Latest news with #CLIA
Yahoo
6 days ago
- Business
- Yahoo
Illumina Stock May Benefit From New Agreement to Acquire SomaLogic
Illumina, Inc. ILMN recently entered into a definitive agreement with Standard BioTools LAB to acquire SomaLogic, a leader in data-driven proteomics technology, and other specified assets. The transaction is valued at $350 million in cash payable at closing, subject to customary adjustments, with additional payments of up to $75 million in near-term performance-based milestones and performance-based royalties. The acquisition is set to enhance Illumina's presence in the expanding proteomics market and advance the highly ambitious multiomics strategy announced last year. The company plans to close the deal in the first half of 2026. Since the June 23 announcement, ILMN shares jumped 2.9% to close at $93.23 yesterday. Illumina Protein Prep is already being used by nearly 40 early-access customers globally and will become broadly available starting in the third quarter of 2025. Combining SomaLogic's proteomics technology with its scalable NGS ecosystem, DRAGEN software and Illumina Connected Multiomics will speed up the technology development roadmap for proteomics and reduce the time and cost of proteomic research. Accordingly, the market sentiment surrounding ILMN stock is expected to remain positive, driven by this news. Illumina presently has a market capitalization of $14.49 billion. The company's earnings yield of 4.6% sits comfortably against the industry's -27.7% yield. It delivered an earnings beat of 56.4%, on average, in the trailing four quarters. The latest transaction builds on a co-development agreement formed in December 2021, where Illumina and SomaLogic agreed to bring in the SomaScan Proteomics Assay on ILMN's high-throughput next-generation sequencing (NGS) platforms. Over the past year, scientific evidence presented has highlighted the strength of SomaLogic's proteomics offerings in the areas of plexity, scalability and technical reproducibility. Researchers can also generate significant and impactful insights with high sensitivity, high throughput and thousands of protein markers in a single experiment. Image Source: Zacks Investment Research SomaLogic has approximately 250 employees worldwide working in commercial, research and development (R&D), lab operations, manufacturing and other roles. The company's Boulder, CO, facilities — including a CLIA- and CAP-certified lab, office and manufacturing space — will be included in the purchase. Further, Illumina will add SomaLogic's aptamer-based affinity proteomics platform to its portfolio. The kitted NGS-based panel business will add a high-margin consumable revenue stream. Assuming the deal closes as planned, Illumina expects this business to become profitable in 2027 on a non-GAAP operating income basis and for non-GAAP operating margins to align with Illumina in 2028. According to a Research report, the global proteomics market is estimated to be worth $41.65 billion in 2025 and expand at a compound annual growth rate (CAGR) of 14.9% by 2034. The growth of the market is likely to be fueled by ongoing R&D in the field and the use of high-quality tools for research purposes. Further, the growing need for personalized medicines, and constant collaborations and partnerships are also likely to drive the market expansion. In May, the company unveiled a new AI algorithm that accurately deciphers pathogenic regulatory genetic variants in the noncoding regions of the human genome. Built on state-of-the-art deep learning neural networks, PromoterAI turns data into insights, helping researchers accelerate new breakthroughs in the diagnosis of rare diseases. In the past month, ILMN shares have risen 14% compared with the industry's 2.5% growth. Illumina currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the broader medical space are Phibro Animal Health PAHC and Hims & Hers Health HIMS. While Phibro Animal Health sports a Zacks Rank #1 (Strong Buy) at present, Hims & Hers Health carries a Zacks Rank #2 (Buy) at present. You can see the complete list of today's Zacks #1 Rank stocks here. Estimates for Phibro Animal Health's fiscal 2025 earnings per share have jumped 5.2% to $2.04 in the past 30 days. Shares of the company have rallied 43.8% in the past year compared with the industry's 12.1% growth. Its earnings yield of 8.2% compares comfortably with the industry's 0.9% yield. PAHC's earnings surpassed estimates in each of the trailing four quarters, the average surprise being 30.6%. Hims & Hers Health shares have surged 108.8% in the past year. Estimates for the company's 2025 earnings per share have jumped 17.7% to 73 cents in the past 30 days. HIMS' earnings beat estimates twice in the trailing four quarters, matched in one and missed on another occasion, the average surprise being 19.6%. In the last reported quarter, it posted an earnings surprise of 66.7%. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Illumina, Inc. (ILMN) : Free Stock Analysis Report Phibro Animal Health Corporation (PAHC) : Free Stock Analysis Report Hims & Hers Health, Inc. (HIMS) : Free Stock Analysis Report Standard BioTools Inc. (LAB) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Associated Press
24-06-2025
- Business
- Associated Press
Axim Biotechnologies Files Pre-Submission With FDA for CLIA Waiver Pathway on Lactoferrin Point-of-Care Diagnostic Test
SAN DIEGO, CA - June 24, 2025 ( NEWMEDIAWIRE ) - Axim Biotechnologies, Inc. (OTCQB: AXIM), a leading developer of rapid diagnostic testing for ocular and systemic conditions, today announced that it has filed a Pre-Submission (Pre-Sub Q) with the U.S. Food and Drug Administration (FDA) as the first formal step in seeking a Clinical Laboratory Improvement Amendments (CLIA) Waiver for its rapid, point-of-care Lactoferrin diagnostic test (TearScan Lf). Axim's TearScan Lf is the first and only FDA 510 (k)-cleared point-of-care (POC) diagnostic test specifically intended to support the diagnosis of Aqueous Deficient Dry Eye Disease (ADDE). Lactoferrin tear levels are a convenient POC diagnostic that aids in determining the viability of the lacrimal gland. Lactoferrin levels are reduced in 80% of patients with ADDE. By distinguishing ADDE from other forms of Dry Eye Disease, the test helps avoid trial-and-error use of therapies that are ineffective for tear deficiency. Additionally, because Lactoferrin levels reflect lacrimal gland function, repeated testing allows the physician to monitor response to treatment and disease progression over time. The Pre-Sub Q process allows device developers to engage early with the FDA to receive feedback, clarify regulatory expectations, and minimize risks of delays during the formal waiver application. FDA feedback is anticipated within 60 days. Upon FDA feedback, the company plans to conduct a comparative clinical study to support its CLIA Waiver Application, which is expected to be submitted later this year. The FDA typically completes review of CLIA Waiver Applications within 90 days. Currently, facilities must obtain CLIA certification and adhere to laboratory protocols in order to administer Axim's Lactoferrin test. A CLIA waiver would eliminate the certification requirement and enable administration of the point-of-care Lactoferrin test by ophthalmologists and optometrists in non-laboratory settings thereby allowing for far broader clinical use and accelerating commercial adoption. 'The Company's Pre-Sub Q submission marks a significant milestone in its strategy to broaden access to its tests by obtaining a CLIA waiver. We are committed to making it easier for eye care providers to integrate our tests into their practices without complex lab infrastructure,' said Catalina Valencia, CEO of Axim Biotechnologies. 'Today's submission is the first step in that process, and we believe it will open the door to widespread use of our Lactoferrin test - and soon after, our IgE test - in primary eye care and beyond. We believe that securing CLIA waivers for our Lactoferrin and IgE tests will be transformative, unlocking significant commercial opportunities in the U.S. market and enabling earlier, more accessible diagnosis of Dry Eye Disease, including ADDE and ocular allergy. As a CLIA waived, semi‑quantitative, point-of-care biomarker test, TearScan Lf would be well-positioned to capture market share in the diagnostic device segment for Dry Eye.' About AXIM(R) Biotechnologies Founded in 2014, AXIM(R) Biotechnologies, Inc. (AXIM) is a vertically integrated research and development company focused on improving the landscape for the diagnosis of ophthalmological conditions such as Dry Eye Disease (DED) through rapid diagnostic tests. The Company owns two of the only five FDA Cleared Diagnostic tests for Dry Eye Disease. For more information, please visit Corporate/Media Contact Info: +1 858-256-5132 [email protected] Forward-Looking Statements The statements made by Axim Biotechnologies Inc., in this press release may be 'forward-looking' in nature within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. Forward-looking statements describe Axim's future plans, projections, strategies and expectations, and are based on assumptions and involve a number of risks and uncertainties, many of which are beyond the control of Axim Biotechnologies, Inc. Actual results could differ materially from those projected due to there being no assurance that our diagnostic candidate will ever be approved for use by the U.S. FDA or any equivalent foreign regulatory agency. Further, Axim's eye care diagnostic products that are FDA cleared may not be manufactured in large enough quantities or that third parties with established eye care physicians will enter into agreements or purchase from the Company, and even if the Company's diagnostic candidates are successful, they may generate only limited revenue and profits for the Company. Various other factors are detailed from time to time in Axim's Reports filed on Axim Biotechnologies, Inc., undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, unless otherwise required by law. View the original release on
The Advertiser
23-06-2025
- The Advertiser
Dreams, stars and magic in overdrive: is it time for some new ship names?
TREND WATCH Baby boomers are the wealthiest retiring generation in history, and many choose to splurge on experiences with loved ones. The CLIA State of the Cruise Industry 2025 report found 31 per cent of passengers are sailing with three to five generations of their family. Grandparents' main motivation is to create lasting memories. Cruising is popular because it simplifies logistics, with fares covering food, accommodation and activities for all ages. Where else can Grandpa nap by the pool while Grandma gets her hair done, Mum and Dad drink without driving, and the kids eat unlimited pizza?
Travel Weekly
22-06-2025
- Business
- Travel Weekly
Cruise industry navigates a new wave of port taxes
Cruise destinations are increasingly turning to taxes on ships or passengers to raise revenue to address the impacts of overtourism. Hawaii, Norway, Mexico and Skagway, Alaska, have all finalized new taxes on ships calling at their ports in recent months. The taxes are sometimes overtly earmarked to help the destinations recover costs associated with the post-pandemic flood of tourists, including their impacts on the local natural environment. In Hawaii, the tax revenue from cruise ships is being earmarked for environmental causes, be it park management or climate-resilient infrastructure. And in Norway, municipalities that want to implement the nation's new 3% tourism tax, which includes a cruise tax, will only qualify if they can show that tourists have caused strain on their municipal resources such as roads or park facilities, according to Forbes. While the Florida-Caribbean Cruise Association helped negotiate a lower tax rate for Mexico's new cruise tax, CLIA is fighting back by filing a lawsuit challenging Skagway's levy and is threatening to sue Hawaii. "If the cruise industry failed to challenge this surcharge, other states and municipalities could feel unconstrained in adopting similar unlawful surcharges, leading to exorbitant and ultimately untenable cruise fares," a CLIA spokeswoman said. Economics meet quality of life When introducing these taxes, destinations play a balancing act: They want to remain welcoming to tourists to reap the economic benefits, but they also want to keep the local residents content, said Jungho Suh, who teaches management at George Washington University. "The power to attract tourists or visitors to a local travel destination stems from the local community's welcoming hospitality, their friendliness, their kindness to visitors, which are deeply rooted in the local community's overall well-being," Suh said. "Their well-being has been negatively affected by the overtourism issues, especially since the beginning of the post-pandemic era. That's where the policymakers and lawmakers come along, to find that optimal point by understanding the sentiment and consensus of the local community, tourists and commercial cruise lines." In general, tourists entering a city by cruise spend less on land than other types of travelers, said Robert Rosen, a law professor at the University of Miami who teaches a course on the legal environment of the cruise industry. Taxes could be a way to make up for that lack of tourist revenue coming in despite thousands of people coming off of a ship, said Daniel Guttentag, director of the Office of Tourism Analysis at the College of Charleston. Since those paying the taxes are not residents and don't vote locally, lawmakers may sense fewer political repercussions than taxing their constituents, he said. Politicians "want to make sure they are able to be voted in again," said president Anthony Hamawy. "So, hey, let's go for the tourists. It's a softer hit." Cruise line consequences Since cruise lines have other options for visitation, they may begin to avoid taxed destinations. "There's a great deal of competition to get cruise ships to dock," Rosen said. "In Latin America, Mexico will compete with Guatemala. In the Caribbean, all the islands are competing with each other. So to impose a tax creates a disincentive to visit your country." CLIA was blunt about "unintended consequences for the local communities," including "lower spending by cruise guests when their cruise fare costs more and reduced visitation by cruise ships." Taxes may also incentivize cruise lines to dedicate more days to their private destinations or as sea days, said New York University's Richie Karaburun, a clinical associate professor at the Jonathan M. Tisch Center of Hospitality. When they can't avoid taxes, they'll either absorb the fees or pass them along to customers. The latter is more likely, he said. "If it's only one destination that adds in $5, $6, they might eat it up," he said. "If all of a sudden four ports added $6, that's $24, and if you look at it, that's $24 times 5,000 people each week. I don't think any cruise line could actually eat this up, and in the end, they're just going to have to put that back into their pricing."
Yahoo
18-06-2025
- Health
- Yahoo
Visby Medical secures $55m to expedite launch of women's sexual health test
Visby Medical has secured around $55m in its latest funding round, with the potential of reaching $65m, aiming to accelerate the launch and distribution of its at-home women's sexual health test. The test recently received authorisation from the US Food and Drug Administration (FDA). Spearheaded by Catalio Capital Management, the round also saw participation from current investors such as Cedars Sinai Medical Center, ND Capital, Blue Water Life Science Advisors, John Doerr and Pitango Ventures. The test claims to be the first single-use, disposable polymerase chain reaction (PCR) diagnostic that provides results in under 30 minutes via a connected smartphone app. This technology not only improves healthcare accessibility but also maintains patient privacy. The product is set to be available to consumers as of next month through direct-to-consumer channels. Visby also announced that Catalio partner Isaac Ro will join its board as an observer. Moreover, Chuck Alpuche, who currently serves as the chief operating officer (COO) at Imperative Care, will join as an independent director to the board of Visby. Visby Medical CEO and founder Adam de la Zerda said: "We are excited to partner with Catalio Capital Management, a true industry powerhouse, as we advance our mission to transform healthcare through rapid and convenient at-home diagnostics that deliver the same accuracy as traditional PCR machines. "This funding round will enable Visby to deliver on our vision of empowering consumers with reliable and lab-accurate health information from the comfort of their homes, starting with our at-home test for sexually transmitted infections (STIs) for women." Founded in 2012, Visby focuses on infectious disease diagnosis, enabling both physicians and patients to test for infections with lab accuracy. The company's portfolio includes the tests cleared by the US regulator for STIs for point-of-care and home use, as well as for respiratory infections such as Covid-19, flu A, and flu B. Earlier this year, the FDA granted 510(k) clearance and a Clinical Laboratory Improvement Amendments (CLIA) waiver for Visby's PCR test to detect respiratory infections. "Visby Medical secures $55m to expedite launch of women's sexual health test" was originally created and published by Medical Device Network, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
