Genalyte

Fact Sheet

Our Immunoassay analyzer

MAVERICK

Our proprietary immunoassay analyzer, the MaverickTM Diagnostic System (MDS), uses silicon chip based photonic ring resonance technology to perform multiple, simultaneous, rapid tests on a small volume of whole blood or serum with results in approximately 20 minutes

25 Patent Issued and 19 Pending

Our proprietary Marverick™ Diagnostic System (MDS) has 25 patents issued and 19 patents pending worldwide.

 

FDA Clearance and EUA Authorization 

The MaverickTM Diagnostic System (MDS) received FDA clearance for RNP (ribonuceloprotein) assay in October 2019.

In addition, the MaverickTM Diagnostic System (MDS) received Emergency Use Authorization (EUA) by the FDA for SARS-CoV-2 Multi-Antigen Serology Panel in October 2020

Improving overall patient care

In order to improve overall patient care with rapid laboratory diagnostics, Genalyte became a clinical diagnostic provider receiving CLIA certification and CAP accreditation in 2017

Automated Lab solution

To service the ambulatory testing market, Genalyte developed a freestanding, temperature controlled and cloud connected automated laboratory (Merlin) that incorporates the MaverickTM Diagnostic System (MDS) along with a third party chemistry and hematology analyzer.

Merlin Test Menu

Over 89% of blood tests ordered in a typical Primary Care office is handled in < 30 minutes with the Merlin Platform

Central Lab Quality

All tests performed on-site are delivered to our CAP accredited and CLIA certified central lab via secure internet connection.

Clinical Lab Scientists oversee instrument monitoring and calibration as well as review test results before releasing them back to the physician.