Clinical Development at Proventys strives to improve the quality of care by focusing on disease conditions and clinical decision points where the use of personalized, predictive solutions can lead to superior outcomes. Furthermore, in creating advanced decision support solutions, we are dedicated to helping clinicians access and understand the scientific evidence and applicable clinical guidelines that facilitate the delivery of care optimal treatment approaches for patients.

The overall goals of the Proventys clinical development process are threefold:
1. To identify, address, and support clinical decisions that are critical for physicians and are widely recognized as highly complex.
2. To provide the greatest degree of personalization possible to each predictive solution, while still creating tools that are transparent to physicians and fit into their workflow.
3. To conduct rigorous evaluation of all predictive solutions through a series of validation, usability, cost-effectiveness, and clinical outcomes studies.

We believe that the promise of prospective, personalized, preventive medicine will become reality through the use of our advanced decision support solutions, and will expedite the clinically appropriate adoption of new technologies including molecular diagnostic testing (e.g., genomics, proteomics, and metabolomics). Ultimately, we believe the adoption of these technological advances will help control costs and increase the ability of the physicians using them to adhere to best practices, benefiting all stakeholders – and, most importantly, patients.

The following paragraphs describe two of the clinical areas where we believe advanced decision support solutions leveraging personalized, predictive technologies will bring new value to the point of care:

Oncology
The American Cancer Society estimates that there will be 1.44 million cases of newly diagnosed cancer this year.[i] and  almost 600,000 deaths in the U.S. alone. Recent advances in genomics and statistic modeling have allowed the prediction of response to some categories of treatment (e.g. adjuvant therapy).[ii] However, the personalized benefit of selecting specific chemotherapy regimens based on individual patient characteristics remains unknown, both in terms of increased efficacy of treatment and the avoidance of serious adverse events. Both the optimization of regimen selection and risk mitigation could be effected by predictive models provided to the oncologist at the point-of-care. By developing the Proventys PDx Oncology™ system, we will take critical steps toward optimizing the risk mitigation strategies available to oncologists as they select the right chemotherapy regimen for each patient along with the right supportive medications, especially those targeted at preventing the chemotherapy adverse events with the greatest morbidity and mortality.

Febrile neutropenia (FN) is the most deadly complication of chemotherapy, with 14% of all chemotherapy patients developing the complication and 8% of those dying.[iii],[iv] Approximately 50% of patients undergoing chemotherapy will become anemic, but recent findings of adverse events caused by epoetin dictate the judicious use of the drug and assessment of risk.[v] In addition, 12% of chemotherapy patients experience thrombocytopenia.[vi]

Cardiovascular
Overall, there are an estimated 2.3 million affected by acute coronary syndrome each year in the United States.[vii] 13 million patients are evaluated in US Emergency Departments with cardiac enzymes each year[viii], of whom 1.6 million are hospitalized for acute coronary syndrome.[ix] Occlusions in the myocardial vasculature lasting more than 30 minutes lead to infarction, which results in reduced ventricular function, poorer quality of life, and death. This dictates the necessity of prompt and personalized diagnosis, triage and management of suspected cases.
For those patients surviving their MI, prevention of recurrent ischemic events and management of heart failure become central points. Upwards of 25% of patients with MI will experience recurrent events,[x] while heart failure accounts for 550,000 incident cases, 5.3 million prevalent cases and 3.6 million hospitalizations each year. Given the pharmacologic and therapeutic interventions that exist, personalized assessment of risks and benefits associated with various management strategies can help to alleviate the downstream burden of disease.

Endnotes:

ⁱAmerican Cancer Society. Cancer Facts & Figures 2008. http://www.cancer.org/downloads/STT/2008CAFFfinalsecured.pdf . Accessed on 5/21/2008.

ⁱⁱ Paik S, Shak S, Tang G, et al. A multigene assay to predict recurrence of tamoxifen-treated, node-negative breast cancer. N Engl J Med. 2004;351(27):2817-26.

ⁱⁱⁱ Crawford J, Dale D, Wolff D et al. Risk of Neutropenia Events During the First Cycle of Systemic Cancer Chemotherapy: Results from a Prospective Study. Supportive Care in Cancer. 2005; 13: 425. Abstract 06-049.

^iv Crawford J, Dale DC, Lyman GH. Chemotherapy-induced Neutropenia: Risks, Consequences, and New Directions for Its Management. Cancer. January 15, 2004; 100(2): 228-237.

^v Lyman GH, Berndt ER, Kallich JD. The Economic Burden of Anemia in Cancer Patients Receiving Chemotherapy. Value in Health. 8(2): 149-156.

^vi Kuderer NM, Francis CW, Crawford J, et al. A Prediction Model for Chemotherapy Associated Thrombocytopenia in Cancer Patients. J Clin Oncol: 2006 ASCO Meeting Proceedings; 24(18S): Abstract 8616.

^vii AHA Heart Disease and Stroke Statistics-2007 Update.

^viii CDC National Ambulatory Medical Survey: 2005 Emergency Department Summary.

^ix National Center for Health Statistics.

^x Berger et al JAMA 1992