High-Sensitivity Immunodiagnostics (Digital ELISA)

Prostate Cancer Recurrence Monitoring

Alzheimer's Disease (AD)

Features and Benefits of SiMoA™ Platform

SiMoA™ Assays

Prostate specific antigen (PSA) is one of the most-ordered diagnostic tests. Its use for prostate cancer screening represents over 80% of the tests performed. Patients who have had their prostate surgically removed to treat biopsy-confirmed cancer, a procedure called radical prostatectomy (RP), are also monitored using the standard PSA test. Within a few weeks following surgery, PSA levels should become “undetectable” using standard hospital laboratory tests. The first sign of relapse in the majority of men treated by prostatectomy is a rising PSA level without clinical evidence of disease, an event known as biochemical recurrence. The sensitivity of existing commercial PSA assays is not low enough to catch the first indication of a rising PSA level in post-RP men, thus delaying detection of recurring disease by months or years.

Utilizing Quanterix’s AccuPSA™ test, a more than 1000-fold improvement in assay sensitivity has been achieved, allowing physicians to:

• Identify men who have a low probability of recurrence (good prognosis) within a few months following surgery based on a very low PSA value

• Identify individuals at increased risk for future recurrence who are more likely to benefit from early adjuvant or salvage therapies based upon rising PSA levels during post surgery monitoring

Use of the AccuPSA test in clinical practice has potential implications for frequency of PSA testing, selection of candidates for adjuvant therapy, and reassuring a large subset of men that they are not at risk of recurrence. With funding from the National Cancer Institute, Quanterix recently completed a clinical study to validate this test.