TAMM Net, Inc. is a regulatory/quality and reimbursement consultancy serving biomedical manufacturers, headquartered in Atlanta, GA since 2009. Due to the Covid-19 pandemic, we are helping our clients and their communities across the country as a distributor for COVID-19 testing.
Our UK manufacturer is a long-standing client of TAMM Net’s. QuantuMDx is a not for profit funded by the British Government to develop the SARS-CoV-2 test. They filed an EUA 2 May 2020 and we expect approval by 1 June. This past week they received their CE-IVD mark. The MHRA Certificate of Free Sales officially allows QuantuMDx to export the tests. They have committed to 1 million units per week and can increase this by threefold, quickly. The RT-PCR test will work with any 96-well high throughput system.
This test targets three segments of the gene providing redundancy and improve detection of strain variants.
Show 98.89% concordance with a Sensitivity of 100% and a Specificity of 96.77%.
Our supplier for the SARS-CoV-2 IgG/IgM Rapid Test in China is Nanjing Norman Biological Technology Co., Ltd. They are approved to distribute to the US by the Chinese Government and are on the Coronavirus Reagent Test Kit whitelist. We notified FDA of our intent to file an EUA on Monday and anticipate an approval in early June from the FDA. They have committed to 1 million units per week and can increase, quickly.
IgG: Relative Sensitivity: 85.87% Relative Specificity: 100% Accuracy: 95.55% * 95% Confidence Interval
IgM: Relative Sensitivity: 95.65% Relative Specificity: 100% Accuracy: 98.63% * 95% Confidence Interval
Serology antibody tests detect the IgM and IgG antibodies that indicate your patient has developed an immune response to the virus. The test is intended to be used as a screening test. It is a POC (point of care) test that does not require sending samples to a lab. Therefore, the results can be obtained on-site.
Art Spalding, President of TAMM Net, has worked tirelessly over the years building relationships with best-in-class manufacturers around the world. Although the diagnostic distribution is a small part of what we do, we have the infrastructure to execute this kind of project, including customs brokers, warehousing, and call center capability. We can dropship or ship to a client’s distribution center.
We can sell both tests into the US, now! They are not EUA approved, but the tests have been cleared to sell in the US and we expect FDA to grant EUAs.
If you are interested in testing, please contact Betty Lou Anderson, Director of Business Development, firstname.lastname@example.org