The Company's first product is the Platelet PGD Test. It has completed optimization, scale-up and internal as well as external studies at 3 major US hospitals. It has received 510(k) clearance from the FDA as a rapid, qualitative immunoassay for the detection of aerobic and anaerobic Gram-positive and Gram-negative bacteria in leukocyte reduced apheresis platelets (LRAP) as an adjunct quality control test following testing with a bacterial detection device cleared by the FDA for quality control testing of LRAP. The test consists of a disposable plastic cartridge that can be stored at room temperature and three dropper bottle sample pretreatment reagents. The Platelet PGD test procedure involves pre-treating a freshly collected 500uL platelet sample and applying it to the sample well on the test cartridge. Within approximately 20 minutes of sample addition, a pink colored bar will appear in one of the two reading windows on the test cartridge if either Gram-positive or Gram-negative bacteria are detected in the sample above the cut-off level of the assay. Non-reactive samples show no color bar in the read windows. Procedural Controls which change from yellow to blue violet when the test is ready to be interpreted are included at each end of the test cartridge. These allow visual confirmation that the appropriate volume of sample was added to the cartridge and that the test has run to completion.
Verax's PGD tests are being designed to meet all of the critical requirements for blood component bacterial detection:
- Broad detection — only one test to detect a wide variety of bacteria
- Sensitive — typically detects bacteria at 103 - 105 CFU/mL
- 99.8% specificity — based on the repeat reactive rate in LRAP units
- Rapid results — results typically available within 30 minutes
- Ease of use — less than 3 minutes of attended labor per test
- Small sample size — only 500 uL
- No dedicated instrument required — simple visual results
- Built in procedural controls — confirm sample addition and test completion
During preclinical studies:
In an in-house study, 4 contaminated platelet units were detected by a prototype Platelet PGD Test in a mixed population of 7,889 apheresis and whole blood derived platelets. All 4 units confirmed as contaminated by culture testing.
No significant cross reactivity issues were observed with the test typically demonstrating a specificity of approximately 99.7%.
