Genera currently have 3 additional AmpaSand MDx trials in its development pipeline, an overview of 2 of which is provided below. Our third trial in our development line remains confidential.
Genera aims to continue collaborating and partnering with existing pathology clients, as well as global IVD companies with credentials to accelerate the expansion of our development pipeline to 10 or more high-value AmpaSand MDx assays in the coming years.
STIplex is an 8 plex multiplex assay for common sexually transmitted infections that allows the detection and discrimination of five pathogens (Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV), Mycoplasma genitalium (MG), and Adenovirus types B, C, D and E (AdV) underlying a variety of common sexually transmitted diseases (STDs). The assay has a built-in confirmatory assay for Neisseria gonorrhoeae and is capable of identifying antibiotic (macrolide) resistant Mycoplasma genitalium species Most STDs are asymptomatic and some have high prevalence rates, and if left untreated, they can become a major cause of diseases such as PID (pelvic inflammatory disease), ectopic pregnancy, infertility, chronic pelvic pain, cervicitis, and urethritis.
Recently, the US Centers for Disease Control and Prevention updated (June 5, 2015) its sexually transmitted disease treatment guidelines to help healthcare professionals better manage the more than 20 million STD Cases in the US Annually.
The 2015 Sexually Transmitted Disease and Treatment Guidelines provide the first update since 2010. In particular, they include recommendations for the use of nucleic acid amplification tests for Trichomonas vaginalis (which is a target of STIplex) and routine detection of Trichomonas. for high-risk populations.
BBVplex is a 5-plexus multiplex assay for blood-borne sexually transmitted infections that allows the detection and discrimination of five pathogens HIV-1 Group M, HIV-1 Group O, HIV-2, Hepatitis B Virus (HBV), and Hepatitis C virus (HCV).
HCV infection is the most common chronic blood-borne infection in the United States, with approximately 2.7 million people living with a chronic infection.
Studies of HCV transmission between heterosexual or homosexual couples have yielded mixed results, but have generally found no or minimally increased rates of HCV infection in couples of people with HCV infection compared to those whose partners are not infected with HCV. However, data indicate that sexual transmission of HCV can occur, especially among HIV-infected people.
All people with HCV for whom their HIV and HBV infection status is unknown should be screened for these infections. As with our approach with our simultaneous HPV genotyping PapType assay, Genera’s approach with the design of our BBVplex assay provides a unique opportunity to improve economics for all stakeholders while providing better results for patients.