Platform
The Pandora CDx Point-of-Care System. POC Medical Systems has licensed 11 patents from Sandia and Lawrence Livermore National Labs. Its proprietary system uses antibodies to detect biomarkers using a novel and compact microfluidics system containing a built-in reading mechanism.
The Pandora CDx developed by POC Medical Systems is a microfluidic platform for rapid, point-of-care serum screening. It is based on a unique, low cost disposable microfluidic disk. The platform is a very simple and easy-to-use system which seeks to replace the previously mentioned laboratory ELISA-based screening technology. The technology provides for a simultaneous molecular test for the presence of 90 serum markers at the point of care and hence is ideal for screening capabilities for other life-threatening diseases like Cancer, Cardiovascular disorders, Infectious diseases etc.
It is also a highly efficient device as it is designed to produce reports at very low cost and in real time. Hence it could provide massive savings in terms of cost of diagnostics and treatment compared to traditional techniques. The system has the ability to send reports to caregivers directly from the device with the use of Wi-Fi. In addition, its handiness allows patients to get tested at home, store data via cloud for later use and also provides capability for continuous patient monitoring by care providers.
The Pandora CDx is a very simple to use systems which requires very minimal training.
- The lab technician or operator enters patients information on a tablet
- Pricks the patients finger with a lancet
- Applies the blood to the inlet in the disc where the blood has to be inserted
- Places the disc into the Pandora CDx
- Selects the test and presses Enter.
- The test is then performed on its own and the results are displayed and printed within 15 minutes.
- The disc is then removed from the Pandora CDx and disposed.
| Current Technology - $30K plus | Adaptability for screening | Pandora CDx – Less than $1K | Adaptability for screening | |
|---|---|---|---|---|
| Accuracy | High |  |
High | |
| Cost to patient | $1500 | X | <$5 | |
| Portability | Large foot print | X | Small foot print | |
| Training Level | Lab Trained | X | Minimal training | |
| Report | 24 to 36 hrs. | X | 10 mins | |
| Throughput | 1 to 2 Patients | X | 100 Patients | |
| Other Technologies like lateral flow systems and non optic i.e. Electrochemical systems are under development but are not able to offer any quantitative information and only provide a yes no result unlike the Pandora CDx, hence rendering them useless to provide data for course of treatment. | ||||
Breast cancer Test
The first product developed by POC is for screening of Breast cancer in women. Over 15 million cases of cancer are diagnosed worldwide and about 7.5 million lives are saved as a result of early diagnosis/screening. Only 60 million, or 3.8% of the 1.6 billion women eligible for breast cancer screening worldwide are actually screened. POC’s technology platform renders testing accessible to those 96.3% of women that need to be screened annually which translates into an implied market value of $3.2 billion worldwide.
Tests involving Biomarkers for various types of cancers have now been in use for a very long time. As an example PSA for Prostate cancer and even CEA and CA125 and HER 2 to determine what type of Breast cancer or Troponin for Cardiac etc. However, none of these can be used a true screening test as their accuracy is only in the range of 50% to 70%. Hence the need for a panel of biomarkers which can accurately diagnose / screen for a particular disease. POC Medical licensed the panel of markers developed by Lawrence Livermore Labs which when multiplexed provide an accuracy of over 90% unlike any other panel developed so far. The work done by LLNL was a very systematic approach to determining the right mix of Biomarkers needed. LLNL scientists reviewed the various pathways which trigger the formation of cancer cells / tumors in the breast. Based on this study it was determined the various protein Biomarkers that had to be targeted which resulted in over 25 different Biomarkers. These were then studied to understand the occurrence in various breast cancer patients and the various combinations of Biomarkers were evaluated.
Based on this data an alpha clinical study was conducted on a 120 known blood samples obtained from the Lombardi Cancer center. The multiplexed panel was used to determine the sensitivity and specificity of the test. The results are shown below:
| Results | ||
|---|---|---|
| Sensitivity | 0.91 | |
| Specificity | 1.00 | |
| Confidence Interval | 95% | |
| Prevalence / Predictive | 0.85 - 0.90 | |
The sample contained a mix of various Biomarkers and were obtained from patients who had undergone mammograms and biopsies to confirm if they had Breast cancer or not. Of the 120 Patients 20 had no Breast cancer and 100 had Breast cancer. Our test showed that of the 120 patients, the Panel accurately detected 90 patients with cancer and 30 were found not to have cancer. The panel accurately also found the 20 who did not have the cancer. However the Panel did miss 10 of the actual cancer cases. Further the panel did not pick any cancer cases from the 20 patients who had no cancer. Hence we can conclude the POC Medical Breast cancer Panel has a sensitivity of 0.91 and specificity of 1 which implies an accuracy of over 90% and a false positive rate of zero. This is higher than the standard of care and hence in our opinion could be used as a prescreening tool for breast cancer.