About Us
Our Mission
SalivaDirect, Inc. is a nonprofit dedicated to enhancing public health through accessible testing strategies, developing and deploying innovative solutions that respond to evolving global health challenges. By providing equitable testing, we aim to advocate, promote, and advance diagnostic solutions.
Our Vision
SalivaDirect, Inc. manages and supports a designated lab network where saliva-based protocols provide equitable testing options for communities. We aim to advance the research and development of new assays and to deploy these strategies in pursuit of health equity.
Our History
In 2020, the SalivaDirect™ protocol was developed by researchers at the Yale School of Public Health in response to the COVID-19 pandemic. While nasal swabs became the gold-standard diagnostic sample type, supply-chains buckled under the demand for swabs and reagents, healthcare workers were put at risk having to obtain samples, and patients avoided testing due to the discomfort of the standard method. SalivaDirect™ was born out of these conditions, designed to aid communities and labs in establishing affordable and equitable SARS-CoV-2 testing programs that leverage existing resources and improve patient experience.
Due to the flexibility and low-cost of SalivaDirect™, more than 200 laboratories across 42 U.S. states have provided over 6.5 million tests. SalivaDirect™ was used in testing programs across the country to keep K-12 schools, universities, workplaces, and even the National Basketball Association (NBA®) open and safe as we returned to a new sense of normalcy. With disparities in access to testing persisting to this day, we continue to develop innovative programming and projects that bring testing to those who are often left behind by the U.S. healthcare system.
To better support an expanded scope of work, we spun out from Yale University in 2022 into an independent 501(c)3 organization: SalivaDirect, Inc. (SDI). SDI is a nonprofit that works to develop and deploy diagnostic testing strategies in response to global health challenges. We continue to expand our assay portfolio and deliver innovative testing solutions.
Since 2020, we have:
Delivered more than 1400 tests to over 120 community events through our “lab-in-a-van” partnership with Yale Pathology Labs.
Piloted a vending machine model to deliver test kits throughout rural Oregon in collaboration with Santiam Hospital.
Provided tests during the humanitarian crisis in partnership with Integrated Refugee and Immigration Services (IRIS) to 100+ Afghan refugees relocating to New Haven, CT.
Trained laboratory scientists at the Malawi Liverpool Wellcome Trust to use our SalivaDirect™ protocol to test for respiratory viruses.
Hosted over 50 paid internships for undergraduate and graduate students, training the next generation of public health and diagnostics professionals.
Our team is currently working on SalivaDirect+™, our first offering in low-cost panel testing. With the development of SalivaDirect+™, the scope of our saliva-based test will expand to include SARS-CoV-2, Influenza A, Influenza B, and Respiratory Syncytial Virus (RSV) – all detectable from a single saliva sample. Stay tuned for updates.
Meet
the Team
Yasmine joined the SalivaDirect, Inc. team in 2021 as the Business and Strategy Manager and became Executive Director in 2023. She provides strategic leadership, oversees operations, and fosters partnerships, ensuring that SDI’s mission and goals are achieved through effective team management.
Email: [email protected]
Yasmine Ali
Executive Director
Alex joined the SalivaDirect, Inc. team in 2024 as the Director of Science. She leads the design and execution of clinical studies for FDA regulatory submissions and oversees laboratory assay development. Additionally, Alex drives innovation initiatives, fosters scientific partnerships, and secures funding to support groundbreaking research and development projects.
Email: [email protected]
Alexandra Kitz
Director of Science
Laura joined the SalivaDirect, Inc. team in 2023 as the Regulatory Compliance Manager. She and her team manage the laboratory network and the associated Quality Management System (QMS) data. Laura oversees the QMS, ensures regulatory compliance, and submits new filings to the FDA.
Email: [email protected]
Laura Burke
Regulatory Compliance Manager
Brittany joined the SalivaDirect, Inc. team in 2021. As the Director of Programs, she oversees our expanding portfolio of initiatives, which includes managing SDI’s progressive public health solutions implemented in the field. Brittany utilizes her stakeholder engagement and operations expertise to build partnerships that further SDI’s mission and enhance our impact in underserved communities.
Email: [email protected]
Brittany Choate
Director of Programs
Russell joined the SalivaDirect, Inc. team in 2021 as an Intern while enrolled at the Yale School of Public Health. After earning their Master of Public Health (MPH) degree, Russell transitioned to a full-time position as a Senior Business Development Associate in 2023. Their responsibilities include supporting fundraising efforts, managing grants, contributing to strategic planning, and serves as a liaison to SDI’s Board of Directors.
Email: [email protected]
Russell Thomas
Senior Business Development Associate
Victoria joined the SalivaDirect, Inc. team in 2024 as the Marketing Manager. She specializes in go-to-market strategy and digital media. Her responsibilities include implementing our marketing strategies to enhance SDI’s programs and increase brand visibility. Additionally, she oversees all advertising communications, handles media inquiries, and manages event information.
Email: [email protected]
Victoria Hurley
Marketing Manager
Tasha joined the SalivaDirect, Inc. team in 2022 as a Fractional CHRO. She oversees all aspects of human resources, including talent management, operations, and employee benefits. She is responsible for developing all of SDI’s HR policies and strategies, as well as leading the company’s learning and development initiatives.
Email: [email protected]
Tasha Kitty
CHRO Consultant/ Human Resources
Jazmin joined the SalivaDirect, Inc. team in 2024 as an Executive Assistant. She is responsible for managing various administrative needs, ensuring seamless coordination of schedules, and supporting key executives. Jazmin plays a critical role in streamlining communication and maintaining organizational efficiency.
Email: [email protected]
Jazmin Steir
Executive Assistant/ Admin
Shyam Saladi - Neelyx Labs
Prem Premsrirut - Mirimus
Robby Sikka - SMART
Lolahon Kadiri - Yale Ventures
Meet the SDI Board
Anne Wyllie
Pfizer
Avi Robbins
Porex Life Sciences Institute
Shyam Saladi
Neelyx Labs
Prem Premsrirut
Mirimus Inc
Robby Sikka
SMART
Lolahon Kadiri
Yale Ventures
Testimonials
What People Are Saying
Where can I find the SalivaDirect™ protocol?
The protocol is publicly available here. Please note that in order to offer the SalivaDirect™ test, the laboratory is required to be designated by SalivaDirect, Inc. and receive the complete Instructions For Use (IFU).
How can my lab get designated to use SalivaDirect™?
The designation process is available here.
How does saliva compare to other sample types (nasopharyngeal swab, nasal swab, etc.) in terms of sensitivity and specificity for SARS-CoV-2?
SalivaDirect™ has been validated and shown to perform as well as other sample types (see publications here). In addition, the limit of detection as determined by blinded standards, as set by the FDA, shows that the sensitivity of SalivaDirect™ is comparable to many other PCR tests – including those with RNA extraction.
Where can I find the list of equipment validated for SalivaDirect™?
The current list of validated equipment for SalivaDirect™ can be found here.
Can other fluorophores/PCR kits/proteinase K be used instead of what is listed on the EUA?
SalivaDirect™ can only be run with the validated reagents and equipment listed on our EUA. However, we validated multiple reagents and platforms in an effort to circumvent any supply chain issues, as well as help keep prices down through competition between suppliers.
What if we don’t have one of the PCR platforms listed on the EUA? Do we have to buy all new PCRs?
Our mission with SalivaDirect™ was to help labs easily implement saliva testing. By including a variety of PCR instruments in our EUA, we hoped that most labs would be able to utilize existing platforms and avoid the expense of purchasing additional equipment.
Can frozen specimens that are thawed be used for validation?
Yes.
Does a second RT-qPCR (if needed) work from a frozen sample?
Yes, we have had success with retesting either frozen saliva samples or the prepared lysate after a couple of freeze/thaw cycles.
Can the PCR systems listed on the EUA also be used for the heat inactivation step?
Yes.
We currently have a class II type A2 biosafety cabinet - is this sufficient for processing samples for this protocol?
Before implementing SalivaDirect™, you should consult with your CLIA director, local EHS, and/or local state health department to confirm the safest way to conduct SARS-CoV-2 testing and carry out the SalivaDirect™ protocol in your lab.
How long does it take to test samples using SalivaDirect™?
Results can be reported in under two hours. The actual time will vary between labs as differences in workflow, sample volume, data reporting, and other factors will affect how long it takes to complete the protocol.
Are the protocols for the 96- and 384-well format PCRs different?
While the cycling conditions are the same, the 384-well format requires a smaller reaction volume, so is indeed different to that detailed for the 96-well format.
Can SalivaDirect™ be used with automation to help increase sample throughput?
Yes, SalivaDirect™ can be used with automation to help increase sample throughput. Our EUA includes both manual processes as well as automation equipment, allowing flexibility in how the test is performed. Any automation equipment or processes listed within the EUA can be used to streamline the workflow and enhance efficiency.
What data does our lab need to submit to SalivaDirect, Inc. to join the network?
What is the difference between "SalivaDirect, Inc." and "SalivaDirect™"?
SalivaDirect, Inc. refers to our company as an organization, whereas SalivaDirect™ is the protocol.
What is the SalivaDirect™ test?
SalivaDirect™ was developed at the Yale School of Public Health to test persons suspected of having COVID-19 for the virus, SARS-CoV-2. It is ideal for large-scale testing and offers a number of advantages over traditional testing methods. SalivaDirect™ received emergency use authorization (EUA) from the U.S. Food and Drug Administration on Aug. 15, 2020.
Can I buy a SalivaDirect™ kit through your website to test myself or my family?
SalivaDirect, Inc. does not provide testing or testing kits. Please visit our lab directory for assistance in locating and scheduling SalivaDirect™ testing in your area.
Where can I get tested?
We have a network of laboratories authorized to administer the SalivaDirect™ test. Please visit our lab directory to find a participating lab near you.
Can schools get their students tested with SalivaDirect™? How about other organizations?
Yes, SalivaDirect™ can be used for patients two (2) years and older. We suggest reaching out to a designated laboratory to discuss options for implementing a SalivaDirect™ testing program. If there is not a designated lab in your area, high-complexity CLIA labs can apply for designation.
I am an employer and wish to test my employees. How can I use SalivaDirect™?
We suggest reaching out to a designated laboratory to discuss options for implementing a SalivaDirect™ testing program. If there is not a designated lab in your area, high-complexity CLIA labs can apply for designation.
How much does a SalivaDirect™ test cost?
Our mission with SalivaDirect™ was to drive down testing costs and help make testing more accessible around the country.* However, the exact price a lab may charge for a single SalivaDirect™ test depends on a number of factors, including costs for their facilities, staff, instrumentation, and the logistics required for test collection and result delivery.
*SalivaDirect™ essentially operates as a diagnostic industry equivalent to a “generic” diagnostic test. With our flexible model, labs can mix-and-match the instruments and reagents they use, allowing them to run the test at an extremely low-cost: only $2-5 per sample (minus overhead).
How is SalivaDirect ™ different from other testing methods?
In addition to being less expensive, SalivaDirect™ offers a number of other advantages.
- It is non-invasive. SalivaDirect™ requires only a small sample of saliva as opposed to the standard nasopharyngeal (NP) swab. The NP method requires what is essentially a long Q-tip that is inserted deep into the nostril and then rotated.
- Results show that SalivaDirect™ is quick, accurate, reduces risk, and is comparable to other NP-based tests. Because SalivaDirect™ only requires a small saliva sample, it typically takes less than a minute for an individual to drool into a collection device. It is also safer for healthcare workers as the procedure reduces risk of exposure. The limit of detection determined by blinded standards sent out by the FDA shows that the sensitivity of SalivaDirect™ is comparable to many other PCR tests out there – including those with RNA extraction.
My lab is also working on COVID-19 testing. Can we use the SalivaDirect™ test?
Potentially, yes. If your lab is a high-complexity CLIA certified laboratory and located within the United States it can request designation to implement SalivaDirect™ under our EUA by filling out an application form here.
How will SalivaDirect ™ evolve for the future?
SalivaDirect, Inc. is in the process of adding laboratories to our network to expand accessibility. We are also launching clinical trials to detect new targets. Subscribe to our newsletter for the latest updates.
Is an at-home saliva collection kit available?
SalivaDirect, Inc. does not have any at-home saliva collection kits at this time.
How can we become a distributor of SalivaDirect™?
SalivaDirect™ is a protocol performed by CLIA labs in the SalivaDirect™ network. If you are a CLIA certified laboratory, visit our Clinical Labs page.
What is the SalivaDirect™ Authorized Laboratory Agreement?
The Authorized Laboratory Agreement is the contract between SalivaDirect, Inc. and approved CLIA laboratories granting the laboratory access to the SalivaDirect Designated Laboratory Network and authorizing them to perform the SalivaDirect™ test under the EUA.
Why is there a confidentiality clause in the Authorized Laboratory Agreement?
The SalivaDirect™ Instructions for Use (the “IFU”) document is the “product” authorized by the FDA for emergency use and can be shared only with laboratories designated as authorized laboratories by SalivaDirect, Inc. Per terms of the EUA 202097 and the Authorized Laboratory Agreement, the designated laboratories must not share the IFU with anyone outside of their own laboratories or publicly post or display the IFU.
Our laboratory has multiple sites, does each site need to have a separate designation?
The SalivaDirect, Inc. Designated Lab Network requires one (1) Authorized Laboratory Network Agreement per CLIA number.
