Prime Genomics, Inc. — Department of Health and Human Services SBIR Phase I: 102

Description

Breast cancer screening by mammography is part of routine wellness care for women starting at around agein the United Statesmillion women are screened annually with mammograms to detect thenew cases of breast cancer that occur each yearMammograms still missof cancersand sensitivity falls toin women with high density breastswhich is more common in younger womenHigh breast density is itself considered a risk factor for breast cancerBCand the FDA has declared managing breast density information a major policy goal forMore women are also now identified as at high risk for breast cancer with commonly available genetic testingDetection of breast cancer at its earliestcurable stages is precisely when imaged based screening methods are more likely failImaging methods clearly play an important role in early BC detectionproviding structural information about the tumorbut are not fail proofand would benefit from complementary screening toolsespecially in cases where imaging is more likely to failyounger womenhigh breast densityPrecision medicine approaches and liquid biopsies have the potential to transform cancer detection and managementSaliva is a noninvasive biofluid that contains functional biomarkersincluding RNAprotein and metabolitesBiomarkers for many diseases have been identified in salivaincluding breast cancerAs a screening methodsaliva sampling is noninvasive and easy to collectand compatible with procedures at the point of caresuch as at breast imaging clinicsTo datesaliva based diagnostic efforts have largely been undertaken in academiawithout a comprehensive industry initiated approach for product development and commercializationIn this phaseprojectA NoninvasivePrecision Medicine Approach to Improve Breast Cancer Screening Using Cell free RNA from Salivawe propose to develop the first saliva based companion screening diagnostic for BCOur prototype test called CertinaTM was developed by applying our proprietary and novel algorithmic approach to gene expression microarray data from saliva collected from BC patients and has been validated in two separate clinical cohortsOur initialgene signature has ansensitivity andspecificity for invasive BC detectionIn this phaseprojectour objectives are to develop a saliva collection kit optimized for collection of our signature RNAwith room temperature stability for collection and transportwith our partner Oasis Diagnosticsa leader in the field of saliva collection devicesestablish a saliva biobank for BC assay validationpartnering with Cancer Research Collaborations in Southern California to collect a wide range of clinical samples for longitudinal studies and for use in assay improvementassess the accuracy of our signature in early stage breast cancer and in women with dense breastsas well as improve performance of the CertinaTM assayCompleting these objectives will provide the tools for a Phase II large scale studypairing our test with primary screening in breast cancer as the first saliva based commercial diagnostic for breast cancer Breast cancer screening by mammography is part of routine wellness care in the US for women overbut has detection rates as low asin some groups of womenand a high false positive raterequiring additional follow up and invasive biopsies to ensure the absence of cancerA saliva based diagnostic test for breast cancer is proposed herethat has potential for tremendous public health impact to transform and enhance breast cancer screeningThe proposed test is a noninvasivegene expression based test from salivawhich will complement image based structural information with biological informationimprove breast cancer detectionreduce false alarmsand simplify screening workflows