Making Diagnostics More Accurate and Cost Effective

Celula, Inc. is a diagnostic testing services company focused on significantly improving the accuracy of diagnosing major diseases, enabling better patient care and improved outcomes. Celula’s unique cost effective “Integrated Diagnostic Accuracy” platform (IDA) consists of algorithmically combining proprietary technologies and non-proprietary technologies that together achieve significantly greater accuracy compared to current tests. The IDA test results have the potential to achieve a much higher positive predictive value (PPV) for presence of disease and greatly decrease unnecessary interventions caused by false positive results. The actionable results will be delivered in a customized Integrated Patient Report (IPR) that facilitates decision making for both the patient and the physician. The company’s initial products will focus on improving the diagnostic accuracy of major women’s diseases, specifically in gynecologic cancers and non-invasive prenatal diagnosis. Celula has an established infrastructure in both the U.S. and China allowing it to develop new products in a significantly more capital efficient manner as well as expand its commercial opportunities beyond the U.S. The company is headquartered in San Diego, California and has development facilities in Chengdu, China.

Solving the problem – How to navigate today’s complex diagnostic landscape and avoid inefficient diagnostic odysseys for patients, physicians, and payers.

Physicians and patients are faced with an exponentially growing complexity of diagnostic options and new technologies that are difficult to understand and navigate. It is growing more challenging for busy clinicians to keep abreast of the many scientific advances, while balancing financial and quality pressures from an increasingly managed practice setting. This is especially true in diagnostics, where the rapid proliferation of tests make it difficult to assess what is the most appropriate testing paradigm for their individual patients. Prime examples include the many new prognostic genomic cancer tests and DNA based disease-screening tests such as the recently introduced non-invasive prenatal fetal DNA tests for aneuploidy detection. The high false positive rates can result in unnecessary and sometimes harmful procedures performed on patients that do not have the disease. There is no single integrated commercial solution today that can achieve the desired diagnostic accuracy in all populations. Celula is focused on providing that solution for major high impact diseases.

A key differentiating component of the company’s CLIA lab services model will be its Integrated Patient Report (IPR). The custom report improves patient and physician comprehension of results and streamlines the busy physician’s consultative decision process with the patient. By tailoring the results to a specific patient, more meaningful discussion can occur regarding the patient’s management.

The single largest error in laboratory medicine is choice of the wrong test, which is estimated to occur 10-20% of the time and probably much more commonly for highly complex tests. Celula integrates clinical market and disease knowledge with its cost advantaged proprietary technologies in DNA and cellular analysis to produce the most accurate and cost-effective diagnostic solution- the Integrated Diagnostic Accuracy solution (IDA). This is accomplished through the application of a multi-test paradigm that is validated to generate actionable results for patient management and match the requirements of the patient’s health care provider for reimbursement.