Category: Uncategorized

June 6, 2025 – 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.

 

[1]  This LEX Diagnostics product is currently under development and has not been cleared or approved by the U.S. Food and Drug Administration or any other regulatory authority. It is not available for sale or distribution in the U.S., the U.K. or any other jurisdiction. All product descriptions, data, or discussions are preliminary, subject to change, and do not represent final or FDA-approved claims, indications, or labeling.

Cambridgeshire UK, 18 July 2023 – LEX Diagnostics (LEX) today announces the appointment of Dr Heather Danks as its Chief Technology Officer (CTO). The company is revolutionising point-of-care molecular diagnostics with a step change in speed, sensitivity, and cost. LEX is developing a 5-minute multiplex PCR test to quickly determine the presence of a wide variety of common infectious diseases, including influenza and COVID-19.

LEX Diagnostics’ new CTO Dr Heather Danks, who has been promoted from her position of VP Molecular Development at the company, commented, “I am excited to embrace the role of CTO and support the team in the development of the LEX platform. We have core technology and reagents capable of re-defining PCR diagnostics at the point of care. I look forward to developing the LEX platform to harness the full potential of our technology and reagents and to put a strategic road map in place to enable significant impact in healthcare.”

LEX Diagnostics’ CEO Ed Farrell said, “I’m pleased to announce Heather as our CTO who will be responsible for leading the development of the LEX system and the future development strategy for the LEX platform. Heather’s leadership will be invaluable as we move the platform into the next stage of clinical development in ‘flu and COVID-19. We have an experienced and diverse team at LEX committed to the common goal of bringing our innovative thermal cycling technology, coupled with  our proprietary inhibitor tolerant reagent, to the healthcare market.”

Heather Danks is a molecular biologist with a PhD in Genetics and Cellular Biology from Newcastle University, UK. Prior to joining LEX in 2020, Heather held various roles within QuantuMDx, including Head of Assay Development where she focused upon development of a point of care diagnostics platform and accessory technologies for advanced sample preparation for various infectious disease targets.  Heather builds on a decade of experience in assay and device development from feasibility to product launch and has lead collaborations with industry, academia and the NHS.

LEX Diagnostics will be at the annual AACC meeting from 23-27July in Anaheim, California, on booth 2662. To arrange a meeting with Heather Danks, Ed Farrell, and colleagues, contact us on [email protected].

LEX Diagnostics announces the appointment of Scott O’Brien as its new Board member.

The company is revolutionising molecular point-of-care diagnostics with a step change in speed, sensitivity, and cost. LEX is developing a 5-minute multiplex PCR test to quickly determine the presence of infectious diseases including SARS-CoV-2 (Covid-19), Influenza, Strep A, and RSV.

LEX Diagnostics’ new board member, Scott O’Brien, commented on his appointment, “I am delighted to be joining the LEX Diagnostics board. Our 5-minute PCR test has the potential to be game changing for healthcare providers thanks to its unique ability to gain accurate and fast clinical insights. I look forward to using my expertise to support the LEX team to bring this thermocycling technology to the healthcare market and see it translate into improved patient care.”

LEX Diagnostics’ Chair of the Board, Dr Andrew Baker-Campbell, said, “It’s a pleasure to welcome Scott to LEX Diagnostics on behalf of the company. His track record of commercially developing fellow diagnostic companies is of great value as we push towards taking our innovative PCR technology to market. I look forward to seeing our progress accelerate under this growing team of expert staff and board members.”

Scott is a senior business leader with over 25 years of global life sciences and diagnostics industry experience across numerous roles from R&D, to marketing and commercial and C-suite. Scott has cemented his experience in the diagnostics field, most recently for Specific Diagnostics and GenMark Diagnostics, where he not only led corporate and commercial strategies towards and after product launch, but was also instrumental in the acquisition of both companies by pharma. Scott acquired his Bachelors in Microbiology from the University of Wisconsin-Madison and joins the board from San Diego, USA.

The company is revolutionising molecular point-of-care diagnostics with a step change in speed, sensitivity, and cost. LEX is developing a 5-minute multiplex PCR test to quickly determine the presence of infectious diseases including SARS-CoV-2 (Covid-19), Influenza, Strep A, and RSV.

LEX Diagnostics’ new CEO, Ed Farrell, commented on his appointment, “I’m thrilled to join the talented team at LEX and to work toward launching our 5-minute multiplex PCR test. Our goal is to rapidly bring our innovative thermocycling technology to the healthcare market, improving patient care worldwide and opening the door to syndromic testing by bringing the necessary clinical insights to healthcare providers within minutes.”

LEX Diagnostics’ previous CEO and now Chair of the Board, Dr Andrew Baker-Campbell, said, “On behalf of the company, I welcome Ed to LEX Diagnostics. He brings an abundance of operational experience from his successful career spanning the diagnostics and medtech industry. We are confident Ed will drive the translation of our technology into a commercial product. I look forward to continuing my role as Chair of the Board, overseeing the strategy of this innovative and exciting molecular diagnostics company.”

Ed brings over 25 years of life science experience gained through senior industry roles with an emphasis on medical devices and diagnostics. Immediately prior to joining LEX Diagnostics Ed was COO of Klay Biotech. From 2013 to 2021 Ed served as President/COO of Quotient Ltd where he led the development and realisation of the MosaiQ platform from concept to commercialisation. He also played a significant role with Quotient’s IPO on Nasdaq. Prior to Quotient, Ed held senior positions in operations in the UK, USA, and Ireland with Siemens Healthcare Diagnostics. He holds a degree in Mechanical Engineering, and a Masters degree in Engineering Science, from University College Dublin.