Genalyte

09/12/2025

We are looking for blood donors with one of the following conditions to help in studies to show the accuracy of our device.

Diabetes ∙ Kidney Disease ∙ COPD ∙ Active Cancer ∙ Liver Disease ∙ Thyroid Disease ∙ Autoimmune Disease (arthritis/lupus) ∙ Infection (viral/parasitic)

It will take just 15 minutes of your time and donors will receive a $40 Amazon Gift Card as ‘thank you.’

Sign up here:
https://calendar.google.com/calendar/u/0/appointments/schedules/AcZssZ25nWwRCjHLTThEUlpEiFqS4X4nLlN4zgWFu2B1FIMl9kAXEzHzYRP7ZQiL6FrXUqRHUjO66zyJ

04/22/2025

Draw, Drop, Done. Adam Bonislawski from 360Dx explores how Genalyte’s Merlin is set to transform the lab testing experience for patients and providers.

The company has completed its FDA submission for the system and inked a deal with UAE-based healthcare provider Burjeel Holdings to deploy the system in its facilities.

04/16/2025

Big news from : Genalyte and Burjeel Holdings have announced a strategic partnership to bring the Merlin diagnostic platform to hospitals and clinics across the MENA region.

Pending FDA clearance, Merlin will be deployed across Burjeel’s network to deliver same-visit, high-quality lab results in under 30 minutes—supporting faster, more accessible care, especially in remote and underserved areas.

🔗Read the Full Release Here: https://www.genalyte.com/2025/04/16/burjeel-holdings-and-genalyte-announce-strategic-partnership/

Abu Dhabi, UAE – April 16, 2025 — Burjeel Holdings, one of the leading private healthcare providers in the MENA region, and U.S.-based diagnostics company Genalyte announced a strategic partnership during the Abu Dhabi Global Health Week. The collaboration centers on the deployment of Genalyte.....

03/26/2025

We’re proud to share that Genalyte has officially submitted the Merlin fully-automated laboratory to the FDA for premarket clearance, covering a menu of 39 analytes, with more to come!

This marks a major step forward in our mission to bring real-time diagnostics to the point of care — and it's the result of incredible collaboration across our clinical, regulatory, engineering, and operations teams.

A heartfelt thank you to everyone who poured their energy, expertise, and late nights into making this submission possible. We couldn't be more excited about what's ahead for the company and patients.

Onward! 🚀

02/11/2025

Excited to announce that our CEO, Ashraf Hanna, will present at Biocom California’s Global Life Science Partnering & Investor Conference! Discover how Merlin—our automated lab designed to perform 90% of routine tests on site with results in under 30 minutes—is revolutionizing diagnostics.

07/23/2024

Genalyte has received the FIRST FDA clearance for a rapid, quantitative Immunoassay test performed on a silicon chip! 🎉 This Thyroid Stimulating Hormone (TSH) assay is a monumental step forward for us and the entire diagnostic industry.

With this breakthrough, TSH testing can now be done in approximately 30 minutes, compared to the traditional 2-5 days. This means faster diagnosis and quicker treatment for the 10% of Americans affected by hypothyroidism.

Our revolutionary Maverick system, weighing only 30 lbs and the size of a small microwave, delivers central lab quality results and is poised to transform lab care just as silicon chips revolutionized computing.

Read the full press release here: https://www.genalyte.com/2024/07/22/fda-clears-genalytes-tsh-assay/

06/18/2024

Our second study is underway and we are offering a $40 Amazon gift card to volunteer blood donors in our San Diego office who have not donated to our studies since May 5, 2024. Take 15 minutes to help Genalyte transform laboratory care!
Sign Up Here:

05/24/2024

Thank you F6S for naming Genalyte #2 in the top 100 Top Healthcare Companies and Startups in California! We’re working on taking the #1 spot next year 🚀

Explore top companies and startups in California - 2023 | Complete and updated collection and list of Healthcare startups, companies, organizations | F6S

04/22/2024

Catch our CEO Ashraf Hanna in conversation with Seed Healthcare's CEO Todd Perman as they discuss how Genalyte is transforming laboratory testing with the Merlin platform. 🚀Click to read the full story: https://seedhealthcare.com/portfolio-company-spotlight-genalyte-and-qa-with-ceo-ashraf-hanna/

04/10/2024

Happy Laboratory Professionals Week to the brilliant minds and skilled hands at Genalyte. Your tireless efforts ensure accuracy and reliability in every test. Thank you!