Genalyte recently presented promising data on its new Maverick Detection System, demonstrating its potential to be used in a near patient setting to improve turnaround time for test results and diagnosis for several conditions, including rheumatoid arthritis (RA).

 

Genalyte funded two pilot studies to evaluate the Maverick platform in rheumatology offices. Results of the two studies were presented at the 2016 American College of Rheumatology (ACR)/Association of Rheumatology Health Professionals (ARHP) annual meeting in Washington, D.C.

 

The results were revealed in two poster presentations titled “Near Patient Anti-Nuclear Antibody Multiplex Testing Using Whole Blood for the Diagnosis of Connective Tissue Diseases in a Tertiary Care Center,” and “Application of a Novel Anti-Nuclear Antibody Multiplex Test Using Finger Stick and Venous Whole Blood in a Rheumatology Clinic – Demonstration of Feasibility.”

 

The detection of anti-nuclear antibodies (ANA) is a common practice for the diagnosis of connective tissue diseases, including RA, systemic lupus erythematosus (SLE), Raynaud’s phenomenon, systemic sclerosis, and others.

 

However, complex algorithms are required to obtain conclusive results. The Maverick system simplifies the detection of auto-antibodies and allows results to be available in 10 to 30 minutes, depending on the type of assay performed.

 

Dr. Smitha Reddy, PhD, medical director of the Arthritis Care and Research Center of San Diego, and Dr. Makoto Miyara, PhD, from Genalyte, presented the posters at the ACR/ARHP meeting.

 

The two studies combined tested more than 750 patients over four months and compared real-time results of the Maverick Detection System with those obtained with standard lab procedures and patient diagnosis.

 

The two studies’ main conclusions were:

  • The feasibility of performing multiplex ANA testing on whole blood in a near patient setting was successfully demonstrated;
  • The Maverick system was found to be potentially useful in an outpatient setting to improve turnaround time for diagnosis and to increase proximity of patient testing (near-patient in the physician office).

The researchers also found:

  • An importantly high correlation between positive and negative results when comparing whole blood tested with the Maverick platform with serum tested using previously approved devices;
  • An importantly high correlation of test results between venous draw and finger-stick blood samples.

According to a press release, Reddy said that the studies demonstrated “the feasibility of performing multiplex ANA testing on whole blood in a near patient setting in an outpatient clinic,” and that “there is high correlation between venous blood and finger-stick blood, and between positive and negative results on the Maverick and comparative devices.”

 

Rick Hockett, PhD, Genalyte’s chief medical officer, said he was pleased with the results.

 

“Dr. Reddy’s presentation of in-office clinical trial data as well as independent validation data from Dr. Miyara’s group at le Pitié-Salpêtrière Hospital demonstrate Genalyte’s commitment to engaging in the clinical peer review process for the evaluation of our novel diagnostic platform,” Hockett said.

 

“Genalyte’s goal is to put a rapid and powerful suite of diagnostic tests in every physician’s office,” said Cary Gunn, PhD, Genalyte’s founder and CEO.

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