Swedesboro, N.J.-based Thomas Scientific has partnered with Truckee Applied Genomics (TAG) to distribute its patient sample transport reagents. The new products are designed to address a full spectrum of molecular and protein lab testing risks made evident by the COVID-19 pandemic and the growth of the Delta variant.

Thomas Scientific has been appointed as the sole distributor for the U.S. and Puerto Rico of TAG reagents. The agreement provides an expanded distribution channel to research, diagnostic, and manufacturing customers, including clients in molecular pathology, diagnostic kit development, and variant tracking research labs, addressing testing lab risks.

With COVID-19 spread increasing from the Delta variant, demand for rapid antigen protein tests has surged and the need for broader NGS-based variant surveillance has become clear. As the diversity of testing has grown, it has become imperative that resources be designed to accommodate changing needs, while minimizing testing lab risks and maintaining lab worker safety.

One key factor for testing flexibility is enabling patient samples to be sent to any available lab without costly and error-prone cold chain shipping. Another key factor is designing in better safety from collection through lab processing, by inactivating virus before transport. With the growth of non-inactivating antigen tests kits, there is a clear need to develop new kits with reagents that inactivate virus to support safer handling.

Without virus inactivation, lab workers processing antigen tests face testing lab risks from viral exposure. While toxic guanidine-based virus-killing inactivating transport media (ITM) can preserve nucleic acids and be shipped without a cold chain, they do not work for antigen tests as they can denature proteins and interfere with rapid antigen testing mechanisms. And, for all test types, guanidine-based ITMs have safety and handling concerns as they produce toxic cyanide gas when used with bleach washing steps found in molecular testing processes and platforms including the Hologic Panther System as warned by the FDA.

TAG-NPGM+ and TAG-NGPM patient sample collection reagents contain no guanidine, which reportedly provides better choices. TAG-NPGM+ rapidly inactivates the virus (as shown by Rutgers University) while preserving both antigen proteins and viral nucleic acids. This means that a patient sample collected in TAG-NGPM+ for an antigen test, could also be sent for a positive verification by a gold-standard rt-PCR test, and banked for NextGen Sequencing (NGS)—enabling broader population variant tracking—and limiting testing lab risks.

Research Use Only (RUO) TAG-NGPM+ is a universal virus inactivating (safe) collection media that works end-to-end for antigen, rt-PCR and NGS tests, and enables lab staff to safely dispose of samples with common lab bleach. Research use and adoption by labs should follow FDA COVID-19 VTM guidance.

 “TAG is delighted to have Thomas Scientific distribute our products because of their deep technical understanding of the challenges of molecular diagnostics,” says Tian Yu, PhD, MBA, vice president of Product Development at Truckee Applied Genomics. “Along with Thomas Scientific, TAG is meeting the need to improve pandemic preparedness, testing safety, and accuracy, while enabling better and broader variant tracking. And beyond TAG-NGPM+, we are glad to be partnering with Thomas Scientific, to find high-potential new applications for the company’s non-crosslinking tissue stabilization reagent TAG-1 for oncology researchers, biotech companies, and innovative research labs to improve liquid biopsy, spatial genomics/transcriptomics, and biomarker development.”

Featured image: TAG-NGPM+ Next Generation Pathogen Media. Photo: Truckee Applied Genomics.