RTT MolecularDx recently announced the pre-market launch of new genotyping tests to detect the presence of hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus type 1 (HIV-1), and the launch of its GeneTHINK fully integrated system.
According to the company, this is a first-of-its-kind kit combining drug resistance (DR) screening and sequencing, allowing for a more cost-effective treatment of infections with these viruses.
The use of molecular diagnostic testing platforms that use either genomic or proteomic technologies have increased dramatically. Currently the fastest growing business segment in clinical diagnostics, clinicians find these tests highly valuable in helping them select appropriate treatment strategies.
An accurate diagnostic testing of a specified type of HCV infection, for instance, is important for predicting the potential outcome or effectiveness of treatments.
Jennifer L. Wetshtein, the company president, said in a press release that “the implications for HCV are enormous, enabling patients to get the most efficacious treatment available with the potential to save hundreds of thousands of dollars in otherwise wasted treatments for HCV on drugs that have no effect on 25 percent of HCV type 1 virus.”
RTT MolecularDx offers a portfolio of products, including screening and confirmatory tests. The company’s GeneTHINK system uses reliable technology, consistent chemistry core concepts, and modularity.
The company intends to utilize the former TRUGENE genetic analysis platform (developed for the more effective management of treatable diseases) for a”bridging” 510k fast track strategy making regulatory application in 2017 with key products, namely the GeneTHINK CoreSEQ HCV NS5a DR Kit, among others. NS5a is an important gene for HCV replication, and mutations in this gene are known to result in viruses resistant to drug treatment.
“We are most excited about our new, first-of-its-kind, HCV DR Test for Replication Complex Inhibitors (RCI) drug resistance in the NS5a gene.” Wetshtein said.
According to the company, drug resistance (DR) testing should be performed before treatment is initiated.
RTT MolecularDx recently presented the European model of its technology at the New Micro Congress in Bardolino, Italy, March 29-30.
The debut was a great success, Wetshtein said. “RTT MDx will formally launch the kits in the U.S. at the ASM Clinical Virology Symposium, Savannah International Trade & Convention Center May 7-10 in Savannah, Georgia,” she added.
The company is taking pre-orders on the kits, with expected delivery in late spring.
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