Revolutionizing Healthcare with Convenient and Accurate At-Home Tests

About Our Labs and Science: Home Diagnostic Testing

At Healthyr, we’re dedicated to improving healthcare with developing cutting-edge technology that allows patients to perform diagnostic tests in the comfort of their own homes. People can now monitor their health more easily and conveniently than ever before.

Our research is driven by the belief that healthcare should be accessible and personalized for every individual. That’s why we’re committed to developing safe, easy-to-use testing solutions that can be taken by anyone, regardless of their location or circumstance.

The Science Behind the Test

What is Dried Blood Spot Testing?

Dried Blood Spot (DBS) Testing is a simple and effective way to check important health markers without the need for a blood draw or lab visit. This established technology has been in use since the 1960’s in areas such as neonatal care and for health testing in very remote locations. Healthyr has expanded this technology to test a wide range of health biomarkers, allowing you to check various aspects of your health from the comfort of your own home.

Our tests utilize an ADX card which contains a special type of paper that filters the blood solids from the blood plasma.
You collect your sample by pricking your finger with the provided lancet, and place a few drops of blood onto the card.
Once your sample is dry, you can mail it to the lab, where it will be reconstituted and tested on reliable central laboratory equipment. From there we can test for things like proteins, vitamins, minerals, hormones, and key indicators of organ and body system health.

Is DBS Testing reliable?

Multiple studies support the use of DBS and other self-collection methods for various biomarkers. The accuracy of DBS results is designed to work in a similar way to clinically-collected samples. The tests offered by Healthyr and those ordered in a physician’s office are comparable, and our partner labs’ testing methods and instruments go through a thorough validation process to ensure accuracy, precision, and clinical correlation. Before approving any of Healthyr’s tests, studies are conducted to ensure that the results from our DBS samples compare to traditional blood draw results within nationally-accepted limits of variation.

 About Our Labs

Our mission is to empower individuals to take control of their health by offering convenient, reliable, and accurate testing options. We do that by working with the most highly qualified laboratories in the country. Our team of experienced laboratory professionals follows strict safety protocols to ensure the accuracy and reliability of your test results. 

We hold ourselves accountable for:

Personal Protective Equipment (PPE)

Our laboratory personnel wear appropriate PPE such as gloves, lab coats, and eye protection to protect themselves from potential hazards like chemicals, biological agents, and radiation.

Chemical Safety

Our labs follow strict chemical safety protocols to ensure the safe handling, storage, and disposal of hazardous chemicals. This includes proper labeling, the use of appropriate containment and ventilation systems, and regular safety audits and inspections.

Biological Safety

Our labs follow strict biological safety protocols to ensure the safe handling and disposal of biological agents such as blood, tissue, and other specimens. This includes properly using biohazard containment systems, disposal of infectious waste, and regular safety training and inspections.

Equipment Safety

Our labs ensure that all laboratory equipment is properly maintained, calibrated, and validated to ensure accurate and reliable test results. This includes regular equipment inspections, and maintenance, as well as regular safety training for laboratory personnel.

Quality Control

Our labs follow rigorous quality control protocols to ensure the accuracy and reliability of test results. This includes regular internal and external quality control checks, participation in proficiency testing programs, and adherence to recognized standards such as CLIA and GLP.

Certifications, Safety Protocols, and Accreditations 

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The College of American Pathologists (CAP) is considered the gold standard in lab testing quality regulation in the United States. They use strict guidelines and standards to ensure that CAP-accredited labs maintain the accuracy of test results, ensure accurate patient diagnosis, meet or exceed standards for patient care and safety, stay up-to-date with changes in laboratory medicine and technological best practices, and work with laboratory staff to offer ongoing development and training. Their annual checklists for accreditation are compiled with input from over 500 certified pathologists to achieve the highest quality lab operations and laboratory inspections occur bi-annually to ensure compliance.

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CLIA stands for Clinical Laboratory Improvement Amendments. Their certification program regulates clinical laboratories in the United States to ensure that they are producing accurate and reliable test results.
The CLIA-Certification program sets national standards for laboratory testing quality and safety. Laboratories that perform testing on human specimens, such as blood, urine, or tissue, must meet certain requirements and pass inspections to receive and maintain their certification. 
The CLIA program applies to all types of laboratory testing, including tests performed in hospitals, clinics, physician offices, and research facilities. The program also requires laboratories to have trained personnel, quality control procedures, and appropriate record-keeping and reporting practices.

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Good Laboratory Practices

Good Laboratory Practices (GLP) is a set of guidelines that ensure the quality, reliability, and integrity of non-clinical laboratory studies in accordance with regulatory submission guidelines. GLP covers all aspects of laboratory testing, from the study design to the final report, to ensure that the data generated is of high quality and scientifically sound.

The main purpose of GLP is to ensure that laboratory studies are conducted in a consistent, reliable, and traceable manner. This includes things like maintaining accurate records, ensuring that instruments and equipment are properly calibrated and maintained, and providing appropriate training to laboratory personnel.

GLP applies to all non-clinical laboratory studies that are submitted to regulatory agencies, such as the US Food and Drug Administration (FDA), the Environmental Protection Agency (EPA), and the European Medicines Agency (EMA).

By following GLP, laboratories can ensure that the data generated from their studies are reliable and can be used to support regulatory submissions. This helps to ensure the safety and effectiveness of products that are marketed to the public, such as drugs, medical devices, and pesticides.

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High-Complexity Laboratory

A high-complexity laboratory has been evaluated and certified by an accrediting organization to meet certain quality standards for performing high-complexity testing. The term “high complexity” refers to the types of tests that are performed in the laboratory. These tests typically require a high degree of scientific and technical knowledge, as well as specialized equipment and procedures. High-complexity tests are used to diagnose and monitor complex diseases and conditions and guide treatment decisions.

Accreditation is a voluntary process in which a laboratory undergoes a comprehensive evaluation of its facilities, equipment, personnel, procedures, and quality control systems. Accrediting organizations, such as the College of American Pathologists (CAP) or the Clinical Laboratory Improvement Amendments (CLIA) program, review the laboratory’s performance against established standards and guidelines to determine if it meets the requirements for accreditation.
An accredited high-complexity laboratory demonstrates its commitment to quality and accuracy in performing high-complexity testing. This provides assurance to patients, healthcare providers, and regulatory agencies that the laboratory is capable of producing reliable and accurate test results. In addition, accreditation can improve the reputation and credibility of the laboratory and may be required for participation in certain healthcare programs or insurance networks.

Physician-Supported At-Home Testing for Better Health Management

Empowering You with Personalized Results Reviewed by Board-Certified Physicians

Physician Involvement

At Healthyr, we understand the importance of having real doctors involved in the testing process. That’s why we work with a network of independent board-certified physicians who review your lab requisition and approve eligible orders. They also review your final test results and offer consultation services for results that require significant action, such as a positive STI result. With Healthyr, you can feel confident that you’re getting reliable and accurate results that are interpreted by experienced medical professionals.

Easy-to-Understand Results

We believe that everyone deserves personalized information and education that empowers them to take control of their health. That’s why we offer a downloadable version of your results, in a format that your physician is used to seeing when reviewing lab results. This makes it easier for you to share your results with your doctor and ask any questions you have about your medical care.

Labwork Prescription

In many states, consumers are required to have a prescription from a board-certified medical doctor to order their own tests. At Healthyr, we work with a third-party independent network of physicians who provide authorization, review, and critical value consultation services for our customers related to their tests. Once you request a test, the independent physician reviews your request and determines whether the test is appropriate for you. If it’s not, you’ll receive a refund. If it is, the physician orders the test, and the lab sends the results to the physician for review. After the physician approves the results, they’re released and delivered to you through our secure HIPAA-protected online results dashboard.

Critical Value and Nationally Notifiable Diseases

At Healthyr, we take all results seriously, especially those with predetermined “critical values.” Our physician network maintains a list of these values and triages all out-of-range results. If you have a critical value result or a positive result for an STI, a physician from your state will contact you directly. With Healthyr’s physician-supported at-home testing, you can take control of your health and get the personalized information you need to make informed decisions about your well-being.

Keeping Your Information Secure

At Healthyr, we take your privacy and security very seriously. We use unique barcode IDs for every sample received by our partner labs. This ID ensures that your results are accurately delivered to you and reduces the chance of any errors caused by human mistakes.

Healthyr’s labs follow strict protocols to process your samples, guaranteeing the highest level of accuracy and quality.
We use validated extraction protocols to ensure the end-to-end process produces the most accurate results possible.

HIPAA Compliance

HIPAA Compliance is a set of rules and regulations that healthcare organizations must follow to protect your personal health information. HIPAA stands for Health Insurance Portability and Accountability Act, a law passed in the United States to ensure patient privacy. 

Healthyr has policies and procedures in place to protect your privacy and trains its employees to follow them.

HITECH Security Standards

The HITECH Security Standards are regulations designed to protect your sensitive health information from theft or unauthorized disclosure. The standards require healthcare organizations and their business associates to implement specific security measures, such as encrypting data and restricting access to authorized personnel.

By following these standards, Healthyr can help ensure that your personal and medical information remains confidential and secure.

We’re proud to be at the forefront of the at-home diagnostic testing field. Our goal is to continually make a real difference in people’s lives. By providing patients with the tools they need to monitor their health more closely, we empower them to take control of their well-being and make informed decisions about their care.

Thank you for choosing Healthyr as your partner in healthcare. We’re dedicated to continuing to innovate diagnostic testing and health solutions that make healthcare more convenient, accurate, and accessible for everyone.