BioSynchronicity is an agile company with a well-balanced and experienced professional team having in-depth business expertise in technology development, healthcare delivery, and international trade.
Keep Our Communities Safe
half-century have all been caused by zoonotic viruses, meaning
they are transmitted from animals to people.
detect infection from emergent viruses is very urgently needed.
About Us
Who we are
Research & Development
State-of-the-art R&D targeting testing solutions for the present and future needs of healthcare.
Quality Manufacturing
Quality control and quality assurance guaranteed. All components are manufactured under ISO-13485 certified protocols with superior risk mitigation protocols, supervision, and process oversight?
Global Impact
Professional distribution partners and healthcare professionals promoting meaningful and impactful solutions in each market where we are active globally.
Products
Testing to Prevent the Spread of COVID-19
Medical experts have stated repeatedly that frequent testing with affordable, and reliable SARS CoV 2 rapid antigen diagnostic tests, when implemented simultaneously with an aggressive vaccination rollout and appropriate masking, is the most effective integrated strategy to mitigate the transmission and spread of this virus.
A Ready, Willing, and Able Team
The BioSynchronicity team is ready, willing, and able to provide reliable, affordable, and highly accurate in vitro diagnostic tests to clients globally.
We have completed warehousing and packing arrangements in the USA market from our hub in Rochester, NY, and will be servicing the European market from facilities in The Netherlands. The MENA and African markets will be serviced from Ras Al Khaimah in the UAE.
Our goal is to keep our communities safe and prevent the spread of infections. In order to do this we have organized our team to have current commercial scale production capacity to manufacture up to 2 million test kits per week. With current supply chain allocations, we are able to ramp up manufacturing capacity to 1,000,000 test kits per day in case of rising positivity rates and the onset of a new wave of infections. Our flagship tests are for Professional Use at the Point of Care (POC). Our tests are packaged in boxes containing 20 tests per box and 40 boxes per master shipping carton.
01.
Manufacturing
Components are manufactured under strict supervision and quality control/assurance protocols. Good workmanship is guaranteed in every step of the manufacturing process.
02.
Packaging
Packaging will be done under continuously monitored temperature & humidity controls and adapted to customer’s needs. Packaging can be customized in appropriate languages and include symbols or certification required by local regulatory bodies.
03.
Quality Control
We ensure test cassette manufacturing is fully automated, with high-quality robotic systems under strict ISO certified protocols.
04.
Performance Testing
Testing was conducted by a respected Lab in Rockville MD, whose CEO is the immediate past President of the Washington Academy of Science. Clinical testing was conducted under strict FDA protocols at Ochsner Health in New Orleans and corroborated by both the Ochsner Health Lab as well as by Louisiana State University (LSU).
Certification
The BioSynchronicity C-Sync™ COVID-19 Antigen Test received its FDA Emergency Use Authorization (EUA) on March 23, 2023. The EUA letter of authorization from the FDA allows us to conduct sales in the United States at the point of care.
We have also achieved the CE Mark certification for the European Union and have registered in the European Union with the Ministry of Health of The Netherlands. Local certification requires about 2 to 4 weeks in the other jurisdictions, but only once a distributor is identified and appointed. Additional countries in MENA and Africa recognize the authority of the CE certification and allow us to start selling now. A Free Sales Certificate has been successfully issued for the UAE and validated by the UAE Embassy in The Netherlands.
We are able to sell products throughout the USA, Europe, MENA and Africa.”
CE Certification
FDA EUA (EUA220346)