Manufacturing Services


Conversion of lab-based assays into lateral flow equipment for use at the Point Of Care (POC)

In vitro diagnostics – Clinical Research Consulting

 

Johnson & Johnson Co. (CYPHER stent by Cordis): World’s First Drug-eluting stent

 

Pfizer, Inc: (GUARD – ANGIOGUARD): Saphenous Vein Graft Intervention

 

North American Diagnostics, LLC: OEM SARS-CoV-2 Rapid Antigen Test 

Adaptation for Use in Extreme Conditions 

Adaptation for Use in Tropical Environments

North American Diagnostics, NAD was born out of the vast experience accomplished in the world of science since 1990, a span of three decades. We  attribute our success in Research and Development to the world class, guidance and leading-edge experiences acquired as scientists at Pfizer, Inc working exclusively on Pfizer’s premiere pipeline of biologics and devices in clinical research.

This experience laid a solid foundation for us to eventually consult in research and development for clients, viz. Pfizer, Novartis, Johnson & Johnson, Biogen, Glaxo-Wellcome, Boehringer Manheim, Sandoz, Ciba, Bristol Myers Squibb, Amgen and Cyberonics, within Multi-Disciplinary Specialties including Oncology, Neurological, Musculoskeletal, Infectious Disease, Cardiovascular, Endocrine; Biologics & Device; phases 1 to 4.

Within the US Nutraceutical arena, the team focuses heavily on extraction and formulation of Hemp based products (oral, dermal & food) becoming a specialist and extraction formalist, manufacturing for national brands. This has led to formulation and development of novel Keto Weight Loss supplements and .

The experiences from weight loss led to resarch in Diabetes type II and the cross over in Covid-19 with future  development of  clinical trial-based, plant based, products analyzing biological markers beyond HbA1c and other older standards

North American Diagnostics, a leading edge POC LFI Manufacturer, made a natural and organic transition to the point-of-care lateral flow device manufacturing arena by amplifying core specialties.

Our POC Lateral Flow cassette kit manufacturing in the USA possesses strong “on-demand” overseas load-balancing. 

We are a respected and proven POC lateral flow assay manufacturer based in the United States, USA, offering lateral flow assay ODM contract-manufacturing services, including OEM (original equipment manufacturing) and ODM (original design manufacturing). Now with over thirty years of experience in a highly regulated R&D, and contract manufacturing. Lateral flow device point of care, POC development, testing, tuning, and consistent production, ensures that we are able to deliver the finest quality, ethical,  and efficient OEM and ODM products from your American partner located in Daytona Beach, Florida, USA.

  • Conversion of lab-based assays (e.g. ELISA) into lateral flow equipment for use at the Point Of Care (POC)
  • Assisting clients with initial beta testing and viability to high-volume commercial production.
  • Collaborative minor design to full bore inception and implementation so you can take over from where you feel most comfortable.
  • If you have a POC Rapid Device and would like to improve the assay or reagent, North American Diagnostics can assist with lamination improvements, poly or monoclonal antibody edits. 
  • Qualitative lateral flow Immunoassay test kits
  • Semi-quantitative lateral flow assay tests
  • Quantitative lateral flow rapid diagnostic kit evaluation
  • Addition of readers to extend the life cycle of your existing lateral flow model
  • Cassette/Strip reading device services
  • Point-of-care services for our ODM and OEM clients

LAUNCH CAPACITY

For our select clients, we have made a commitment to be able to go from zero to 5 million sku’s within the same 30 days as the initial launch date.

SPIKE CAPACITY

For our select clients, we have made a commitment to be able to go from zero to 5 million sku’s within the same 30 days as the initial launch date.

Aggregate production of 18 million units, single-sku items monthly.

Month 3: 18 million units per month

Month 6: 36 million units per month

Month 12: 72 million units per month

GLOBAL CAPACITY

For Q1 2022, we will have completed and beta tested our ability to produce 250 million units per monthly output with our purpose-built expanded tri-continent manufacturing system.

ODIP “on-demand & in-place” is a vetted with prototypes, master contract system with friendly partner ISO manufacturing sites to be able to produce up to an aggregated 250,000,000 mono-nitrocellulose lateral flow assays on a monthly basis. To accomplish this, the expansion lead time is spread over 4 months.

Our LFA’s have been awarded CE Marking for Medical Device Certification which authorizes  sales and distribution in 31 countries in the European Union.

Paul currently leads a skilled team of scientists, manufacturing and administrative work force from the  North American Diagnostics manufacturing plant in Daytona Beach, Florida, a truly American based organization producing made in America products.

Producing the World’ Most Accurate & Durable POC assays (IVDs) to enable unrestricted use outside of climate controlled facilities, particularly in limited resource settings is North American Diagnostics’ mantra. We enjoy building durable, accurate, resilient, robust and scalable lateral flow immunoassay (LFIA) based rapid diagnostic tests (RDTs) at affordable pricing to truly open and equitize global healthcare access. North American Diagnostics’ has created an affordable, and sustainable test platform for all health systems globally – quality products to battle not only COVID-19, but many serious diseases.

Zambia became an entrance into making a global impact into the lives of “regular peope” . Its a true blessing which occurred organically and by-chance. Zambia, is truly about “one zambia, one nation” which North American Diagnostics extends to “One Zambia – One World – One- Love”

Currently, North American Diagnostics is focusing on the submission of an OEM  SARS-CoV-2 POC Rapid Test for HCP and OTC global markets with the FDA, WHO and ZAMRA. Clinical trials of the company’s plant based Diabetic medications is also currently in process.

Elizabeth Lashinsky