JENSEN BEACH, Fla., April 11, 2017 /PRNewswire/ -- RTT MolecularDX USA, Inc. (RTTMDx) a provider of infectious disease Drug Resistance (DR) genotyping tests, announced today the pre-market launch of its Human Immunodeficiency Virus Type 1 (HIV-1), Hepatitis B Virus (HBV), and Hepatitis C Virus (HCV) Drug Resistance test and GeneTHINK® fully integrated system.
"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. With recent DAA FDA clearance and subsequent product insert indications for use of DR testing before administering Zepatier® (Merck) or Daklinza® (Bristol-Myers Squibb) we are confident our product is perfectly placed for immediate adoption," said Jennifer L. Wetshtein, President RTTMDx.
"For example, 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% of HCV type 1 virus," continued Wetshtein.
RTTMDx offers a complete CoreFLEX™ portfolio of products that includes screening and reflex confirmatory testing. RTTMDx intends to utilize the former TRUGENE® platform for a "bridging" 510K fast track strategy making regulatory application in 2017 with lead products including: GeneTHINK® CoreSEQ™ HIV-1 PR/RT DR Kit (former TRUGENE®), GeneTHINK® CoreSEQ™ HIV-1 pol (PR/RT/INT) DR Kit and GeneTHINK® CoreSEQ™ HCV NS5a DR Kit all running on a high performance Thin Slab Acrylamide Sequencing System (TSASS®) and integrated data management tools, VISGEN.
"The European model debuted at the New Micro Congress, Bardolino, Italy, March 29 - 30, 2017 was a great success. RTTMDx will formally launch the kits in the US at the ASM Clinical Virology Symposium, Savannah International Trade & Convention Center May 7-10 in Savannah, Georgia. The company is taking pre-orders on the kits, with expected delivery in late Spring", said Wetshtein.
ABOUT RTT MolecularDx
RTT MolecularDx (RTTMDx) was founded in June of 2015 to bring new innovative technologies and companion diagnostics to the forefront of treatment strategies for Infectious Disease. Headquartered in Jensen Beach, Florida. RTTMDx GeneTHINK System utilizes trusted technology, Standardized Chemistry "CoreCONCEPTS" and modularity. We offer a complete menu of CoreFLEX™ screening to confirmatory testing kits which utilize VISGEN intuitive integrated reporting systems to generate complete interpretive reports.
SAFE HARBOR STATEMENT
This press release includes forward-looking statements regarding events, trends and business prospects or regulatory timelines. Some of these risks and uncertainties include, but are not limited to, our ability to successfully commercialize our GeneTHINK® system and its related test menu in a timely manner. We assume no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made.
SOURCE RTT MolecularDx