The Clarifi autism saliva test is officially available for health care providers to order in the United States.

This diagnostic aid is available to children 18 months through 6 years old, and can help provide parents and clinicians with more confidence to diagnose a child with autism. That in turn, can start early intervention services sooner, rather than putting them on a waiting list. It can also be used to help determine the urgency of a specialist referral. 

(Interested in getting the test? Learn if your child is eligible here). 

As this new type of next-generation sequencing technology develops, many people are wondering: What happens with the collected biospecimen

Clarifi ASD is HIPAA Compliant

Our company, Quadrant Biosciences, has worked hard to make sure every step of the Clarifi process is HIPAA compliant. But what does that really mean?

HIPAA stands for the Health Insurance Portability and Accountability Act. This was created in 1996 primarily to ensure that your Protected Health Information (PHI), like your full name or date of birth, is protected when you give it to healthcare professionals and insurance companies. You can take a deeper dive here

If an organization is HIPAA Compliant, it means they must have a network that can properly handle and safeguard your protected health information. Digital Guardian explains it well: 

The Health Insurance Portability and Accountability Act (HIPAA) sets the standard for sensitive patient data protection. Companies that deal with protected health information (PHI) must have physical, network, and process security measures in place and follow them to ensure HIPAA Compliance. Covered entities (anyone providing treatment, payment, and operations in healthcare) and business associates (anyone who has access to patient information and provides support in treatment, payment, or operations) must meet HIPAA Compliance. Other entities, such as subcontractors and any other related business associates must also be in compliance.”

In the wake of the rising popularity of genetic testing, it’s important that companies set these regulations to protect their patients’ data from potential threats, like hackers or third-party buyers.

At Quadrant Biosciences, we have taken every precaution to ensure HIPAA Compliance.

Clarifi ASD is Not a Genetic Test

Unlike other new tests you may have heard about, Clarifi ASD is not a genetic test but an epigenetic test. Genetics is the study of our underlying genes. Epigenetics is the study of how our genes express themselves. 

When a child is swabbed using Clarifi ASD, we are collecting and analyzing RNA and microbial content in the saliva, including miRNA and piRNA—not DNA.

HIPAA compliance

Patient Data is Secure

Finally, any collected patient data is stored in a secure Amazon Web Services (AWS) cloud. This is the world’s most comprehensive cloud platform and is used by millions of customers to protect sensitive information. 

According to Amazon, AWS is the most flexible and secure cloud computing environment available today. “Our core infrastructure is built to satisfy the security requirements for the military, global banks, and other high-sensitivity organizations. This is backed by a deep set of cloud security tools, with 230 security, compliance, and governance services and features.” 

In short, patient data that goes into the cloud remains secure. Quadrant Biosciences does not sell or share any protected health data to any third party.

How to Get the Clarifi Autism Saliva Test

Knowing that the Clarifi test results are accurate, research-backed and privacy protected is important to you and it’s important to us. That is why we have taken steps to ensure those needs are met. 

If you think Clarifi ASD would be the right next step for your child, please visit ClarifiASD.com/get-clarifi to learn more. Clarifi ASD does have to be ordered and administered by a health care provider. 

If your child’s doctor hasn’t heard about this relatively new test just yet, no worries! We’ve created a PDF that you can share with them to help introduce the test. Or, if you would prefer, you can send us their information and we’ll have a member of the Clarifi Team reach out on your behalf. Just fill out the simple form on ClarifiASD.com/get-clarifi

If you have any questions, don’t hesitate to reach out! Send us an email at info@ClarifiASD.com