LEX Diagnostics Submits Dual Applications for FDA 510(k) Clearance and CLIA Waiver for Groundbreaking LEX VELO System
CAMBRIDGESHIRE, United Kingdom, June 06, 2025 (GLOBE NEWSWIRE) — LEX Diagnostics, a leading innovator in molecular diagnostics, has submitted dual applications to the U.S. Food and Drug Administration (FDA) seeking 510(k) clearance and CLIA waived status for its VELO system, an ultra-fast point-of-care molecular diagnostics platform designed to deliver highly sensitive PCR results for key respiratory pathogens directly from a swab sample in under ten minutes.1
The FDA submission represents a pivotal step in LEX Diagnostics' strategy and underscores the company's commitment to advancing point-of-care testing with accurate, timely, and clinically actionable results.
'This milestone reflects the strength of our R&D and clinical validation programs, as well as our broader mission to make molecular diagnostics faster, simpler, and more accessible,' said Ed Farrell, Chief Executive Officer of LEX Diagnostics. 'We believe the LEX VELO system will redefine point-of-care testing by equipping healthcare providers with lab-quality results in minutes, enabling faster clinical decisions and improved patient outcomes without compromising quality while improving workflow—an achievement that will set us apart in the marketplace.'
The LEX system supports multiplex testing for key respiratory pathogens, including Influenza A, Influenza B, and COVID-19, and is engineered to deliver PCR results in six to ten minutes, easily integrating into clinical workflows across primary care settings, urgent care clinics, pharmacies, physician office laboratories and decentralized acute settings. Its proprietary cartridge-based design eliminates the need for external liquid handling, promoting ease of use and reliability. LEX recently completed clinical studies in the United States with the VELO system and the Influenza/Covid assay during the 2024/2025 respiratory season.
LEX Diagnostics anticipates U.S. market clearance in late 2025 or early 2026, in alignment with expected FDA review timelines.
About Lex Diagnostics
LEX Diagnostics, a TTP Group Company, is a molecular diagnostics company transforming point-of-care testing through its proprietary ultra-fast thermal cycling technology. Designed to deliver lab-quality PCR results directly from a swab sample in minutes, the VELO system bridges the gap between accuracy and accessibility, empowering healthcare professionals to make informed clinical decisions faster. LEX Diagnostics is headquartered in Cambridgeshire, United Kingdom.
Learn more at www.lexdiagnostics.com and follow us on LinkedIn.
Forward-Looking Statements
This press release contains forward-looking statements, including but not limited to, statements regarding product development, regulatory timelines, market potential, and expected outcomes. These statements are based on current assumptions and expectations that are subject to risks, uncertainties, and changes in circumstances. Actual results may differ materially from those expressed or implied in forward-looking statements due to a variety of factors, including regulatory decisions, market conditions, and operational challenges.
LEX Diagnostics undertakes no obligation to update or revise any forward-looking statements made herein, except as required by law.
Media Contacts
LEX Diagnostics
Chris Hole
[email protected]
Scius Communications
Katja Stout+44 778 943 5990
[email protected]
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
The Hill
an hour ago
- The Hill
Why Musk's feud with Trump could jeopardize his business empire
Elon Musk, the world's richest man, may have made himself an enemy of the world's most powerful leader. The public blowout between Musk and President Trump is threatening the tech billionaire's businesses, some of which have billions of dollars' worth of federal contracts. Musk's aerospace company SpaceX alone reportedly has at least $22 billion in federal contracts — which Trump had threatened to revoke at the peak of his feud with his former adviser. 'Trump goes after people, companies and organizations he doesn't like,' said Peter Loge, a professor at George Washington University and former senior FDA adviser during the Obama administration. 'As a real estate developer, politician and president, he has used every tool at his disposal to punish people he thinks have wronged him,' Loge added. 'Unless Musk expresses contrition, Trump is likely to hurt him in every way he can think of. If Musk is contrite, he can be welcomed back into the Trump tent.' While the two could reconcile in the future, observers agree the dramatic turn of events leaves Musk's business empire vulnerable to Trump's wrath. Trump, at one point during Thursday's back-and-forth, threatened to cut Musk's government contracts as he called his former adviser 'crazy.' 'The easiest way to save money in our Budget, Billions and Billions of Dollars, is to terminate Elon's Governmental Subsidies and Contracts. I was always surprised that Biden didn't do it!' Trump wrote in a Truth Social post. Musk, in turn, said he would decommission SpaceX's Dragon spacecraft, which is responsible for ferrying astronauts and cargo to and from the International Space Station. He later backed off, after an X user urged him to 'cool off and take a step back.' The exchange underscored how Musk's business ventures could get caught in the crosshairs of any feud with the president, who is known to have a proclivity for retribution. 'If this turns into a hot war, certainly, the consequences for Musk's business relationship with the federal government could be in peril, or at least significantly complicated,' said GOP strategist and Trump campaign alum Brian Seitchik. The tech billionaire officially departed the White House last week after a four-month stint in government in which he seemed to rarely leave Trump's side, becoming a near constant presence at Mar-a-Lago, Cabinet meetings and the Oval Office. He exited the administration seemingly on good terms with Trump despite his pushback against the president's sweeping tax and spending bill — the centerpiece of Trump's domestic policy agenda, which is projected to add trillions of dollars to the deficit. Trump presented Musk with a golden key to the White House during a Friday farewell ceremony in Oval Office, during which the duo downplayed their differences and spoke highly of each other's work. However, Musk sharpened his criticism of Trump's 'big, beautiful bill' soon after, as he slammed the legislation as a 'disgusting abomination.' The president responded Thursday, saying he was 'very surprised' and 'disappointed' by Musk's comments and cast doubt on the future of their relationship. 'Elon and I had a great relationship. I don't know if we will anymore,' Trump said during an Oval Office appearance alongside German Chancellor Friedrich Merz. The situation quickly devolved into personal attacks. Musk fired back on his social platform X, suggesting the president would have lost the 2024 election without him, linking Trump to disgraced financier Jeffrey Epstein and backing calls for the president's impeachment. As the feud dragged on Thursday, Tesla's stock plunged 14 percent Thursday, costing the electric vehicle maker more than $150 billion. The company was still trying to fully recover from the fallout of Musk's highly controversial role in the Trump administration, leading the Department of Government Efficiency (DOGE). Tesla's stock is down 20 percent since the start of the year. 'The social media and war of words back and forth is not good for anyone and put massive pressure on Tesla shares with fears that Trump will turn from friend to foe and create a tough regulatory environment for Musk in the Beltway,' Wedbush Securities analysts wrote in a note Friday. 'Musk needs Trump and Trump needs Musk for many reasons, and these two becoming friends again will be a huge relief for Tesla shares,' they added. Ross Gerber, a longtime Tesla investor and CEO of Gerber Kawasaki Wealth and Investment Management, slammed Musk for the ripple effects his comments may have had on Tesla's stock. 'Trump is an angry and vindictive man who doesn't forget when slighted. This doesn't get solved other than Elon groveling back and publicly apologizing,' Gerber wrote on X Friday, adding in an earlier post, 'So Tesla investors are down $140 billion over this break up. About how much Musk claimed to saving for the US government.' As the back-and-forth unfolded Thursday, Gerber quipped, 'Can someone please take the phone away from him [Musk].' When pressed on the feud, White House press secretary Karoline Leavitt said Musk has a right to speak for his companies. 'So the only difference between Friday and today is Elon went back to his companies. And, as a businessman, he has a right to speak for his companies. But as president, President Trump has a responsibility to fight for this country,' she said Thursday on FOX News Channel's 'Hannity.' While Trump could pose new risks to Musk's business outlooks, analysts say the fight could also impede the president's ability to run the government. SpaceX held federal contracts with agencies like NASA and the Pentagon long before Trump's presidency, becoming a crucial partner to the federal government as it phased out the space shuttle program. If Musk reverses on his decision to keep Dragon in commission, experts say it could debilitate the U.S. space program 'If such threats were carried out, it would be catastrophic,' said space policy expert Mark Whittington, adding later, 'Without SpaceX, we're back to being dependent on the Russians.' NASA has increasingly relied on SpaceX for its infrastructure, including the Dragon capsule, which is the only U.S. system capable of getting crews to the International Space Station. Russia's Souyuz capsules, the Associated Press reported, are the only other way to get crews to the space station. While both Trump and Musk have much to lose from a war, some Republicans veterans aren't ruling out the chance of a reconciliation. 'There's always the possibility that Trump is serious about this, but I think if you take the 'Art of the Deal' seriously, he is often maximally negotiating,' said GOP strategist Chris Johnson. The feud appeared to cool slightly Friday morning, as Musk seemingly agreed with a post from hedge fund manager Bill Ackman, who suggested the pair 'should make peace for the benefit of our great country.' But Trump has shown no desire to talk to Musk despite reports the two might speak on the phone. 'I won't be speaking to him for a while, I guess, but I wish him well,' Trump told CNN's Dana Bash on Friday. Tesla's stock partially recovered amid hopes of a détente, rising 5 percent. 'If Musk is able to sue for peace and the onus is on him to make peace with Trump, then it'll be a blip in the screen and their bromance will be restored,' Seitchik told The Hill. However, he added, 'If this call goes poorly and this continues to escalate, then certainly Trump will look for every bit of leverage to inflict pain on Elon Musk and his businesses.'
Business Upturn
3 hours ago
- Business Upturn
ProZenith Launches Natural Supplement Formulated for Weight Management Support
By GlobeNewswire Published on June 7, 2025, 06:50 IST Aurora, June 06, 2025 (GLOBE NEWSWIRE) — ProZenith recently announced the launch of its new wellness supplement developed to assist individuals in maintaining energy, focus, and mindful appetite awareness as part of a balanced and active lifestyle. Manufactured in the United States in a facility that is FDA-registered and GMP-certified, the product is now available through official online channels. ProZenith is intended for individuals pursuing support for general weight management and overall well-being. Its formulation includes select ingredients chosen to align with healthy routines and support individuals seeking help managing non-hunger-related snacking behaviors. Each purchase of ProZenith is covered by a 60-day refund policy, reflecting the company's customer-first return assurance framework. All ProZenith supplements are manufactured without genetically modified ingredients and adhere to U.S. quality standards. Production takes place in an FDA-registered facility that complies with current Good Manufacturing Practices (cGMP). ProZenith is currently available through the company's official online platform at with multiple purchase options provided for convenience. About ProZenith ProZenith develops nutritional supplements designed to support individuals on their wellness journeys. The company emphasizes high-quality manufacturing, transparency, and customer satisfaction as it continues to expand its product offerings for health-conscious consumers. For customer support inquiries, contact: [email protected] Disclaimer: This product has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease. Media Contact: Company: ProZenith ProZenith Address: 19655 E 35th Dr #100, Aurora, CO 80011 19655 E 35th Dr #100, Aurora, CO 80011 Email: [email protected] [email protected] Order Phone Support: (925) 217-7353 Disclaimer: The above press release comes to you under an arrangement with GlobeNewswire. Business Upturn takes no editorial responsibility for the same. GlobeNewswire provides press release distribution services globally, with substantial operations in North America and Europe.
Business Upturn
3 hours ago
- Business Upturn
Grupo Aeroportuario Del Pacifico Announces Approval Of Maximum Tariffs And Capital Development Program For 2026-2030 For Montego Bay Airport In Jamaica
By GlobeNewswire Published on June 7, 2025, 08:25 IST GUADALAJARA, Mexico, June 06, 2025 (GLOBE NEWSWIRE) — Grupo Aeroportuario del Pacífico, S.A.B. de C.V. (NYSE: PAC; BMV: GAP) ('the Company' or 'GAP') announces the conclusion of the ordinary review process for the maximum tariffs per passenger and committed investments included in the Capital Development Program of Montego Bay for the 2026–2030 period. The maximum passenger charges are expressed in U.S. dollars and will apply to each year as specified in the following table: Airport 2026 2027 2028 2029 2030 Montego Bay 17.38 17.79 18.22 18.65 19.07 The investments approved by the Authority and committed under the Capital Development Program are expressed in millions of U.S. dollars and must be deployed according to the following schedule: Airport 2026 2027 2028 2029 2030 Total Montego Bay 38.4 39.4 18.4 11.6 10.3 118.1 Company Description Grupo Aeroportuario del Pacífico, S.A.B. de C.V. (GAP) operates 12 airports throughout Mexico's Pacific region, including the major cities of Guadalajara and Tijuana, the four tourist destinations of Puerto Vallarta, Los Cabos, La Paz and Manzanillo, and six other mid-sized cities: Hermosillo, Guanajuato, Morelia, Aguascalientes, Mexicali, and Los Mochis. In February 2006, GAP's shares were listed on the New York Stock Exchange under the ticker symbol 'PAC' and on the Mexican Stock Exchange under the ticker symbol 'GAP'. In April 2015, GAP acquired 100% of Desarrollo de Concessioner Aeroportuarias, S.L., which owns a majority stake in MBJ Airports Limited, a company operating Sangster International Airport in Montego Bay, Jamaica. In October 2018, GAP entered into a concession agreement for the Norman Manley International Airport operation in Kingston, Jamaica, and took control of the operation in October 2019. This press release may contain forward-looking statements. These statements are statements that are not historical facts and are based on management's current view and estimates of future economic circumstances, industry conditions, company performance, and financial results. The words 'anticipates', 'believes', 'estimates', 'expects', 'plans' and similar expressions, as they relate to the company, are intended to identify forward-looking statements. Statements regarding the declaration or payment of dividends, the implementation of principal operating and financing strategies and capital expenditure plans, the direction of future operations, and the factors or trends affecting financial condition, liquidity, or results of operations are examples of forward-looking statements. Such statements reflect the current views of management and are subject to a number of risks and uncertainties. There is no guarantee that the expected events, trends, or results will occur. The statements are based on many assumptions and factors, including general economic and market conditions, industry conditions, and operating factors. Any changes in such assumptions or factors could cause actual results to differ materially from current expectations. In accordance with Section 806 of the Sarbanes-Oxley Act of 2002 and Article 42 of the 'Ley del Mercado de Valores', GAP has implemented a 'whistleblower' program, which allows complainants to anonymously and confidentially report suspected activities that involve criminal conduct or violations. The telephone number in Mexico, facilitated by a third party responsible for collecting these complaints, is 800 04 ETICA (38422) or WhatsApp +52 55 6538 5504. The website is or by email at [email protected]. GAP's Audit Committee will be notified of all complaints for immediate investigation. Disclaimer: The above press release comes to you under an arrangement with GlobeNewswire. Business Upturn takes no editorial responsibility for the same. GlobeNewswire provides press release distribution services globally, with substantial operations in North America and Europe.
