The FDA has granted marketing clearance to this company for its FastPack System, a proprietary point-of-care blood testing system.
The system’s automated analyzer performs a broad menu of quantitative immunoassay tests in physician offices and small laboratories. The first test available will be a total prostate specific antigen for the diagnosis of prostate cancer, which also was cleared for U.S. marketing by the FDA.
With this system, physicians can obtain laboratory quality test results in less than 15 minutes, eliminating the need to send a patient’s blood sample to a commercial or hospital laboratory and wait several days for the results. In addition to the total PSA test, two other prostate cancer-related diagnostic tests, free prostate specific antigen and testosterone, are scheduled for introduction following FDA marketing clearance later this year.
The system consists of a diagnostic analyzer, less than a cubic foot in size, and single-use, disposable test packs. One-button operation makes it suitable for use by non-technical personnel.
The multichambered disposable plastic test pack contains the chemical reagents needed for a single test. The operator inserts the patient’s blood sample into the diposable test pack, loads the pack into the analyzer and the system automatically completes the test.
Qualigen
www.qualigeninc.com
keyword: point of care, analyzer
