Frequently Asked Questions

How can my patients participate in the 4myheart Program for cardiovascular disease management?
All patients can participate in the 4myheart Program at no additional cost or obligation for nine months after they have had a Berkeley HeartLab test. Patients can call 800-432-7889, option 3 to set up an appointment with a Berkeley HeartLab Clinical Educator who helps them develop a personalized plan for cardiovascular disease (CVD) risk reduction. However, patients may participate in the 4myheart Program only with their clinician’s approval. New clinicians should contact their Disease Management Consultant or Customer Support to enroll their patients in the 4myheart Program.

What is a Clinical Educator?
Clinical Educators have years of experience working with CVD and stroke patients. They are credentialed as Registered Dietitians (RDs), Registered Nurses (RNs) with cardiac backgrounds, Exercise Physiologists, and more. They undergo rigorous training at BHL to become experts in educating patients on personalized risk reduction plans that incorporate nutrition, exercise, and stress management. They also focus on the importance of medication compliance.

What will Berkeley HeartLab Clinical Educators discuss with my patients?
Clinical Educators (CEs) help patients develop a personalized plan for CVD and stroke risk reduction incorporating the clinician’s treatment plan, genetics, current lifestyle, and health history. This plan is based on the patient's test results as well as their capabilities, motivation, and needs.

How do I login to 4myheart.com?
Instructions for logging into 4myheart.com can be found on the 4myheart.com home page. If you cannot login, please call 800-432-7889 option 3 and ask for 4myheart Support.

Where can I find information on individual tests and their clinical implications?
Test descriptions and our Clinical Implications Reference Manual are available on this website. For more information, call 800-432-7889, option 3 and ask to speak with a Disease Management Consultant.

Are the Berkeley HeartLab tests FDA approved?
Berkeley HeartLab’s HDL and LDL Gradient Gel Electrophoresis tests and all genetic tests were developed, validated and performed as laboratory developed tests (LDTs) solely by BHL, a CLIA certified and CAP accredited clinical laboratory. Under CLIA, BHL was required to establish the performance specifications for these tests, including, accuracy, precision, sensitivity, specificity and limit of detection, prior to offering these tests commercially.¹ The BHL clinical validations for these tests are drawn from published literature. In addition, BHL must comply with regulatory oversight requirements under CLIA and state law, including regular inspections. In fact, the validations for these BHL LDTs are subject to inspection by the Centers for Medicaid and Medicare Services (CMS), the College of American Pathologists (CAP) and the New York Department of Health Services.

Currently, FDA exercises enforcement discretion not to require premarket clearance 510(k) or pre-market approval for LDTs. Under this FDA policy, these BHL tests have not been required to undergo pre-market clearance or approval in order for BHL to offer these tests commercially. Recently, FDA announced that it plans to implement a new regulatory framework for LDTs, under which LDTs will be regulated in some manner. FDA has not yet set forth the details of this new policy. Until such time as this new policy is released by FDA, BHL will continue to offer these tests in compliance with CLIA regulations. As a reminder, FDA clearance or approval is not required for reimbursement nor is it a guarantee for reimbursement.

Our current CLIA, CAP and laboratory certificates and licenses can be accessed here.


¹42 CFR Section 493.1253(b)(2)

How can I obtain a specimen collection kit?
Your Disease Management Consultant can arrange for kits to be sent to you or you can contact Customer Support at 800-432-7889.

How soon can I expect to see my patients’ results?
Test results are usually released no later than 14 days after we receive the sample.

How can I locate my Disease Management Consultant?
Contact Customer Support at 800-432-7889 if you do not have your Disease Management Consultant’s contact information.

How do I get trained on interpreting Berkeley HeartLab test results?
Our Clinical Consultants provide training for clinicians on interpreting the Berkeley HeartLab test report and clinical implications. Contact us at 800-432-7889, option 3 for more information.