At that time the testing schedule will be determined, and the Department(s) can work with Fulgent to track it appropriately. The requests will be reviewed by subject matter experts (SMEs) from your departmental human resources in collaboration with the Department of Human Resources and County Counsel. Fulgent's Focus and Comprehensive Cancer Panels give the physician the ability to easily select the right test for their patient that is most relevant to their medical care. Villanueva said Fulgent Genetics has "strong ties" to Chinese technology and genomics companies though he did not specify what those ties were, according to the Los Angeles Times. Form 10-Q. Form 10-K. Q3. When your results are ready, you will receive either an email or text message with a screening ID (in the format FSS-SCR123456) along with the link to view your test result. What safeguards are in place to prevent employees from submitting false records? South Gate West Covina West LA Please contact your Departmental Human Resources office for your required testing frequency. Results should be. This method is also called a nucleic acid amplification test (NAAT). U.S. officials have expressed concerns over state-sponsored harvesting of genetic data. The Blueshirt GroupNicole Borsje, 415-217-2633; nicole@blueshirtgroup.com, Fulgent Genetics Announces Acquisition of CSI Laboratories. Testing frequency will be based onyourclassification/role and will be informed byPublicHealth best practices and/or federal,stateand local orders. Fulgent Residence System 1.0 - Login Miami-Dade County has transitioned to using Fulgent Genetics' FDA EUA-approved RT-PCR test. All the testing sites utilize a shallow nasal swab test. Home addresses are required because if an employee receives a positive test, that must be reported to the state and local health departments for the purposes of contact tracing and virus and variant monitoring. Additional information about COVID-19 vaccine efficacy, safety, and the benefits of being vaccinated has been compiled by the CDC document Key Things to Know About COVID-19 Vaccines, available at https://www.cdc.gov/coronavirus/2019-ncov/vaccines/keythingstoknow.html. Employees who have not provided proof of full vaccination status should request reasonable time off from their supervisor to test for COVID-19 and discuss their testing schedule until fully vaccinated. Chinese government officials have used events hosted by the National Committee on U.S.-China Relations to criticize U.S. government policy regarding China, often without pushback from the committee. By providing health insurance information, County employees are helping to ensure that the County can appropriately bill its health care plans for testing conducted at County Employee Testing Sites, thereby allowing the County to reserve funds for critical public services. You may submit aRequest for Reconsideration Formalong with a copy ofyouroriginal Request forAccommodation. All specimens are processed at our US laboratory. For more information visit: http://covid19.lacounty.gov/testing. The proof of vaccination must include the date the vaccine was received. A qualifying medical exemption may be granted for contraindications to the vaccine, such as a severe allergic reaction to any ingredient in an mRNA COVID-19 vaccine, or for any other medically necessary restriction determined by a licensed healthcare provider. According to the policy, Fulgent can transmit medical information collected in the United States to other countries, including those with less stringent data protection laws. No laboratory test is 100% accurate. Uyghurs, Obama's Man in China Now Beijing's Man in Washington. Los Angeles County Sheriff Alex Villanueva said Monday that his department would no longer use the county's COVID-19 testing provider because of its alleged connections with China. Fulgent Genetics, Inc. (NASDAQ: FLGT) (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 that it has acquired CSI Laboratories (CSI) to expand its presence in somatic molecular diagnostics and cancer testing. 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. received one shot in a two-dose series)? However,youwill not be subject to any corrective action for non-compliance while the department is reviewingyouraccommodationrequest and/or engaging in the interactive process. However, in order to ensure you are in compliance with the Countys testing/ vaccination policies, they will see if you are cleared, or not cleared for work. Submission of a complete Request forAccommodationalone does not automatically excuseyoufrom requirements of this Policy. This website features an integrated map locator and offers the ability to filter testing sites by testing modality (walk-up vs. drive-up) and day of the week. Where can I find a listing of all the County-approved testing sites? Beginning October 1, 2022, mandatory weekly COVID-19 screening testing of unvaccinated County workers will no longer be required under the Countys Vaccination Policy until further notice. The company contracts with the U.S. Centers for Disease Control and Prevention (CDC) on COVID-19 sequencing and works with other large public agencies, such as the Houston-area public school system and Health Department to conduct routine COVID-19 testing and tracking. 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. Fulgent Genetics | 8,049 followers on LinkedIn. What happens if my Request for Reconsideration is denied by the Department of Human Resources? A cornerstone of the Companys 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 lab services. Personal or philosophical objections to a COVID-19 vaccine are not sufficient justification for granting anaccommodationunder this Policy. In the event of a positive result, samples may be held for up to 14-days for subsequent NGS analysis of the viral genome and then destroyed as outlined above. This test has only been authorized by the FDA for detection of nucleic acid from SARS-CoV-2 (i.e., the COVID-19 virus), and not for any other virus or pathogen. These risks and uncertainties include, among others: CSI may not produce the anticipated benefits discussed in this release; the integration of CSI may consume more management and other resources than anticipated; the somatic molecular diagnostics and oncology markets may not grow at the rates anticipated; the ongoing impacts of the COVID-19 pandemic, including the preventive public health measures that may continue to impact demand for its genetics tests and the pandemics effects on the global supply chain; the market potential for, and the rate and degree of market adoption of, the Companys tests, including its newly-developed tests for COVID-19 and genetic testing generally; the Companys 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 Companys ability to successfully integrate acquired businesses and assets into its business strategy and to derive value from its investments; the Companys ability to maintain the low internal costs of its business model, particularly as the Company makes investments across its business; the Companys 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 Companys sale prices for and margins on its tests; risks related to volatility in the Companys results, which can fluctuate significantly from period to period; risks associated with the composition of the Companys 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 Companys revenue; the Companys ability to grow and diversify its customer base and increase demand from existing and new customers; the Companys investments in its infrastructure, including its sales organization and operational capabilities, and the extent to which these investments impact the Companys business and performance and enable it to manage any growth it may experience in future periods; the Companys level of success in obtaining coverage and adequate reimbursement and collectability levels from third-party payors for its tests; the Companys level of success in establishing and obtaining the intended benefits from CSI, partnerships, joint ventures or other relationships; the Companys compliance with the various evolving and complex laws and regulations applicable to its business and its industry; risks associated with the Companys international operations; the Companys ability to protect its proprietary technology platform; and general industry, economic, political and market conditions. If I begin or complete the vaccination process and provide proof, will my department revoke the proposed discipline? Employees can watch the Town Hall recordings and participate in future education sessions on County time. The authoritarian regime is also building massive databases of genetic data from across the globe, which would give China an advantage in developing treatments for future pandemics. 1001 and Section 17(g) of the OSH Act, individual who knowingly supplying false statements or documentation may be subject to criminal penalties. The COVID-19 Vaccination Policy calls for all County workers to be fully vaccinated for COVID-19 and provide proof of vaccination status, effective October 1, 2021, regardless of any teleworking arrangements. full-time, part-time, recurrent, temporary, and as-needed County employees), as well as all interns and volunteers supporting County services and/or working from County facilities must provide the County with proof of vaccination status. In order to safely, securely and efficiently confirm vaccination status and track the results of routine COVID-19 tests, as required by State health officer orders and County policy, the County opted to engage a leader in the healthcare field for this endeavor. Nosebleeds during this collection process are very rare and often associated with dry weather condition or outdoor testing. , Additionally, under prohibitions of 18 U.S.C. The lawsuit, Pugley v. Fulgent Genetics, Inc., et al, has been filed in the U.S. District Court for the Central District of California on behalf of all those who purchased Fulgent securities . We are extremely excited to add CSI Laboratories expertise and team to the Fulgent family, said Ming Hsieh, Chairman and CEO of Fulgent. Both tests are self-administered and results will be made available within 1-2 days of submitting your sample. If an employee tests positive for COVID-19 antibodies, does that qualify for a medical exemption? This includes contraindications to the vaccines, perthe most up to date COVID-19 vaccine guidelines from the Centers for Disease Control and Prevention (CDC), including,but not limited to: See theCDCs Interim Clinical Considerations for Use of COVID-19 Vaccinesfor details. The County follows the Vaccine Record Guidelines & Standards issued by the California Department of Public Health. As a reminder, the process for the DHS workforce: If an employee was vaccinated by DHS, their vaccination verification is complete. What to know As you wait to receive your test kit, you should stay at home, avoid contact with others,. PLEASE NOTE: Orders may only be placed by physicians and medical institutions. The County is committed to safeguarding the integrity of all County systems and protecting the privacy rights of the County workforce. On test day, bring the following to your test site: Yes, employees are required to present their health insurance information to take a COVID-19 test at any of the County Employee Testing Sites; however, the information is required only once and is stored for all future tests at Fulgent testing locations throughout the County. The CDC awarded a $35.8 million contract to Fulgent in March to sequence coronavirus variants. The disciplinary action policy can be deployed ifyoucontinue not to comply. CSI was founded in 1997 to provide a more client- and patient-focused model of cancer diagnostic testing for pathologists, community hospitals, and their patients. Apologies. The company was formerly known as Fulgent Diagnostics, Inc. and changed its name to Fulgent Genetics, Inc. in August 2016. Fulgent Genetics is a technology-based genetic testing company focused on transforming patient care in oncology, infectious and rare diseases, and reproductive health. The option to retest if indeterminate is available. TEMPLE CITY, Calif., Sept. 09, 2020 (GLOBE NEWSWIRE) -- Fulgent Genetics, Inc. (NASDAQ: FLGT) ("Fulgent Genetics" or the "company"), a technology company providing comprehensive testing. "The individual's DNA is not sequenced as part of Fulgent Genetics' COVID-19 testing. Explore the best option for your patient needs. Published under: More information can be found at myvaccinerecord.cdph.ca.gov/faq. The County will not see the demographic information on a personal level and no penalties will occur for declining to provide demographic information on any question. They referred to it as part of a "vaccine passport" system that all public employees must take part in or risk . This requirement can be found in: Information about how County employees can comply with this Policy, tools for uploading vaccination status, and clarification on requests for exemption for medical or religious reasons, is provided in the sections below. If you cannot get a test through a doctor, make an appointment for a COVID-19 test. The site requires individuals to provide their name, date of birth and the cell phone or email associated with their vaccine record in order to submit a request. Fulgent is required by State law (Title 17 of the California Code of Regulations Sections 2500-2505) and the LA County Department of Public Health to collect demographic information to help public health experts identify any potential disparity in COVID-19 testing and vaccine access among different populations. Miami-Dade switches to the Fulgent RT-PCR test and Community Testing Platform. If you do not submit your exemption/accommodation request(s) in a timely manner, you will receive a Notice of Noncompliance, which will result in disciplinary action if you do not come into compliance (e.g. Q2. Coronavirus Disease (COVID-19) Virus Testing. The system provides an option for employees to indicate if they are only partially vaccinated during the registration process. How do I know that my personal information is secure in this system? Can I register in Fulgent if I am only partially vaccinated (i.e. Both town halls were recorded and made available on the Countys Learning Net and at https://employee.hr.lacounty.gov/vaccinationsmandate. "Fulgent is an American company, and its founder, board of directors and leadership team is made up of United States citizens," Fulgent Genetics Chief Commercial Officer Brandon Perthuis said. While waiting for a response to a Request forAccommodation, youwill be subject to workplace safety requirements, such as masking, physical distancing, and regular COVID-19 testingin order tocomply with the policy in the interim. Youwill have a total of eight (8) weeks from the denial date to submit proofyouare fully vaccinated. Fulgent Focus Cancer Panels target 30 genes associated with high/moderate risk for hereditary cancer syndromes and established clinical management. State and Federal mandates ensure that the employee will not be required to pay a co-pay or cover any co-insurance costs. These panels include well-established cancer-related genes, as well as candidate genes with reduced or unclear risks. Employees who are not currently vaccinated or only partially vaccinated, will have the opportunity to indicate that in the Fulgent system. Fulgent must treat all County Information as Confidential and must encrypt County Information in accordance with CISO instruction in order to render County Information unusable, unreadable or indecipherable to unauthorized individuals. Los Angeles County sheriff Alex Villanueva said the FBI warned him and other county officials that Fulgent likely shares the health data it collects with the Chinese government. There is DNA in the sample, however Fulgents testing process only identifies COVID-19 viral markers and generic human markers (not individual DNA information) in order to confirm that the sample is of sufficient quality for COVID-19 testing. We expect the addition of CSI will deliver customers a superior experience relative to competitors who offer one-dimensional NGS testing or broader menus without NGS expertise., This is an exciting day for CSI Laboratories team members, clients and patients, and we are excited to join forces with a company that shares our same level of commitment to the cancer community, said Ron Ghafary, founder of CSI Laboratories. Will there be a penalty to the employee if there is a delay with submitting the requested forms? Collect using standard procedure for selected sample type/kit. Combining next generation sequencing (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. Fulgent Genetics, Inc., et al, has been filed in the U.S. District Court for the Central District of California on behalf of all those who purchased Fulgent securities between March 22, 2019, and . Employees must follow their departments time-off request process for the time off. To view our COVID-19 Privacy FAQs, click here. Fulgent, a company that provides Los Angeles County with coronavirus testing, plans to sue Sheriff Alex Villanueva for defamation. It turns out, that company has. CSI is a CLIA-certified and CAP-accredited cancer reference laboratory located in Alpharetta, GA. To obtain an exemption from the vaccination requirements, youmust submit a Request forExemption/ Accommodationform, as described at https://employee.hr.lacounty.gov/vaccine-mandate-exemption. The physical cards cannot be verified to the same extent as a smart QR code. Unvaccinated County employees are at greater risk of contracting and spreading COVID-19 within the workplace, at County facilities, and to the public that depends on County services. One accommodation may suffice, but it depends on the employees job duties at each department. This form will document and communicate final determination on your request forreligiousrelatedaccommodationto the vaccination requirement, and outline safety protocols to remain compliant. To upload your vaccination certification documentation to the Fulgent database. Unique genetic markers of the virus can be found in RNA that only remains in the body while the virus invades and replicates itself. Where can I go for more questions about vaccination requirements? Fulgent said the partnership would help the company "solidify our foothold in one of the fastest growing genetic testing markets in the world.". You can visit https://publichealth.lacounty.gov/Coronavirus/vaccine for the most up to date information about vaccine safety, availability and related resources. Employee may request anaccommodationdue to the following reasons: You must submit theRequest for MedicalAccommodationFormto your Departmental HR Manager (DHRM) or their designeeas soon as possible to remain in compliance with the COVID-19 Vaccination Policy. Lew hosted an event in February for Politburo member Yang Jiechi, who called on the United States to "stop meddling" in China's affairs by criticizing the regime for its human rights abuses in Tibet, Xinjiang, and Hong Kong. How does Fulgent use employees health insurance information? Review of these requests will follow the Countys current Reasonable Accommodation/Interactive Progress. YES. The testing sites exclusive to County employees also offer saliva specimen collection. The stock currently trades just above thirty three bucks a . What if I do not wish to receive the COVID-19 vaccination because of personal belief or a personal objection? All demographic information provided during registration is shared with the California and Los Angeles County Department of Public Health for disease control and public safety purposes (see response to Why am I being asked to share demographic information?). The effectiveness of the protections afforded by OSHAs Vaccination and Testing ETS relies on employees providing truthful and accurate information, including, where applicable, proof of vaccination status and COVID-19 test results, to their employers, and on their employers maintaining accurate records of vaccination status and testing results. The firm claims the sheriff falsely stated that FBI officials . Fulgent will leverage its established technology platform, NGS expertise, lab operations, and sales infrastructure in conjunction with CSIs extensive cancer testing menu to establish a differentiated foothold in oncologic testing in the United States. Surveillance Employees may also access a listing at https://employee.covid19.lacounty.gov. , You are permitted to submit a request for exemption/accommodation at any time, however failure to do so in a timely manner may result in being marked as noncompliant. Where can I get information about COVID-19 vaccine safety and benefits? Our vision is to combine Fulgents excellence in NGS with the broad, high-quality oncologic testing menu already existing in CSI and bring it to a national client base. What can I do if I lost my vaccination card? Why am I asked to provide my health insurance information? Label each specimen with at least two unique identifiers that match the order paperwork (e.g. Founded in 2011, Fulgent has expanded its business in China in recent years while forming ties to a politically connected American think tank considered soft on China, the National Committee on U.S.-China Relations. To learn about our at-home testing option, visit www.PictureGenetics.com/covid19. The estimate is for $110 million for 2021 and $32 million in the third quarter alone. Please visit the employee COVID-19 Vaccination Policy informational site (https://employee.hr.lacounty.gov/vaccinationsmandate) to find more information about using the Fulgent system, a helpful user-guide and a step-by-step video tutorial on how to register and upload your proof of vaccination. This diagnostic firm offers various Covid-19, molecular diagnostic, and genetic tests. NOTE: As of October 1, 2022, the weekly testing requirement for unvaccinated employees has been suspended. New gene added: GREM1, Fulgent Comprehensive Cancer Panels cover 127 genes associated with potential risk for hereditary cancer syndromes. The application is NOT supported by Internet Explorer. Can I voluntarily remain unvaccinated as long as I agree to submit to regular testing? The CDC awarded a $35.8 million contract to Fulgent in March to sequence coronavirus variants. 25). Registering online ahead of time is preferred though, as it will help to speed up the testing process. The agency told Los Angeles County officials last week it had obtained "very concerning information" about Fulgent Genetics, a California-based firm founded by Chinese-American billionaire Ming Hsieh. Alzheimer and Dementia NGS Panel In addition, the county will use the. Will I be required to test if I am unvaccinated? Registration only has to be done one time and once complete, you will receive a QR code which can be used to verify your information for all future tests. Republican lawmakers expressed outrage that the federal government has awarded contracts to Fulgent. China CSI was founded in 1997 to provide a client- and patient-focused model of cancer diagnostic testing for pathologists, community hospitals, and their patients. COVID-19 vaccine exemptions may be granted for medical reasons. Please use one of the following Browsers: Microsoft Edge. Once the request has been processed in the system, you will receive a link delivered to the email or mobile phone number associated with the vaccination record containing their COVID-19 vaccination information (including name, date of birth, vaccination date(s), and vaccine manufacturer) and scannable QR code confirming the vaccine record is authentic. Employees who submit their physical card will have their card reviewed manually for authenticity using all available criteria. The law has stoked international concern that Chinese authorities will misuse the data for espionage or surveillance. Partially vaccinated employees can return to provide additional information when they obtain their final shot. The FBI did not respond to a request for comment. Is health insurance information required to test? If I file a request for an exemption/accommodation, what is the process used to review the merits of that request? A sincerely held religious belief, practice, or observance that conflicts with receiving a COVID-19 vaccine. The full cost of the test will be covered by the employees insurance (for additional information, please see response to Why am I asked to provide my health insurance information?). Molecular testing is capable of detecting active COVID-19 infections in the human body. As stated in Attachment II (page 2) of the vaccination policy entitled COVID-19 Vaccination Policy Corrective Action Plan, an employee who fails to comply with their departments Notice of Vaccination Requirement or timelines set after a denial of an exemption request or request for reconsideration, will receive a five (5) day suspension. Eligible employees who are designated as mileage permittees or occasional drivers/permittees (as designated by their department) are eligible for mileage reimbursement, if appropriate. Clarification of the request may be sought from the employee where needed. Prior to testing please register online at lac.fulgentgenetics.com. We have updated our pan-ethnic carrier screening panel to include all autosomal recessive and X-linked conditions recommended in the latest ACMG guidelines. A negative test does not completely rule out an infection. He did not say whether the FBI suspects Fulgent of proactively providing the data to China, or whether the company turns it over to comply with Chinese law. Fulgent COVID-19 Test Results Lookup Billing Forms Book a COVID-19 Test Check COVID Test Results Check my Test Status Where did you take your test? Examples of forward-looking statements in this press release include statements about, among other things: managements and others beliefs, judgments and estimates regarding CSIs business, prospects, technology platform, products and services, including their value to Fulgent, their potential benefit to Fulgents business, platform, services, products and product candidates; Fulgents testing solutions and services, including its laboratory capacity and related matters; the Companys identification and evaluation of opportunities, estimates of market size and its ability to capitalize on opportunities to grow its business. One of the benefits of molecular testing is its sensitivity in detecting active infection, allowing patients to receive appropriate treatment and take measures to prevent spreading the disease. Increase the effectiveness of medications while reducing the risk of adverse drug reactions with PGx testing, available clinically through Fulgent, or at-home through Picture Genetics. Fulgent Genetics continues to build upon its genomic testing platform both organically and inorganically through multiple vectors, including expanding its test menu through R&D, partnerships,. If your request is approved, your designated department personnel will send to you theApproval ofAccommodationForm. Requests for Accommodation are considered confidential documents and will be filed separately from the employees personnel file. Naat ) system provides an option for employees to indicate if they only. Also called a nucleic acid amplification test ( NAAT ) follows the vaccine was received genetic tests to all. 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