Molecular Diagnostics Development

Authenticated controls that support each stage of your diagnostic development process

Molecular diagnostic assays are powerful tools for the rapid detection and identification of clinically relevant pathogens. That's why it is essential that they are properly validated to ensure accurate results and uncompromised data.

As your end-to-end partner for the development and control of diagnostic assays, ATCC supports each stage of your workflow by providing authenticated live strains, quantitative molecular standards, and next-generation sequencing standards. Explore our resources below to see how we can collaborate on your next assay.

Find solutions for each stage of your workflow

Round, floating, purple-blue balls of staphylococcus aureus bacteria.

Live cultures

ATCC provides a vast array of authenticated, high-quality microbial strains with clinical relevance in infectious disease.

Explore microbial strains

Molecular standards

Explore our ready-to-use quantitative genomic and synthetic DNA and RNA for infectious disease research and assay development.

Explore our portfolio

NGS standards

Optimize your diverse research applications with confidence and improve the consistency and reproducibility of your data.

Explore NGS standards

ATCC products for respiratory diagnostics development

Explore assay development resources for infectious diseases

SARS-CoV-2 molecular diagnostics development

For SARS-CoV-2 molecular diagnostics manufacturers moving from emergency use authorization (EUA) to 510(k) premarket submission to the US Food & Drug Administration (FDA), robust testing must be performed to demonstrate that the device is safe and effective as well as substantially equivalent to legally marketed devices. To support these validation studies, ATCC provides an extensive array of authenticated and clinically relevant strains and genomic and synthetic nucleic acids for evaluating limit of detection, inclusivity, and cross-reactivity.

Develop your SARS-CoV-2 Assay

Monkeypox virus molecular diagnostics development

Accurate and rapid diagnosis of mpox is critical for timely healthcare and tracking of transmission. To support the need for increased monitoring, ATCC provides a variety of orthopoxviruses and nucleic acids that support assay development and validation. We have also developed a research use only (RUO) quantitative synthetic monkeypox virus DNA preparation with a sequence design based on several published assays.

Develop your mpox assay

Blue-gray, rod-shaped Salmonella bacteria with appendages

Zoonotic diseases

At ATCC, it is our mission to support global health by providing researchers with the resources needed to prevent, detect, and respond to infectious disease outbreaks. We will partner with the global research community to acquire, authenticate, maintain, and distribute the materials needed to respond to emerging zoonotic diseases.

View all Zoonotic Pathogens

Iridescent purple sphere of the influenza virus with protruding knobby spikes

Respiratory diseases

Respiratory pathogens that emerged from animal reservoirs such as SARS-CoV-2, MERS-CoV, SARS-CoV, and Influenza A virus (H1N1) have resulted in significant outbreaks that have led to numerous fatalities. To support critical research on these pathogens, ATCC provides authenticated strains, heat-inactivated materials, quantitative nucleic acids, and antibodies.

View all respiratory pathogens

Closeup of Culex tarsalis mosquito biting skin.

Vector-borne diseases

ATCC offers a wide range of microorganisms and nucleic acids that support research on prevalent vector-borne diseases such as Zika, chikungunya, West Nile fever, and Lyme disease. Our high-quality, authenticated reference materials are ideal for use in the development and evaluation of novel vaccines, innovative therapeutics, and rapid diagnostic tools.

View all vector-borne pathogens

Several pink, rod-shaped, furry Salmonella Typhi bacteria with long flowing tendrils.

Enteric diseases

Enteric diseases are often acquired through the consumption of contaminated food and water or contact with infected animals or fecal matter. To prevent the spread of disease, effective food testing and sanitation practices are needed. ATCC supports this area of research by providing a variety of authenticated microorganisms known to cause disease in humans.

View all enteric pathogens

Green, dumpling-shaped Trichomoniasis parasite with tails.

Sexually transmitted infections

Detecting and treating sexually transmitted infections can be challenging. ATCC can help! Our cultures and nucleic acids provide you with the reliability of fully authenticated reference materials for the development of novel therapeutics, vaccines, and rapid detection methods.

View all STI pathogens

Grainy, blue and orange Hepatitis virus.

Blood-borne diseases

The accurate detection and diagnosis of blood-borne disease is vital for ensuring proper treatment and preventing further transmission. Ensure the precision of your detection assays with authenticated strains and nucleic acids from ATCC.

View all blood-borne pathogens

View all infectious disease resources