SiMoA technology measures individual PSA molecules in prostate cancer patients: Nature Biotechnology

Quanterix Corporation, the single molecule diagnostics company focused on developing and commercializing high sensitivity tests, announced the publication of a breakthrough study of the company's proprietary technology that demonstrates an unprecedented sensitivity for measuring a biomarker for prostate cancer recurrence. The research article, featured on the cover of the June issue (Volume 28, No. 6) of Nature Biotechnology, describes how researchers developed a simple blood test using Quanterix's Single Molecule Array (SiMoA™) technology to selectively capture and measure individual Prostate Specific Antigen (PSA) molecules in prostate cancer patients.  The study showed that SiMoA was 1,700 times more sensitive than standard hospital tests, potentially allowing for detection of prostate cancer recurrence years earlier than current tests.

To demonstrate the clinical potential of SiMoA, PSA was measured in serum from men who had undergone radical prostatectomy for prostate cancer.  For the majority of these patients PSA is initially reported as undetectable following surgery, but may be present at very low levels that predict the likelihood of disease recurrence.  The Quanterix test was so sensitive that it was able to measure residual PSA levels in all samples tested.  The PSA levels had been reported to be undetectable in these samples by standard tests, highlighting the sensitivity and precision of the SiMoA technology.

"This paper demonstrates the extraordinary sensitivity provided by our SiMoA platform.  Its single molecule resolution has allowed us to measure PSA at extremely low levels, rather than having to wait until the cancer is more advanced," said Dr. David C. Duffy, Senior Director of Platform Research, Quanterix and corresponding author of the study.  "By using Quanterix's high density arrays, we were able to hone in on individual molecules rather than looking at the average response of thousands of molecules.  SiMoA provides the resolution for the proteome that the Hubble telescope did for the cosmos."

"A diagnostic test with this sensitivity may eliminate unnecessary secondary treatment while also providing significant peace of mind for the over 100,000 American men who annually undergo radical prostatectomy for the treatment of prostate cancer and who will ultimately remain disease-free," said Dr. Herbert Lepor, a prostate cancer expert and Chairman of the Department of Urology at the New York University School of Medicine.   "New York University Langonne Medical Center is looking forward to investigating the Quanterix test to determine its potential for identifying patients who require more or less vigilant follow-up after surgery and, identifying earlier those men who require secondary treatment, thereby optimizing postoperative management."

"The implications of this technology are far reaching," noted David Walt, Ph.D., scientific founder of both Quanterix and Illumina ( ILMN).  "In analytical chemistry, single molecule counting is the ultimate goal for sensitivity.  This report shows the applicability of SiMoA in measuring an important cancer marker and opens the door for its application in many other areas including neurological, cardiovascular and autoimmune diseases."  

"Quanterix has demonstrated conclusively that SiMoA can be applied to measuring any protein of interest with unprecedented sensitivity," said Dr. David Okrongly, President and CEO of Quanterix.  "Our goal is to utilize these data and other studies to launch our first diagnostic tests through the Quanterix Clinical Laboratory by 2011 and continue to advance the technology towards implementation across the full spectrum of immunodiagnostics."  

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