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.
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:
All six components need to be integrated and in place to offer a Precision Health test. Each component has several responsibilities that are highlighted in the table below.
Delivering precision health tests to physicians and patients is not straightforward, and there are several challenges, such as:
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.
ixLayer is a first-of-its-kind Precision Health testing 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 health testing platform benefits:
Basically, this is everything needed to launch a Precision Health Test or a genetic product. ixLayer 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.
The precision health testing landscape can be divided into three different segments, such as:
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.
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:
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.
Patients have three possibilities to order the test:
Once the patient has ordered a product, he is guided to an onboarding process which involves:
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.
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 platform it’s integrated with the selected laboratory and will notify it about the sample collection box that is coming their way.
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.
There are three options for generating the report or the result for the patient:
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:
All of these building blocks are in place for you so you can launch your Precision Health within a matter of weeks.
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:
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.
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:
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