genomic health inc (GHDX) Key Developments
Genomic Health Inc. Presents at Goldman Sachs 34th Annual Global Healthcare Conference, Jun-11-2013 02:00 PM
May 24 13
Genomic Health Inc. Presents at Goldman Sachs 34th Annual Global Healthcare Conference, Jun-11-2013 02:00 PM. Venue: Terranea Resort, Rancho Palos Verdes, California, United States.
Genomic Health Inc. Presents at Jefferies 2013 Global Healthcare Conference, Jun-03-2013 04:30 PM
May 21 13
Genomic Health Inc. Presents at Jefferies 2013 Global Healthcare Conference, Jun-03-2013 04:30 PM. Venue: Grand Hyatt Hotel, 109 East 42nd Street at Grand Central, New York, New York, United States. Speakers: Brad Cole, COO.
Genomic Health Announces Availability of Oncotype DX Prostate Cancer Test
May 8 13
Genomic Health Inc. is making its Oncotype DX(R) prostate cancer test available to physicians and their patients following the presentation by the University of California, San Francisco (UCSF) of a positive clinical validation study at the 2013 American Urological Association (AUA) Annual Meeting in San Diego. Results showed that the test, developed in collaboration with UCSF and Cleveland Clinic, strongly predicted disease aggressiveness (p=0.002) offering information beyond currently available clinical factors, such as PSA and biopsy Gleason Score, to help physicians and their prostate cancer patients confidently choose the most appropriate treatment based on an individualized risk assessment. Furthermore, this first-of-its-kind, multi-gene test has been validated to guide treatment decisions using the prostate needle biopsy sample taken before the prostate is removed -- thereby providing the opportunity for low risk patients to avoid invasive treatments such as radical prostatectomy or radiation. Active surveillance is a treatment plan that employs careful and consistent monitoring of the cancer in a man's prostate without removing it. Under active surveillance, patients have regular check-ups and periodic PSA blood tests, clinical exams and potential biopsies to closely monitor for signs of prostate cancer progression. The Oncotype DX prostate cancer test measures the level of expression of 17 genes across four biological pathways to predict prostate cancer aggressiveness. The test results are reported as a Genomic Prostate Score (GPS) that ranges from 0 to 100 and is combined with other clinical factors to further clarify a man's risk prior to treatment intervention. In the UCSF validation study of 395 patients, adding the biological information revealed by the GPS significantly increased the number of patients identified as having very low risk disease and thus appropriate for active surveillance (from 5-10% to 26%). Specifically, more than one-third of patients originally classified as low risk based on clinical measures were identified by GPS as very low risk and could confidently choose active surveillance. Importantly, approximately 10% of patients originally classified as very low or low risk by clinical factors were identified by GPS as having more aggressive disease, which would be considered for immediate treatment. To develop the Oncotype DX prostate cancer test, Genomic Health conducted six feasibility and development studies in collaboration with Cleveland Clinic evaluating more than 700 patients. In the development studies, an optimized RT-PCR platform was used to measure and analyze gene expression in prostate cancer tissue samples from both radical prostatectomy and very small needle biopsy specimens. Out of more than 700 candidate genes, 81 genes were selected to be tested in biopsy samples. The final analysis yielded 17 genes across four biologic pathways and a precise and reproducible GPS to accurately predict disease aggressiveness of the entire prostate prior to intervention.
Genomic Health Inc. Reports Unaudited Consolidated Earnings Results for the First Quarter Ended March 31, 2013; Provides Earnings Guidance for the Second Quarter 2013
May 2 13
Genomic Health Inc. reported unaudited consolidated earnings results for the first quarter ended March 31, 2013. For the quarter, the company’s total revenue increased to $63,094,000 compared with $58,467,000 in the first quarter of 2012. Net loss was $883,000 compared with net income of $777,000 in the first quarter of 2012. Diluted net loss per share applicable to common stockholders was $0.03 for the first quarter of 2013, compared with diluted net income per share of $0.02 for the same period in 2012. Loss from operations was $889,000 compared to income from operations of $871,000 a year ago. Loss before income taxes was $830,000 compared to income before income taxes of $873,000 a year ago.
The company currently expect a net loss of approximately $3 million in the second quarter 2013. The company continue to expect operating expense to increase in the second quarter as the company continue to prepare for and execute the launch of prostate cancer test and further invest in international expansion and product pipeline.
Genomic Health Inc. - Special Call
May 1 13
To discuss the positive development and clinical validation study results of its biopsy-based Oncotype DX prostate cancer test