It has been approximately one month since the Company completed its processing requirements under the TBDx™ South African Evaluation Protocol. As mentioned in previous blogs, our processing of 1,249 TB suspect patients went extremely well and ended with our objective 100% completed. From that effort we published a previous blog about lessons learned that will benefit all parties involved.
The effort that remains is the completion of diagnostic efforts by the labs in South Africa and the ultimate release of the official results (or truth data). The remaining effort looks like the following:
- Microscopist Diagnostic Results – all microscopy reads have been completed and data is actively being entered into the Laboratory Information System so that results from all diagnostic processes can be properly correlated.
- Molecular DNA Diagnostic Results – approximately 50 cases remain to be processed.
- Culture Diagnostic Results (‘gold standard’) – culture takes the longest as any bacteria present in the sputum specimen must have an opportunity to grow and multiply. Culture results are anticipated to be available in the next week or two.
We expect to receive the microscopy and molecular DNA results before the culture results are completed. Those results could be available as early as next week.