Home 5 Clinical Diagnostics Insider 5 Lab Company Takes Rare Step to Promote Heart Disease Test

Lab Company Takes Rare Step to Promote Heart Disease Test

by | May 27, 2024 | Clinical Diagnostics Insider, FDA-dtet

Publishing peer-reviewed studies to tout the economic benefits of medical devices is fairly commonplace, but rare for a laboratory company

Using peer-reviewed academic studies as a promotional tool has long been the province of biotech companies trying to prove the efficacy and cost savings of their new devices. However, that strategy has been rarely pursued in the laboratory arena.

Enter Chicago-based Cardio Diagnostics, which aims to break tradition. It recently published a study in the journal Advances in Therapy highlighting its PrecisionCHD™ test for detecting coronary heart disease (CHD). The study concluded that use of the test could save health plans tens of millions of dollars a year.1

The study, “The Use of Precision Epigenetic Methods for the Diagnosis and Care of Stable Coronary Heart Disease Reduces Healthcare Costs,” examined the expenses associated with standard methods of diagnosing CHD. That includes conducting an angiography, the one fail-safe way to guarantee an accurate diagnosis. However, that procedure costs more than $9,400 on average in the US. Other less specific tests for CHD diagnosis range in cost from about $800 to more than $4,400.1

The study examines replacing these tests with the PrecisionCHD™ assay—a blood-based multiomic DNA test using epigenetic and genetic biomarkers and artificial intelligence—to detect CHD. It concluded that by eliminating testing such as angiograms, stress echocardiograms, and single-photon emission computed tomography, a health plan with 1 million enrollees would save about $113.6 million a year.1

Meesha Dogan, Cardio Diagnostics co-founder, chief executive officer, and one of the authors of the study, observed that such a study often satisfies questions currently being asked by payers and providers about lab tests.

“In the payer world, and nowadays more providers—including provider-led health plans—are very interested in understanding how the cost compares when it comes to things like economic savings,” Dogan said in an interview. “It’s a question we get asked often enough and we believe that there’s also an economic argument, in addition to the performance of the task on the clinical side and what it can do.”

Moreover, publishing findings in peer-reviewed journals tends to bolster the transparency of the claims being made, according to Dogan. “It’s being able to talk about those things in a way where others have reviewed what we have done and have published it,” she noted.

Such studies have helped boost conversations with those interested in purchasing tests. Payers are also often playing catchup with their claims data, which is always retrospective. A quick lab test can give the plan a much better idea of what percentage of their population has coronary heart disease and is therefore at greater risk of heart attacks or other medical events.

At a retail price of $850, PrecisionCHD™—which received its own CPT code, 0449U, from the American Medical Association earlier this year—is not inexpensive.2 But if it can give a health plan or a self-insured employer group a better handle on their future claims costs, that can make it an attractive proposition, Dogan said. Moreover, purchasers can obtain discounts for buying the tests in bulk. The test is also offered to consumers through the Navierre telehealth platform.

Dogan was reluctant to talk about employer groups that have signed up to use the test because many deals are still being negotiated, but one company that is onboard is FRSTeam of East Kansas and West Missouri, which specializes in cleaning and restoring the contents of homes and businesses that have been subject to fire or smoke damage. Company employees participated in a heart disease fair with Cardio Diagnostics last August.3

“There are many other employers we’re engaging with right now,” Dogan said.


  1. https://link.springer.com/article/10.1007/s12325-024-02860-7
  2. https://cardiodiagnosticsinc.com/cardio-diagnostics-announces-publication-of-study-showing-that-its-precisionchd-test-could-save-health-insurers-over-113-million-annually/
  3. https://cardiodiagnosticsinc.com/cardio-diagnostics-partners-with-frsteam-of-east-kansas-and-west-missouri-to-host-first-onsite-heart-disease-fair-in-kansas-using-epigenetic-genetic-technologies/


Key recent FDA approvals of laboratory-related platforms, IVD devices, and over-the-counter tests and products include:

Company Name Approval Date What Was Approved Complexity
bioMérieux May 9, 2024 Two approvals for the VIDAS® 3 automated enzyme-linked fluorescent assay Moderate
Sysmex May 8, 2024 18 approvals for the Sysmex CS-5100 automated blood coagulation analyzer High/Moderate
Siemens Healthineers May 8, 2024 18 approvals for tests for the Sysmex CS-5100 automated blood coagulation analyzer High/Moderate
Siemens Healthineers May 8, 2024 18 approvals for tests for the CS-2500 automated blood coagulation analyzer High/Moderate
Sysmex May 8, 2024 18 approvals for the CS-2500 automated blood coagulation analyzer Moderate
Abbott Molecular May 8, 2024 Two approvals for the Alinity m system for testing for herpes simplex Moderate
CITEST DIAGNOSTICS May 7, 2024 52 approvals for the CITEST Multi-Drug Rapid Test Cup Moderate
TransMed Company May 7, 2024 16 approvals for the UScreen™ Rapid Drug Test Cup Waived
PerkinElmer May 3, 2024 Approval for the EnSight multimode plate reader High
Q-linea May 3, 2024 Approval for a blood culture analyzer Moderate
Cepheid May 3, 2024 Approval for the GeneXpert® touchscreen testing system High
HANGZHOU ALLTEST BIOTECH CO. May 3, 2024 Approval for an early pregnancy rapid test OTC/Waived
Walgreen Co. May 2, 2024 Approval for pregnancy test strips OTC/Waived
DiaSorin May 2, 2024 One approval each for the LIAISON® XS and XL analyzer Moderate
Cepheid May 2 & 3, 2024 29 approvals for the GeneXpert® touchscreen testing system Moderate
Beckman Coulter May 1, 2024 Six approvals for insulin chemistry analyzers Moderate
CITEST DIAGNOSTICS April 30, 2024 Two approvals for a combination rapid pregnancy test Moderate/Waived
Roche Diagnostics April 29, 2024 Three approvals for a cobas® test for methotrexate Moderate
Microlife USA April 26, 2024 Approval for the Microlife SmartBG Blood Glucose Monitoring System Waived
Sectra AB April 25, 2024 Approval for the Sectra Digital Pathology Module (3.3) formalin-fixed, paraffin-embedded tissue slides High
Beckman Coulter April 25, 2024 Two approvals for the DxI 9000 Access Immunoassay Analyzer (EPO and ostase) Moderate
Shenzhen New Industries Biomedical Engineering Co., Ltd. April 24, 2024 Approval for the MAGLUMI X3 fully-automatic chemiluminescence immunoassay analyzer Moderate
Healgen Scientific LLC April 23, 2024 32 approvals for the Healgen Accurate home and workplace urine test OTC/Waived
Acro Biotech April 22, 2024 28 approvals for the Acro single drug urine test strip OTC/Waived
Source: FDA CLIA and OTC databases

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