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Everist Genomics in the News
Ann Arbor’s Everist Genomics Develops New Tests for Cancer Risk
December 14, 2011
By Sarah Schmid
There’s a long-held belief that, if caught early, colorectal cancer is almost always treatable through surgery alone. But according to Ann Arbor-based Everist Genomics, nearly one in three Stage 2 colon cancer patients who have surgery alone, without adding chemotherapy, will suffer a recurrence of their cancer. And more than 80 percent of those patients, Everist says, will die from their disease.
Ann Arbor’s Everist Genomics Buys Angiologix Inc.
October 31, 2011
By Matt Roush
CardioDefender Smartphone-based ECG, a 21st Century Holter Monitor
November 9, 2011
By Gene Ostrovsky
Everist Genomics, an Ann Arbor, Michigan company, is set to release its CardioDefender diagnostic system, a smartphone ECG that can provide continuous readings throughout the day that can help detect arrhythmias that may be hard to spot in an office visit. The system uses a wrist watch-like device to collect data from electrodes and transmit it wirelessly via Bluetooth to a smartphone that can then share it with clinicians monitoring the patient. CardioDefender, that recently won both FDA approval and EU’s CE Mark, can activate an alarm to rapidly notify a physician of any particularly unwelcome graph via an email, page, or other electronic means.
Genetic Testing Firms Tout Underlying Bioinformatics Capabilities as Key Business Component
April 26, 2011
Uduak Grace Thomas
Compared to similar products, OncoDefender's approach to testing is more "definitive," providing physicians with more useful information because it has a higher positive predictive value — or the proportion of patients with positive test results who are correctly diagnosed — than the competition….
Gastrointestinal Malignancies
Molecular Tests Focus on Need for Aggressive Therapy
April 2011
Susan London
Advances in molecular prognosis may soon make it possible to predict the risk of recurrence of early colorectal cancer after curative resection - and thus the need for adjuvant therapy in patients who might not otherwise receive further treatment.
Everist hits the market with its colorectal cancer assay
April 13, 2011
Jim Stommen
Armed with the positive results of an external validation study that were unveiled during a conference in San Francisco earlier this year, Everist Genomics (Ann Arbor, Michigan) has reported the worldwide commercial availability of its OncoDefender-CRC colorectal cancer assay. The company describes the assay as the first genetic test to assess risk of recurrence following surgery in both Stage I/II colon cancer and Stage I rectal cancer patients. The test examines expression levels of a panel of genes extracted from formalin-fixed, paraffin-embedded cancer tissue taken at the time of surgery, and uses a proprietary algorithm to generate a yes/no decision identifying patients who are at risk of recurrence.
Gene Tests Predict Risk, Guide Therapy for
Patients with Stage I-III Colon Cancer
March 2011
Caroline Helwick
Study investigators tested OncoDefender-CRC on 115 patients with stage I or II CRC. The results showed that the test correctly identified 32 of 46 cases of recurrence and 38 of 69 cases of nonrecurrence after surgery, for a sensitivity of 70% and a specificity of 55%. High-risk patients had a significantly greater probability of recurrence within 36 months than low-risk patients (HR, 2.06; P=0.02); the positive predictive value (PPV) was 0.51 and negative predictive value was 0.73. In contrast, the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology did not differentiate between high- and low-risk populations (P=0.315). Dr. Lenehan maintained that OncoDefender stands out among its competitors because it has a higher PPV and better sensitivity.
Everist Genomics Appoints President and CEO
Talent Pool by Carolyn Gretton
March 2011
Everist Genomics, a prognostics company focused on developing gene-based molecular assays for the prediction of cancer recurrence, has appointed Prasad Sunkara, Ph.D., president and CEO. Everist recently changed its name from Genetics Squared. Dr. Sunkara succeeds Bill Worzel, who co-founded Everist in 2002 and remains with the company as chief technology officer. He was most recently chairman of Angiologix. Dr. Sunkara received a Ph.D. in microbial biochemistry from Indian Institute of Science.
More Genetic Tests to Predict Recurrence in Stage II Colon
January 20, 2011
The other new test in development, OncoDefender-CRC, tests for only 5 genes and is aimed at stage I and II colon caner patients and stage I anal cancer patients. This test is performed on formalin-fixed paraffin-embedded tissue. Lisa Boardman, MD, from Mayo Clinic in Rochester, Minnesota, and colleagues tested OncoDefender-CRC on 115 patients with stage I or II colorectal cancer. Because it was used on archived tissue, the outcomes were already known. The results showed that the test correctly identified 32 of the 46 cases of recurrence and 38 of the 69 cases of nonrecurrence, for a sensitivity of 70% and a specificity of 55%. High-risk patients had a significantly higher probability of recurrence within 36 months than low-risk patients (hazard ratio, 2.06; P = .02; positive predictive value, 0.51; negative predictive value, 0.73). In contrast, the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology were unable to differentiate between these populations (P = .315), Dr. Boardman reported.
Study Validates Colorectal Cancer Recurrence Test from Everist
January 26, 2011
Everist Genomics (Ann Arbor, Michigan), a prognostics company focused on developing gene-based molecular assays for the prediction of cancer recurrence, reported the positive results of the first external validation study of its OncoDefender-CRC colorectal cancer recurrence test. The study is being conducted by Mayo Validation Support Services, an affiliate of the Mayo Clinic (Rochester, Minnesota) and is being coordinated with investigators and resources from all three Mayo Clinic sites. Everist says the study, presented Saturday at the American Society of Clinical Oncology's 2011 Gastrointestinal Cancers Symposium (ASCO-GI) in San Francisco, demonstrates that the OncoDefender-CRC assay can accurately predict individual recurrence risk in stage I and II colorectal cancer patients.
| Clinical Results January 31, 2011 |
 |
| Product | OncoDefender-CRC |
| Business | Diagnostic |
| Description | Colorectal cancer assay based on a 5-gene prognostic signature |
| Indication | Predict recurrence risk in patients with stage I/II colorectal cancer |
| Endpoint | Colorectal cancer recurrence within 36 months; sensitivity and specificity |
| Milestone | Market launch (1Q11) |
A validation study in primary adenocarcinoma tissues from 115 patients with stage I/II colorectal cancer showed that patients classified as high-risk by Everist’s OncoDefender-CRC assay had a significantly higher probability of cancer recurrence within 36 months compared to patients identified as low-risk (p=0.02). In contrast, standard assessment measures using National Comprehensive Cancer Network (NCCN) clinical practice guidelines were unable to significantly differentiate the risk of colorectal cancer recurrence at 36 months (p=0.315). OncoDefender-CRC had a sensitivity of 70% and a specificity of 55% compared to 72% and 42%, respectively, for NCCN guidelines. Data were presented at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium in San Francisco.
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In The Spotlight: Prasad Sunkara
January 30, 2011
Ann Arbor-based Everist Genomics, formerly Genetics Squared, has named Prasad Sunkara president and CEO. Sunkara, 60, had been chairman of medical diagnostics company Angiologix in Ann Arbor. He succeeds Bill Worzell, who co-founded the company in 2002 and had been CEO since 2006. He remains chief technology officer. Sunkara earned a Ph.D. in microbial chemistry at the Indian Institute of Science and completed a post-doctoral fellowship in cell and tumor biology at the M.D. Anderson Cancer Center in Houston. Everist Genomics focuses on developing gene-based molecular analysis for the prediction of cancer recurrence and the equipment to evaluate and manage cardiovascular disease.
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