If Diagnostics Are Important to You, You Are Important to Health Decisions
Health Decisions is committed to enabling diagnostics developers to bring new products to market with maximum quality, speed and efficiency. We have successfully executed a variety of IVD studies, including studies that resulted in PMA approval or 510(k) 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 IVD studies. Health Decisions welcomes the opportunity to serve as an extension of your IVD development team.
We understand the requirements and challenges of PMA, 510(k) and 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 and 510(k) submissions, providing services including study design, regulatory strategy, study execution and submission preparation and filing.
Our IVD experience encompasses studies in a wide range of indications, including:
- Oncology and related indications, including studies in CRC, urothelial carcinoma, differentiated thyroid cancer, HPV and prostate cancer
- Infectious disease indications, including studies in influenza, other respiratory infections, STIs (CT, NG, HPV) and fungal infections
- Women’s health indications, including risk of pre-term birth and high-risk HPV
- In all major regulatory pathways, including PMA, 510(k), and CLIA waiver
- At all stages of test development, including sample collection, validation, reproducibility and repeatability, clinical validation and clinical utility
- Involving all types of samples (blood, urine, stool, vaginal swabs, nasopharyngeal swabs, tissue)
- Evaluating tests used in a variety of settings: labs, point-of-care, subject homes
- Collecting a variety of data: lab results, CRFs, QOL surveys, diaries, Visual Analog Scales, spirometry data, etc.)
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 almost 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.
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. View the case study.
Clinical Validity & 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 the white paper on demonstrating clinical utility.
Obtaining a CLIA waiver requires demonstrating that a test is simple enough to minimize risk of error when used by non-lab-professionals such as home users or medical staff at the point of care. To qualify for waiver, such tests must use unprocessed specimens, be easy to use and present little risk of an incorrect result. A critical step in demonstrating that a test can be waived is having the intended users perform the test based solely on the instructions for use that will be available with the product. Thus, a clinical study must not only evaluate the results of tests performed by the intended users, but also ensure that they perform the test with no directions or assistance beyond what the instructions provide. Health Decisions and our clinical staff are experienced at managing and monitoring studies to enable sponsors to obtain CLIA waivers.
Repeatability & 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. FDA typically requires testing with multiple operators at a minimum of three different sites. Tests may be run in duplicate with a minimum of two runs per day for a required number of days. The three operators may each be required to use a different piece of equipment and set of reagents. Health Decisions and our clinical staff are experienced and expert at managing and monitoring studies to demonstrate repeatability and reproducibility.
Sponsors often require assistance obtaining prospective 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. Conducting efficient sample-collection studies requires understanding the therapeutic landscape for the relevant indication, including the types of physicians treating the indication, 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.