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The 10-Minute Revolution: LEX Diagnostics Poised to Transform Rapid Testing!

Harper Clark•Jun 9, 2025
A sleek, modern LEX VELO point-of-care diagnostic device in a busy clinic setting, with a healthcare professional easily inserting a cartridge, and a digital display prominently showing a rapid countdown timer or a clear positive/negative result.
  • LEX Diagnostics submits its groundbreaking VELO system for dual FDA 510(k) clearance and CLIA waiver.
  • The system promises lab-quality PCR results for key respiratory pathogens like flu and COVID-19 in a stunning six to ten minutes.
  • This move aims to revolutionize point-of-care testing, already attracting significant industry attention and acquisition interest.

The future of rapid medical diagnosis is knocking, and it's arriving with unprecedented speed. LEX Diagnostics, a dynamic innovator spun out from TTP Group1, 4, has just fired a starting gun in the race for faster, more accessible patient care. The company has boldly submitted dual applications to the FDA, seeking both 510(k) clearance and CLIA waiver status for its revolutionary VELO system. This ultra-fast molecular platform is engineered to deliver lab-quality PCR results for critical respiratory illnesses like Influenza A, B, and COVID-19 from a simple swab in a breathtaking six to ten minutes2, 4, 5.

This isn't just an incremental upgrade; it's a potential paradigm shift in point-of-care diagnostics. Fresh off successful U.S. clinical trials conducted during the demanding 2024/2025 respiratory season5, 6, LEX Diagnostics is executing its mission to "make molecular diagnostics faster, simpler, and more accessible," as CEO Ed Farrell emphatically stated. The VELO system is poised to redefine testing by equipping healthcare providers in primary care, urgent care clinics, pharmacies, and even decentralized acute settings with immediate, clinically actionable insights. This leap forward, enabling quicker decisions and improved patient outcomes, has not gone unnoticed. With plans to expand its test menu to include RSV and Strep A2, and significant acquisition interest reportedly shown by industry giants like QuidelOrtho4 highlighting its disruptive potential, LEX Diagnostics is on track to truly change the game. Healthcare professionals and patients alike can anticipate this diagnostic revolution reaching the U.S. market in late 2025 or early 2026.

References

  1. lexdiagnostics.com
  2. lexdiagnostics.com
  3. www.eu-startups.com
  4. www.quidelortho.com
  5. www.clinicallab.com
  6. www.globenewswire.com
  7. www.hasithreddy.com
  8. www.biospace.com

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