Influenza B virus infection

The TGS program, a leading example of biosecurity infrastructure, operates at a total of nine US locations and leverages voluntary nasal swabs as well as wastewater sampling from international travelers to detect more than 30 pathogens. BOSTON, March 12, 2024 /PRNewswire/ -- Ginkgo Bioworks (NYSE: DNA), which is building the leading platform for cell programming and biosecurity, the Centers for Disease Control and Prevention (CDC), and XpresCheck, by XWELL, Inc. (Nasdaq: XWEL), a leader in the delivery of onsite pathogen screening, today announced they are expanding the CDC's Traveler-based Genomic Surveillance program (TGS) to new collection locations at US international airports in Miami (MIA) and Chicago (ORD). Continue Reading (PRNewsfoto/Ginkgo Bioworks) Additional program funding and expanded program scope, which will double the CDC's current investment in TGS, will be used to substantially increase the volume of nasal and wastewater samples collected, tested, and sequenced using a custom multipathogen panel. This expanded funding will also bring the number of airports in the program to a total of nine active sites: Los Angeles, San Francisco, New York (JFK), Washington Dulles, Newark, Boston, Seattle, Miami, and Chicago. Since its inception in September 2021, the TGS program has demonstrated its ability to serve as an early detection mechanism for new pathogens and fill gaps in global biosurveillance. The program has detected several novel strains of SARS-CoV-2 (the virus that causes COVID-19), using different sample types, including nasal swabs collected anonymously from volunteer international travelers arriving at participating airports hosting mobile testing centers in terminals, as well as wastewater samples from airplanes and airport triturators. In October 2023, the program expanded to cover a list of more than 30 viral and bacterial targets. The first phase of multipathogen testing and sequencing in November and December 2023 proved successful, and the TGS program was able to detect positive samples containing several pathogens of interest, including influenza A and B, RSV, and Mycoplasma pneumoniae, a bacteria that causes pneumonia. "We are thrilled to have the opportunity to take the TGS program to the next level. Multipathogen biomonitoring expands this critical biosecurity infrastructure for the United States," said Matt McKnight, General Manager for Biosecurity at Ginkgo Bioworks. "The frequency of new outbreaks around the world reminds us every day that persistent and strategically focused biosurveillance is paramount to ensure readiness and rapid response. We are honored that CDC continues to trust this consortium to deliver a strategic piece of our biothreat preparedness." The program continues to innovate in the space of pathogen genomics and biosecurity by introducing new collection modalities, launching in new locations, and refining the list of target pathogens to provide a clearer picture of what pathogens are circulating in the international travel system. It is supported by robust operational partnership. "This expansion demonstrates the continued capability of the TGS program and is a further realization of the goal set out by the CDC and the Federal Government to incorporate this program as part of a permanent biosecurity effort in the United States," said Ezra Ernst, CEO of XpresCheck. "It allows us to continue providing a frontline defense against potential pathogens entering our country and reinforces our commitment to public health." "The additional funding of the program allows us to add infrastructure to support new mobile testing centers at Miami International Airport and Chicago O'Hare International Airport. It will also enable us to increase testing capacity at existing airports, reinforcing our position as the largest consortium of partners in the biosecurity space," added Ernst. About XWELL, Inc. XWELL, Inc. (Nasdaq: XWEL) is a leading global wellness holding company operating multiple brands: XpresSpa®, Treat™, Naples Wax Center®, XpresCheck® and HyperPointe™. XpresSpa and its Treat brand are leading retailers of wellness services and related products, with 34 locations in 15 airports globally. Naples Wax Center is a group of upscale skin care boutiques, with three locations currently operating. XpresCheck is a provider of screening and diagnostic testing in partnership with the CDC and Concentric by Ginkgo, conducting bio-surveillance monitoring in its airport locations to identify new SARS-CoV-2 variants of interest and concern as well as other pathogens entering the country from across the world. HyperPointe is a leading digital healthcare and data analytics relationship company serving the global healthcare industry.  About Ginkgo Bioworks Ginkgo Bioworks is the leading horizontal platform for cell programming, providing flexible, end-to-end services that solve challenges for organizations across diverse markets, from food and agriculture to pharmaceuticals to industrial and specialty chemicals. Ginkgo's biosecurity and public health unit, Concentric by Ginkgo, is building global infrastructure for biosecurity to empower governments, communities, and public health leaders to prevent, detect and respond to a wide variety of biological threats. For more information, visit ginkgobioworks.com and concentricbyginkgo.com, read our blog, or follow us on social media channels such as X (formerly known as Twitter) (@Ginkgo and @ConcentricByGinkgo), Instagram (@GinkgoBioworks), Threads (@GinkgoBioworks), or LinkedIn. Forward-Looking Statements of XWELL, Inc. This press release may contain "forward-looking" statements within the meaning of Section 27A of the Securities Act of 1933, and Section 21E of the Securities Exchange Act of 1934. These include statements preceded by, followed by or that otherwise include the words "believes," "expects," "anticipates," "estimates," "projects," "intends," "should," "seeks," "future," "continue," or the negative of such terms, or other comparable terminology. Forward-looking statements relating to expectations about future results or events, including the Company's current plans and expectations relating to the business and operations and future store openings for Naples Wax Center, are based upon information available to XWELL as of today's date and are not guarantees of the future performance of the Company, and actual results may vary materially from the results and expectations discussed. Additional information concerning these and other risks is contained in the Company's Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K, and other Securities and Exchange Commission filings. All subsequent written and oral forward-looking statements concerning XWELL, or other matters and attributable to XWELL or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements above. XWELL does not undertake any obligation to publicly update any of these forward-looking statements to reflect events or circumstances that may arise after the date hereof. Forward-Looking Statements of Ginkgo Bioworks This press release contains certain forward-looking statements within the meaning of the federal securities laws, including statements regarding the capabilities and potential success of the partnership and Ginkgo's biosecurity platform. These forward-looking statements generally are identified by the words "believe," "can," "project," "potential," "expect," "anticipate," "estimate," "intend," "strategy," "future," "opportunity," "plan," "may," "should," "will," "would," "will be," "will continue," "will likely result," and similar expressions. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this press release, including but not limited to: (i) volatility in the price of Ginkgo's securities due to a variety of factors, including changes in the competitive and highly regulated industries in which Ginkgo operates and plans to operate, variations in performance across competitors, and changes in laws and regulations affecting Ginkgo's business, (ii) the ability to implement business plans, forecasts, and other expectations, and to identify and realize additional business opportunities, (iii) the risk of downturns in demand for products using synthetic biology, (iv) the uncertainty regarding the demand for passive monitoring programs and biosecurity services, (v) changes to the biosecurity industry, including due to advancements in technology, emerging competition and evolution in industry demands, standards and regulations, (vi) the outcome of any pending or potential legal proceedings against Ginkgo, (vii) our ability to realize the expected benefits from and the success of our Foundry platform programs, (viii) our ability to successfully develop engineered cells, bioprocesses, data packages or other deliverables, and (ix) the product development or commercialization success of our customers. The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties described in the "Risk Factors" section of Ginkgo's annual report on Form 10-K filed with the U.S. Securities and Exchange Commission (the "SEC") on February 29, 2024 and other documents filed by Ginkgo from time to time with the SEC. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and Ginkgo assumes no obligation and does not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. Ginkgo does not give any assurance that it will achieve its expectations. XWELL INVESTOR CONTACT: [email protected] XWELL MEDIA CONTACT: [email protected] GINKGO BIOWORKS INVESTOR CONTACT: [email protected] GINKGO BIOWORKS MEDIA CONTACT: [email protected] SOURCE Ginkgo Bioworks

The clinical laboratory real-time PCR multiplex test was designed using Co-Dx Co-Primers™ and licensed by the CDSCO for use in diagnostic procedures SALT LAKE CITY, March 7, 2024 /PRNewswire/ -- Co-Diagnostics, Inc. (Nasdaq: CODX) (the "Company" or "Co-Dx"), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, announced today that CoSara Diagnostics Pvt Ltd ("CoSara," or the "JV"), its joint venture for manufacturing and sales in India, has received clearance by the Central Drugs Standard Control Organization ("CDSCO") in India to manufacture and sell its SARAPLEX™ Influenza Multiplex (IFM) Test Kit to clinical laboratories as an in vitro diagnostic ("IVD") for the detection and differentiation of Influenza A and Influenza B. CoSara's new real-time multiplex PCR test is built on the Company's patented Co-Primers™ technology and designed to simultaneously detect influenza A (H1N1, H3N2, H7N9, H1N2, H5N1, H2N2, H9N2, H10N8, H5N6, H7N7, H7N4, H7N2 and H2N1), influenza B (Yamagata and Victoria strains) and to differentiate between H1N1 and H3N2. Co-Primers utilize a unique design architecture to combat common issues with real-time PCR that can lead to inaccurate results, specifically primer dimer propagation, and which are magnified in multiplex reactions. "The importance of accurate, reliable PCR testing at the high-throughput clinical laboratory level remains critical," remarked Dwight Egan, CEO of Co-Diagnostics. "We are pleased that our Co-Primers technology will help to combat respiratory illnesses in India as the world continues to adjust in the wake of the pandemic, and while we work with CoSara in preparation for playing an important role in the next stage of our Company's growth with the upcoming launch of our Co-Dx™ PCR Pro™ instrument*." CoSara Director Mohal Sarabhai commented, "This test marks the 15th of CoSara's clinical lab tests to receive IVD clearance by the CDSCO, and adds to our expanding menu of valuable diagnostic tools available to our growing distributor and laboratory customer base. It strengthens our foundation for future growth as CoSara also assists in the progress of point-of-care testing across India, and prepares to provide manufacturing, distribution, and regulatory support for the forthcoming Co-Dx PCR platform." CoSara has previously received CDSCO clearance for RT-PCR tests for Mycobacterium tuberculosis, malaria, hepatitis B, hepatitis B viral load, hepatitis C, hepatitis C viral load, HPV types 16 and 18 and HPV-HR, two COVID-19 assays, chikungunya, dengue, a dengue/chikungunya duplex test, and a Flu A/Flu B/COVID-19 ("ABC") multiplex test, all designed using the Company's patented Co-Primers technology and cleared to be manufactured and sold to clinical laboratories in the Indian market as IVDs. *The Co-Dx PCR platform (including the PCR Home™, PCR Pro™, mobile app, and all associated tests) is subject to review by the FDA and/or other regulatory bodies and is not yet available for sale. The Co-Dx PCR Pro instrument and Co-Dx COVID-19 Test are currently under review by the FDA. About Co-Diagnostics, Inc.: Co-Diagnostics, Inc., a Utah corporation, is a molecular diagnostics company that develops, manufactures and markets state-of-the-art diagnostics technologies. The Company's technologies are utilized for tests that are designed using the detection and/or analysis of nucleic acid molecules (DNA or RNA). The Company also uses its proprietary technology to design specific tests for its Co-Dx PCR at-home and point-of-care platform and to locate genetic markers for use in applications other than infectious disease. Forward-Looking Statements: This press release contains forward-looking statements. Forward-looking statements can be identified by words such as "believes," "expects," "estimates," "intends," "may," "plans," "will" and similar expressions, or the negative of these words. Such forward-looking statements are based on facts and conditions as they exist at the time such statements are made and predictions as to future facts and conditions. Forward-looking statements are subject to inherent uncertainties, risks and changes in circumstances. Actual results may differ materially from those contemplated or anticipated by such forward-looking statements. Readers of this press release are cautioned not to place undue reliance on any forward-looking statements. There can be no assurance that any of the anticipated results will occur on a timely basis or at all due to certain risks and uncertainties, a discussion of which can be found in our Risk Factors disclosure in our Annual Report on Form 10-K, filed with the Securities and Exchange Commission (SEC) on March 16, 2023, and in our other filings with the SEC. The Company does not undertake any obligation to update any forward-looking statement relating to matters discussed in this press release, except as may be required by applicable securities laws. SOURCE Co-Diagnostics

– Over 60 participants dosed in two additional cohorts; initial data expected in the second quarter – – Approximately 50% of participants have compensated cirrhosis – SAN FRANCISCO--(BUSINESS WIRE)-- VIR BIOTECHNOLOGY Inc. (Nasdaq: VIR) today announced that its Phase 2 SOLSTICE clinical trial evaluating the safety, tolerability and efficacy of tobevibart and elebsiran for the treatment of people living with chronic hepatitis delta (CHD) virus has completed enrollment of its current cohorts one month earlier than anticipated. This includes over 60 participants in two additional cohorts – one evaluating tobevibart given every 2 weeks and the other evaluating the combination of tobevibart and elebsiran given every 4 weeks. Initial data are expected in the second quarter of 2024. “The swift completion of enrollment ahead of expectations reflects the strong patient and physician interest being generated, and the urgent need for new treatment options for the millions of underserved hepatitis delta patients,” said Carey Hwang, M.D., Ph.D., Vir’s Senior Vice President, Clinical Research. “We are proud of the continued progress towards our goal of developing a safe and efficacious chronic therapy to address the significant treatment gap and look forward to reporting additional data on these participants this year.” Of the participants dosed, approximately 50% have compensated cirrhosis. In the second quarter, the Company expects to report additional 12-week treatment data on 30 participants (15 per regimen) and 24-week treatment data on 20 participants (10 per regimen). Additional 24-week treatment data for all participants is expected in the fourth quarter of 2024. SOLSTICE is a Phase 2 multi-center, open-label trial designed to evaluate the safety, tolerability, and efficacy of tobevibart and elebsiran in adult participants (age 18 to 69) with CHD infection receiving nucleot(s)ide reverse transcriptase inhibitor therapy. Depending on the cohort, trial participants are receiving multiple doses of tobevibart and elebsiran as either monotherapy or in combination administered via subcutaneous injection for up to 88 weeks. The primary endpoints of the trial are the proportion of study participants achieving either a ≥ 2log10 decrease in HDV RNA compared to baseline or HDV RNA less than the limit of detection and normalization of alanine transaminase (ALT) at Week 24. About Tobevibart Tobevibart is an investigational subcutaneously administered antibody designed to block entry of hepatitis B and hepatitis delta viruses into hepatocytes and to reduce the level of virions and subviral particles in the blood. Tobevibart, which incorporates Xencor’s Xtend™ and other Fc technologies, has been engineered to potentially function as a T cell vaccine against hepatitis B virus and hepatitis delta virus, as well as to have an extended half-life. Tobevibart was identified using Vir’s proprietary mAb discovery platform. About Elebsiran Elebsiran is an investigational subcutaneously administered hepatitis B virus-targeting small interfering ribonucleic acid (siRNA) that Vir believes has the potential to stimulate an immune response and have direct antiviral activity against hepatitis B virus and hepatitis delta virus. It is the first siRNA in the clinic to include Enhanced Stabilization Chemistry Plus (ESC+) technology to enhance stability and minimize off-target activity, which potentially could result in an increased therapeutic index. Elebsiran is the first asset in the Company’s collaboration with Alnylam Pharmaceuticals, Inc. to enter clinical trials. About Vir Biotechnology, Inc. Vir Biotechnology, Inc. is an immunology company focused on powering the immune system to transform lives by treating and preventing infectious diseases and other serious conditions, including viral-associated diseases. Vir has assembled two technology platforms that are designed to modulate the immune system by exploiting critical observations of natural immune processes. Its current clinical development pipeline consists of product candidates targeting hepatitis delta and hepatitis B viruses and human immunodeficiency virus. Vir has several preclinical candidates in its pipeline, including those targeting influenza A and B, COVID-19, RSV/MPV and HPV. Vir routinely posts information that may be important to investors on its website. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “plan,” “potential,” “aim,” “expect,” “anticipate,” “promising” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Vir’s expectations and assumptions as of the date of this press release. Forward-looking statements contained in this press release include, but are not limited to, statements regarding Vir’s strategy and plans; the potential benefits, safety and efficacy of tobevibart and elebsiran for the treatment of chronic hepatitis delta; the timing and design of the Phase 2 SOLSTICE clinical trial, including enrollment and the anticipated timing of data readouts or presentations; statements regarding Vir’s scientific and executional expertise; and risks and uncertainties associated with drug development and commercialization. Many factors may cause differences between current expectations and actual results, including risks of unexpected safety or efficacy data or results observed during the Phase 2 SOLSTICE trial or in data readouts; the occurrence of adverse safety events; risks of unexpected costs, delays or other unexpected hurdles; the timing and outcome of Vir’s planned interactions with regulatory authorities; difficulties in obtaining regulatory approval; challenges in accessing manufacturing capacity; clinical site activation rates or clinical trial enrollment rates that are lower than expected; difficulties in collaborating with other companies; successful development and/or commercialization of alternative product candidates by Vir’s competitors; changes in expected or existing competition; delays in or disruptions to Vir’s business or clinical trials due to geopolitical changes or other external factors; and unexpected litigation or other disputes. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later-stage or larger-scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements, or the scientific data presented. Other factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Vir’s filings with the U.S. Securities and Exchange Commission, including the section titled “Risk Factors” contained therein. Except as required by law, Vir assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.