July 12, 2016 | Diagnostic news and product launches include prostate cancer diagnostic test gets expanded coverage, Baylor University partners on a Hong Kong center for medical genetics, and Sure Genomics launches a family health app.
Liquid Biopsy Differentiating Cancer
Epic Sciences has unveiled a liquid biopsy test that more sensitively detects cancers susceptible to PARP inhibitors by targeting homologous recombination deficiency (HRD) in individual circulating tumor cells (CTCs). The new test has already been incorporated into numerous clinical studies of HRD-targeted therapeutics in multiple cancer types. Epic Sciences and Memorial Sloan Kettering Cancer Center presented data at the annual ASCO meeting that suggests that Epic Sciences’ new test can detect a tumor cell’s HRD status based solely on analysis of protein expression and cellular morphology, independent of genomic sequencing. The Epic Sciences HRD liquid biopsy test is being offered as part of its expanded menu of Biopharma Solutions. Press release.
Expanded Coverage for Prostate Cancer Diagnostic
MDxHealth SA has contracted with Priority Health, a Michigan-based health plan with nearly 720,000 members, for coverage of ConfirmMDx for Prostate Cancer testing for its Commercial and Medicare Advantage members. ConfirmMDx for Prostate Cancer is recommended in the 2016 NCCN Guidelines for Early Detection of Prostate Cancer for the management of men with a negative biopsy result. Each year, more than 1 million American men undergo a prostate biopsy with a negative result, however ~30% of those men actually have prostate cancer. The current standard of care for prostate biopsy procedures samples less than 1% of the prostate, leaving men at risk for undetected cancer and leading to a high rate of repeat biopsies, even on cancer-free men. ConfirmMDx helps urologists identify men who may forego an unnecessary repeat biopsy and also distinguish high-risk men who may benefit from intervention. When ConfirmMDx is negative, the test provides a very high negative predictive value (NPV) of 96% for clinically significant prostate cancer, and 90% NPV for all prostate cancer. When the test is positive, the results indicate the likelihood of detecting aggressive, potentially lethal prostate cancer upon biopsy as well as prostate map to help guide repeat biopsies. To date, ConfirmMDx testing has been ordered by nearly 3,000 urologists and performed on over 45,000 patients. The test has qualified for Medicare reimbursement and is also available to more than 152 million insured lives via private health insurance plans. Press release (PDF).
Baylor, Chinese University of Hong Kong Launch Joint Center for Medical Genetics
Baylor College of Medicine and The Chinese University of Hong Kong have signed a memorandum of understanding to establish The Chinese University of Hong Kong-Baylor College of Medicine Joint Center for Medical Genetics in Hong Kong.
The aims of the Joint Center are to:
- Design, establish and conduct training in clinical genetics and genetic counseling that suits the increasing need in Hong Kong, mainland China and the Asia region.
- Establish a leading referral center in Asia for prenatal and postnatal diagnosis and treatment for patients and families affected by genetic disorders.
- Conduct cutting-edge, interdisciplinary basic and translational research that will lead to advances in screening, diagnosis and therapy of genetic disorders as well as new discovery of the underlying genetic mechanism of diseases.
- Host a series of pan-Asian symposia on state-of-the art clinical genetics care and research.
The center will be co-directed by Dr. Brendan Lee, the Robert and Janice McNair Endowed Chair in Molecular and Human Genetics and professor and chair of the department of molecular and human genetics at Baylor, and Dr. Tak Yeung Leung, head of maternal and fetal medicine in the department of obstetrics and gynecology at The Chinese University of Hong Kong. Press Release.
Personal Genomics Company Launches Family Health App
Sure Genomics has announced a partnership with Sanitas, Inc. to offer its Family Healthware application to consumers. Family Healthware is the only health risk assessment service with FDA 510(K) clearance for identifying a person’s familial risk for heart disease, stroke, diabetes, and colorectal, breast and ovarian cancers, and provides a personalized prevention plan to help reduce risk factors for these diseases. To create an overall health risk score, Family Healthware uses a quick, interactive questionnaire to collect health data, behaviors, recent lab tests and family medical history. Through the application, users can invite their relatives to participate, and keep a record of all information including family medical history, personal health information, and ancestry to reveal a more comprehensive family health history record which can be shared with their healthcare providers. Sure Genomics’ SureDNA is the first personalized genomics service that uses the full DNA sequence to round out an individual’s proactive health portfolio. Consumers and their healthcare providers now have access to genetic information for life. The full genome sequence is stored in Sure Genomics' SureVAULT so interpretations can be continually updated without further sample collection or laboratory testing. Because only a single test is required, the time and cost savings over a lifetime become significant. Genetic testing requires a physician order, which can be provided by the individual’s healthcare provider or by a reference network of physicians. Press Release.