, with daily sample deliveries to Fulgent's Houston lab, ensuring results are available the next school day. The company's certified lab capabilities position it as a trusted provider for COVID-19 testing services.
Fulgent Genetics (FLGT) reported remarkable financial results for Q2 2021, with revenue soaring to $153.6 million, a 790% year-over-year increase. The company delivered around 1.6 million billable tests, significantly up from the previous year. Gross margin improved by 21 percentage points, and GAAP income reached $79.8 million, or $2.59 per share. Fulgent also made strategic investments including acquiring CSI Laboratories and boosting its position in FF Gene Biotech. For Q3 2021, it expects revenue between $125 million and $150 million, anticipating growth amid changing testing demands.
Fulgent Genetics has acquired CSI Laboratories to enhance its capabilities in somatic molecular diagnostics and cancer testing. CSI, known for its vast array of oncology tests, will complement Fulgent's expertise in next-generation sequencing (NGS). This acquisition aims to expand Fulgent’s market presence, with the somatic genetic testing market projected to reach $16.8 billion by 2030. Fulgent plans to leverage its technology platform and lab infrastructure to create a comprehensive cancer testing solution across the U.S., with a new lab in California enhancing operational capacity.
Fulgent Genetics (NASDAQ: FLGT) has partnered with Helio Health to commercialize blood-based early cancer detection tests. This partnership grants Fulgent exclusive rights for laboratory developed tests (LDTs) in the U.S. and Canada and includes a strategic investment in Helio. The focus will initially be on HelioLiver, a test for detecting liver cancer, which is currently in clinical trials. The companies aim to leverage their strengths in operations, marketing, and research to enhance early cancer detection capabilities and expand into additional tests for other cancers.
Fulgent Genetics (NASDAQ: FLGT) announced it will release its Q2 2021 financial results on August 5, 2021, after market close. Following this, a conference call will be hosted by CEO Ming Hsieh and other executives at 4:30 PM ET to discuss the results and answer questions. The company’s innovative technology platform offers extensive testing solutions, including full-gene sequencing and tailored options, ensuring high accuracy and competitive turnaround times, aimed to address diverse customer needs.
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