Since 1988, every December 1st has been marked as World Aids Day. A day designated to show support for the fight against HIV, those people living with the virus, and commemorate those who have died from AIDS-related illness. According to the CDC, over 30,000 people in the United States were diagnosed with HIV in 2020. The most effected group are men in the LGBTQ+ community and are between the ages of 13-34 making up 57% of the HIV diagnosis in 2020.
The overall goal is to decrease new HIV cases to 9,588 by 2025 and 3,000 by 2030. To reduce the number of diagnoses, it is important to test at least once as part of the healthcare routine. However, those that are sexually active in high-risk groups may benefit from more frequent testing.
LaunchWorks molecular diagnostic products can be used for HIV detection or monitoring as a companion diagnostic for therapeutics. LaunchWorks CDMO partners with companies to develop and optimize diagnostic products for commercial, large-scale manufacturing. LaunchWorks provides an expansive list of services, from creating custom pilot lot kits for high complexity products to fully commercialized kitting and fulfillment. Custom solution formulations that meet your specifications produced under ISO 13485 quality standards to provide you increased quality assurance, material
traceability, and elimination internal manufacturing risk.
Additionally, LaunchWorks offers design and development services in lateral flow assays, sequencing, immunoassays, and molecular diagnostics, such as those used in fighting the spread of HIV/AIDS. For those in need of microfluidic device design, LaunchWorks leverages our partnership with the Canadian National Research Council (CNRC) and their new LIFT incubator space.
LaunchWorks establishes baseline product performance and sensitivity parameters to create component specific guard bands, which allow for early detection and prevention of performance issues during manufacturing.
The LaunchWorks’ Viral Transport Media (VTM) is listed per the FDA guidance under the “Enforcement Policy for Viral Transport Media during the Coronavirus 2019 (COVID-19) Public Health Emergency.” The VTM can be stored and transported in temperatures between 2-30°C for up to 24 months. The VTM and specimen collection products are designed to get your respiratory clinical sample to the diagnostic lab, without degradation.
LaunchWorks partners with companies to develop and optimize diagnostic products for commercial, large-scale manufacturing. All LaunchWorks products are manufactured under an ISO 13485 certified system and based on cGMP-compliant processes. Additionally, LaunchWorks provides an expansive list of services, from creating custom pilot lot kits for high complexity products to fully commercialized kitting and fulfillment.
LaunchWorks is proud to support companies in the fight to combat HIV/AIDS. For more information about how LaunchWorks supports partners in early detection in HIV, contact us here.
- FDA Registered
- ISO 13485:2016 Certified
- cGMP Compliant
- Contract Manufacturer