If Diagnostics Matter to You, You Matter to Health Decisions

Health Decisions Navigation Icon Diagnostics

Health Decisions is committed to enabling diagnostics developers to bring new products to market with maximum quality, speed and efficiency. We have successfully executed studies of a variety of IVDs and LDTs, including studies that resulted in PMA approval, 510(k) clearance or dual 510(k)/CLIA waiver clearance. Large subject-based IVD studies are a particular strength. We have an extensive site network, effective relationships with appropriate IRBs and a feasibility process refined to support site selection in diagnostics studies. Health Decisions welcomes the opportunity to serve as an extension of your diagnostics development team. Learn more about Health Decisions’ capabilities in diagnostics studies from this fact sheet. Please also visit our diagnostics library.

We understand the requirements and challenges of PMA, 510(k) and dual 510(k)/CLIA waiver studies

Health Decisions understands device regulations and the unique requirements of subject-based IVD studies of all types and sizes. Our leading regulatory advisor is a PhD microbiologist with extensive expertise in diagnostics development who has advised diagnostics companies from multinational giants to innovative startups on regulatory strategy for a wide variety of diagnostics. Our clinical affairs and biometrics teams have supported numerous clients in successful PMA, 510(k) and dual 510(k)/CLIA waiver submissions, providing services including study design, regulatory strategy, study execution, including project management and clinical and technical monitoring, and submission preparation and filing. Technical monitoring experience includes maintenance, calibration and quality control of devices and/or assays and analytical troubleshooting of device and/or assay performance throughout the testing life cycle (quality control, repeatability, reproducibility, method comparison).

Our IVD capabilities encompass:
  • Projects at all stages, including sample collection, analytic validation, reproducibility and repeatability, clinical validation and clinical utility

  • Collection and shipment of all types of serology, cytology and other specimens

  • Studies involving all types of settings, including labs, point-of-care facilities, phase 1 centers and subject homes

  • Collection of many types of data, including lab results, CRFs, usability questionnaires, QOL surveys, diaries, Visual Analog Scales and spirometry results

  • Studies in a wide range of indications in oncology, infectious disease and women’s health

  • Studies in all major regulatory pathways, including PMA, 510(k) and dual 510(k)/CLIA waiver

PMA Studies

Health Decisions’ experience in PMA studies includes a study of a diagnostic for high-risk HPV that screened more than 50,000 women and enrolled 4,071 women with Pap smear results positive for Atypical Squamous Cells of Undetermined Significance (ASCUS). Health Decisions has conducted several large studies of diagnostics for colorectal cancer, including a successful PMA study of a stool-based diagnostic enrolling ≈ 13,000 subjects. Both the HPV study and the CRC diagnostics study involved comparison of results from the investigative diagnostic with the consensus of a panel of pathologists examining tissue from the same subjects. Health Decisions performed in-house monitoring of pathology results in addition to onsite monitoring of sample-collection sites.

Case Study

Read this case study to learn how Health Decisions addressed complex challenges in cohort management, sample management and subject compliance in a   ≈ 13,000-subject PMA study of a novel noninvasive screening diagnostic for colorectal cancer. The study supported a successful PMA submission.

Download PDF

510(k) Studies

Health Decisions has conducted studies to support multiple types of submissions for 510(k) clearance. This includes typical 510(k) studies that compare a novel diagnostic to a currently marketed predicate device as well as the 510(k) de novo pathway that is available when FDA waives the requirement to identify a predicate device. FDA makes such a determination based on an assessment that risks associated with the use of the novel diagnostic do not rise to the level of requiring a PMA submission. Health Decisions also understands the increasingly popular pathway involved when FDA requests a dual 510k/CLIA waiver submission. We have successfully mitigated the risks of this combined pathway to ensure reliable and accurate data while working closely with study sponsors to reduce costs by comparison with conducting two separate clinical trials. In summary, Health Decisions’ experience with 510(k) studies includes:

  • Standard 510(k) studies demonstrating substantial equivalence with predicate devices

  • 510(k) de novo studies that do not involve a predicate device

  • Studies to support dual 510(k)/CLIA waiver submissions

  • 510(k) studies of point-of-care (POC) diagnostics

Case Study

This case study describes how Health Decisions successfully addressed multiple challenges in a 510(k) study of a novel diagnostic for respiratory tract infections. Challenges addressed included ensuring rapid sample collection and accurate sample tracking, maintaining sample integrity and performing effective cohort management to meet goals for demographic diversity.

Download PDF

CLIA Waiver

Health Decisions understands the intricacies of obtaining a CLIA waiver and has successfully performed studies to secure this waiver for sponsors. We understand the risk of utilizing naïve operators (non-lab professionals) to perform testing on novel devices and the importance of offering no hands-on training to the naïve operators participating in these trials. With our technical monitoring abilities, Health Decisions not only can evaluate the results of the tests performed by the naïve operators but also provide the sponsor key observations and feedback from testing personnel to assess the clarity of instructions presented and identify potential improvements before product launch.

Case Study

Read this case study to learn how Health Decisions successfully conducted a dual 510(k)/CLIA waiver study of an investigational point-of-care (POC) diagnostic for influenza, addressing challenges including ensuring compliance with complex sample-collection requirements and enrolling the study rapidly after a late start in the flu season because of delayed availability of the investigational device. Health Decisions assisted with the development of self-guided training materials for naïve site staff and performed a familiarization experiment to ensure that staff could adequately perform testing on the POC device before enrollment of patients. In addition, Health Decisions used uploaded smartphone photographs to track the quality of results from the investigational diagnostic in real time.

Download PDF

Clinical Validity and Clinical Utility

Increasingly, diagnostics developers must demonstrate a link between diagnostic result and improved patient outcome to ensure clinician acceptance and healthcare payer reimbursement. In addition, evidence of clinical utility is the strongest foundation for successful widespread marketing of any diagnostic. Clinical validation – determining a test’s ability to diagnose a health condition or predict risk of clinical outcomes – may fail to convince physicians and especially healthcare payers to accept a new diagnostic. Failure to gain payer acceptance may even result in business failure for the developer. Health Decisions can assist sponsors in demonstrating the clinical utility of novel diagnostics.

A clinical validation study demonstrates a test’s ability to diagnose a health condition or predict risk of clinical outcomes. Health Decisions has conducted successful clinical validation studies of diagnostics in a variety of oncology, infectious disease and women’s health indications. These clinical validation studies have contributed to successful submissions for 510(k) clearance and PMA approval.

Clinical Utility White Paper

This white paper provides tips for successfully establishing the clinical utility of molecular diagnostics in order to ensure healthcare payer reimbursement and clinician adoption. Increasingly, diagnostics developers must demonstrate a link between diagnostic result and improved patient outcome. This is true despite the many steps and considerable time that often come between test and outcome, including treatment decision, treatment and patient compliance or noncompliance. Ten Tips for Establishing the Clinical Utility of Molecular Diagnostics describes techniques for identifying and executing the optimal strategy for establishing clinical utility, including strategies for determining the need for a clinical trial to assess outcomes and efficiently conducting such a trial if required.

Download PDF

Sample Collection

Sponsors often require assistance obtaining prospective or retrospective samples at different stages of development. Initial development of a diagnostic may utilize banked or contrived samples but as development advances, it becomes increasingly important to demonstrate that the test produces accurate results with samples collected prospectively from an appropriate patient population in the intended setting and in accordance with specific instructions to be provided with the diagnostic, whether for collection by an approved or investigational method or tube.  Conducting efficient sample-collection studies requires understanding the therapeutic landscape for the relevant indication, including the types of physicians providing treatment, the standard of care and the patient flow at typical treatment centers. Health Decisions and our clinical staff have relationships with treatment sites for many indications and utilize rigorous feasibility processes to identify appropriate sites for sample collection as sponsors require.

  • Whole blood

  • Serum/plasma

  • Cytology specimens

  • Tissue blocks

  • Wet tissue

  • Vaginal swabs

  • Nasopharyngeal and midturbinate swabs

  • Sputum

  • Urine

  • Stool

Repeatability and Reproducibility

A critical step in diagnostics development is demonstrating that an investigational diagnostic produces consistent results when used by the same operator over time, by different operators within a single lab and by different operators across multiple labs. Repeatability within a laboratory must be demonstrated within and between runs of the assay. Health Decisions understands the FDA guidelines around repeatability & reproducibility as standalone measurements and in combination with a PMA, 510(k) or CLIA waiver study. Health Decisions and our technical staff have extensive experience and expertise in management and monitoring of studies to demonstrate repeatability and reproducibility.

Therapeutic Experience

Health Decisions has conducted studies of investigative diagnostics in a wide range of therapeutic areas and indications, including:

  • Human papilloma virus (HPV)

  • Risk of preterm birth

  • Intraamniotic infection

  • Chlamydia trachomatis & Neisseria gonorrhea

  • Urothelial carcinoma

  • Colorectal cancer

  • Prostate cancer

  • Differentiated thyroid cancer

  • Influenza and other respiratory viruses

  • Fungal infections