What is a precision health testing platform?

Since precision medicine was introduced, we have seen a strong increasing trend in the past 10 years, from the one-size-fits-all to individualized action plans. In other words, the same treatments or therapeutics were prescribed previously to all patients, but the industry is moving to the new treatment model where each individual would be treated based on their genomic signatures or biomarkers. This is not only happening in medicine, but also in wellness, nutrition, and fitness.

All of these precision modalities have one thing in common, which is a new layer called Precision Health Testing. This can be companion diagnostics, genetics, microbiome, or any other biomarker test. In order to launch a Precision Health test, you need a Precision Health Testing Platform.

 

Precision Health testing platform

Now let’s take a look at what Precision Health testing platform is:

Precision Health testing is a platform that combines 6 different building blocks, such as:

• Lab 
• Customer relationship management (CRM)
• Cloud
• Scientific algorithms
• Physician/science
• patient portal and patient experience

 

 

All six components need to be integrated and in place to offer Precision Health solutions. Each component has several responsibilities that are highlighted in the table below.

The common challenges when delivering precision health testing

Delivering precision health tests to physicians and patients is not straightforward, and there are several challenges, such as:

1. It cost health organizations and consumer companies somewhere between one to two million dollars in software development.
2. It takes organizations anywhere between eight months to two years before the platform is fully operational.
3. Before the product goes live, security guidelines and regulatory barriers such as HIPAA, SOC2, GDPR, CLIA, have to be fully implemented.
4. Physicians’ and patients’ experience with these products is not well thought of and lacks quality. The reason behind poor user experience is not because of bad engineering but is related to the fact that these products are launched as version 1. Even Google and Facebook platforms had a bad-quality first version and needed a lot of improvements before they were globally adopted.

What’s interesting is that this process is totally undifferentiated, and all of this platform development is not part of the core competency of these companies and organizations.

 

How ixlayer changes the Precision Health testing process

ixLayer is a first-of-its-kind Precision Health solutions platform. A fully HIPAA-compliant Cloud platform that integrates with all of the needed services to launch on Health products for precision health tests.

ixLayer precision care software benefits:

• It enables physician oversight on approving and delivering health tests & providing diagnostic health solutions.
• It is integrated into the clinical labs’ information management system (LIMS).
• It enables the delivery of genetic or pharmaceutical counseling to patients.
• It enables health organizations to engage physicians through electronic health records (EHR).
• It is integrated into the interpretation services.
• It enables e-commerce for out-of-pocket payments as well as insurance reimbursement. 

 

 

Basically, this is everything needed to launch a Precision Health Test or a genetic product. ixLayer precision health care platform enables enterprises to launch Precision Health tests within weeks at a fraction of their own cost with the best-in-class quality from user experience to security, and scalability.

 

What are the different types of health tests?

The precision health testing landscape can be divided into three different segments, such as:

1. Physician-ordered test. Historically, precision health evaluation has been dominated by a clinician-centric model in which a patient’s physician had the central responsibility for ordering the test and communicating the results. This paradigm is done for clinical health tests that can range between a simple use for an annual check-up to a genetic carrier screening test. Examples of laboratories doing these tests are LabCorp, Quest Diagnostics, Guardant Health, and Invitae.
2. Patient-initiated testing. In this emerging paradigm, the patient goes online to order a precision health test in a web portal.  These clinical health tests are also known as lab-developed tests (LDT) and don’t need FDA approval, but the labs performing the tests are regulated by clinical laboratory improvement amendments (CLIA). In this model, there is a need for a physician’s approval sign-off on the results in order to deliver them to patients. Some examples of these types of tests are Mayo Clinic, Color Genomics, Everlywell , or let’s get checked.
3. Direct-to-consumer precision health testing (DTC): In this model, the consumers are empowered because they can order their own tests online without any physician involvement, obtain the samples by using home test kits, and receive the results directly from the laboratory or company that provides the tests. Wellness, fitness, nutrition, and ancestry fall into this bucket category of precision health tests from companies like 23andMe (www.23andme.com), Ancestry (www.ancestry.com), or DNAfit (https://www.dnafit.com/).

 

 

The ixLayer platform is set up to support all these types of tests (physician-ordered, patient-initiated, and direct-to-consumer) as following:

– it integrates with the electronic health records to support test ordering by the physicians, 

– it integrates with third-party physician networks, in all 50 states, to support patient-initiated testing,

– it integrates into any lab or lab management system for supporting direct-to-consumer genetic testing.

 

Patient-Centered precision health testing process flow on ixLayer platform

The diagram below demonstrates the user, sample, and data flow for a precision health test from the time a patient initiates a test until the result is delivered.

 

Now, let’s take a closer look at the steps involved in Precision Health testing:

Step 1 – Education and ordering:

Education 

A patient is guided to your website through different marketing channels. The patient gets all the information he needs about the health test and can directly order the test online.   

Ordering

Patients have three possibilities to order the test:

1. Out-of-pocket – the payment is made through 3rd party e-commerce platforms,
2. Insurer pay – the payment is made through reimbursement services, 
3. Sponsored – the payment is made through government organizations or Biopharma.

Step 2 – Intake process and physician approval:

Once the patient has ordered a product, he is guided to an onboarding process which involves:

•  account registration,
•  electronic consent,
•  intake health questionnaire.

 

These steps are fully customizable based on each test and client’s needs. The patient’s data is securely stored in a HIPAA-compliant cloud.

The Health Data is shared with:

– a physician through EHR, 

– a Physician Network through API integration,

– or the approval of the patient initiates the tests.

A physician reviews the intake assessment and approves the test for the patient, and then the approval is sent back to ixLayer by API or EHR (FHIR, HL7).

Because of different reasons, there will be some cases where the physician might not approve the test, but at that point, ixLayer will immediately reimburse the user or the patient.

Physician approvals are not needed for Direct-to-consumer genetic products in wellness, fitness, or nutrition.

 

Step 3 – Sample collection:

If the test is approved for the patient, ixLayer will send the order through the API Notifier fulfillment center, which will send out a sample collection kit to the patient. The fulfillment center will inform ixlayer with tracking info. The sample collection tube (e.g. for saliva), the sample collection box, and the shipping method are all customizable based on the client’s need.

 

 

The patient will receive the sample collection box in the comfort of his home, then he will collect the (saliva) sample, and then he will put the sample collection box into the mail for it to be sent to the selected lab. The ixLayer – digital healthcare solutions platform it’s integrated with the selected laboratory and will notify it about the sample collection box that is coming their way.

 

Step 4 – Lab process:

The laboratory receives the sample collection box and starts its process, whether is genotyping, sequencing, or any other type of biomarker procedure. This process can take anywhere between two to 6 weeks. ixLayer will receive notifications from the lab, through API integration, about each change that occurred in the sample status, and can inform the patient about the status of his sample in the Patient Portal.

 

 

Once the lab has completed its process, the data is securely sent through an encrypted channel to ixLayer. The ixLayer platform supports all data types from the whole genome, exome, targeted sequencing panels, and SNP microarrays.  It also supports different file formats such as fastq VCF or can be interpreted as a result in PDF or JSON.

 

Step 5 – Generating the result:

There are three options for generating the report or the result for the patient:

• First option – The Physician or Physician Network can have the results in a PDF format directly from the lab through ixLayer.
• The second option – the lab sends the raw data to ixLayer;  ixLayer will host your interpretation algorithms (imputation, interpretation, annotation, polygenic risk score, and more) and run the data to your algorithm to produce the results or a report for the patients. The algorithms are stored in a Docker software container. ixLayer team can also help you to convert some of your scientific discoveries if needed.
• The third option uses external interpretation services, whether it is third-party services or your own services, on a different server or Cloud.  In that case, ixLayer will send, through secure API transfer, the data to the interpretation service, and receive and interpret the results for the patients. 

 

 Step 6 – Physician signs of:

When the result is generated for patient-initiated and physician-ordered tests, the result is forwarded to the physician or Physician Network. Based on the decisions made by the physician, the results can be shown immediately to the patient in their Patients’ Portal or if a genetic counseling session is needed, ixLayer is allowed to show the result of the patient in their portal. The physician will sign off the result or will request the patient to consult with a genetic counselor before releasing the result. A patient can ask for a genetic counseling session at any time pre or post results and book a session directly through the Patients’ Portal.

 

 

As you can see from the steps above, a Precision Health testing platform involves:

• The communication between different services and the patient (basically a Healthcare CRM).
• Integration with the lab and interpretation services. 
• Storing data security in a Cloud server.  
• Running bioinformatics and interpretation algorithms in the Cloud server.
• Physician oversight, the weather is through third-party physicians or primary care physicians.
• Interacting with the patient through the user-friendly Patient Portal.

All of these building blocks are in place for you so you can launch your Precision Health within a matter of weeks.

 

A completed back-end process which enables a seamless patient experience

The flow diagram from a patient’s point of view is very seamless and trivia. All of the hard work has gone into making the patient’s journey with ixLayer as easy as possible. The patient does not see or experience all of the complicated steps explained in the previous sections. Below are 5 simple user-friendly steps for the patient: 

 

1. The patient is directed to an information website.
2. The patient takes a health intake assessment.
3. The patient follows the instructions for sample collection. (Blood, saliva, DNA-source, tissue, etc.)
4. The patient gets the result in a HIPAA secure portal.
5. The patient can easily book a genetic counseling session online at any time.

 

We want to complete this article by quickly introducing you to one of the ixLayer clients and give you the possibility to explore the Patient Portal and a Precision Health test for yourself.

 

Meet one of the ixLayer customers – ADxHealthcare

ADxHealthcare (adxhealthcare.com) is one of the companies that launched their product on ixLayer. Below is their APOE Alzheimer’s product including custom storefront Marketplace, Patient portal, Physician portal, and payment handling for Web & Mobile.

 

Use the following credential to log in to the Patient Portal and experience the product demonstration:

https://genetics.adxhealthcare.com 

UserName: demo@ixLayer.com

Password: User123!