DNA Methylation Signatures for Prediction of Biochemical Recurrence After Radical Prostatectomy of Clinically Localized Prostate Cancer

“Purpose: Diagnostic and prognostic tools for prostate cancer (PC) are suboptimal, causing overtreatment of indolent PC and risk of delayed treatment of aggressive PC. Here, we identify six novel candidate DNA methylation markers for PC with promising diagnostic and prognostic potential…We identified six novel candidate DNA methylation markers for PC. C1orf114 hypermethylation and a three-gene methylation signature were independent predictors of time to biochemical recurrence after RP in two PC patient cohorts.”


Diagnostics Company Ready to Patent Test for Squamous Cell Lung Cancer

The molecular diagnostics company Rosetta Genomics has received permission to patent their Rosetta Lung Cancer Test. The test analyzes lung tumor tissue and distinguishes squamous cell carcinoma (SCC) from other types of non-small cell lung cancer (NSCLC). Clearly identifying a patient’s cancer subtype is becoming increasingly important for choosing an optimal treatment plan, thanks to the increasing role of targeted therapies and the growing understanding of how drug effects can differ among various cancer subtypes. For example, pemetrexed (Alimta) and bevacizumab (Avastin) benefit many NSCLC patients, but are not recommended for those with SCC. The patent allowance will permit Rosetta to develop their test for use in patients.


Laboratory-Developed Tests Need to Be Better Regulated

Diagnostic medical tests, including those used to detect cancers, usually have to be examined by the U.S. Food and Drug Administration (FDA) for safety and accuracy before getting approved. However, tests created by clinical laboratories (so-called laboratory-developed tests or LDTs) are exempt from this requirement. Such tests were originally intended for internal and research use only. However, with the rise of commercial laboratory testing companies, LDTs are reaching the general patient population. Because these tests have not been proven to deliver accurate and meaningful results, they could potentially mislead and harm patients. The FDA has drawn up a draft guidance document outlining better regulation for LDTs, but it is currently stalled in committee.


Laboratory-Developed Tests Need to Be Better Regulated

Diagnostic medical tests, including those used to detect cancers, usually have to be examined by the U.S. Food and Drug Administration (FDA) for safety and accuracy before getting approved. However, tests created by clinical laboratories (so-called laboratory-developed tests or LDTs) are exempt from this requirement. Such tests were originally intended for internal and research use only. However, with the rise of commercial laboratory testing companies, LDTs are reaching the general patient population. Because these tests have not been proven to deliver accurate and meaningful results, they could potentially mislead and harm patients. The FDA has drawn up a draft guidance document outlining better regulation for LDTs, but it is currently stalled in committee.


Laboratory-Developed Tests Need to Be Better Regulated

Diagnostic medical tests, including those used to detect cancers, usually have to be examined by the U.S. Food and Drug Administration (FDA) for safety and accuracy before getting approved. However, tests created by clinical laboratories (so-called laboratory-developed tests or LDTs) are exempt from this requirement. Such tests were originally intended for internal and research use only. However, with the rise of commercial laboratory testing companies, LDTs are reaching the general patient population. Because these tests have not been proven to deliver accurate and meaningful results, they could potentially mislead and harm patients. The FDA has drawn up a draft guidance document outlining better regulation for LDTs, but it is currently stalled in committee.


Catastrophic Nuclear Envelope Collapse in Cancer Cell Micronuclei

“During mitotic exit, missegregated chromosomes can recruit their own nuclear envelope (NE) to form micronuclei (MN). MN have reduced functioning compared to primary nuclei in the same cell, although the two compartments appear to be structurally comparable. Here we show that over 60% of MN undergo an irreversible loss of compartmentalization during interphase due to NE collapse. This disruption of the MN, which is induced by defects in nuclear lamina assembly, drastically reduces nuclear functions and can trigger massive DNA damage. MN disruption is associated with chromatin compaction and invasion of endoplasmic reticulum (ER) tubules into the chromatin. We identified disrupted MN in both major subtypes of human non-small-cell lung cancer, suggesting that disrupted MN could be a useful objective biomarker for genomic instability in solid tumors. Our study shows that NE collapse is a key event underlying MN dysfunction and establishes a link between aberrant NE organization and aneuploidy.”


Evaluating Small Cell Lung Cancer with PET-CT Scans Improves Survival

Accurately ‘staging’ small cell lung cancer (SCLC), that is, determining its extent and spread in a patient, is crucial in choosing treatment. One year after treatment guidelines began recommending positron emission tomography – computed tomography (PET-CT) instead of bone scans for the initial evaluation of all newly diagnosed SCLC patients, researchers confirmed that the new staging method improved outcomes. A study of SCLC patients diagnosed with limited-stage disease (ie, cancer that is confined to only one lung or its immediately surrounding tissue) showed that those who had received PET-CT staging before their treatment had higher 3-year survival rates (47% vs 19%) than those who did not.


Study Validates Decipher Prostate Cancer Test As Most Accurate Tool For Predicting Prostate Cancer Recurrence

In a clinical trial, Decipher, a new prostate cancer test made by GenomeDx Biosciences, more accurately classified the risk of recurrent, metastatic prostate cancer in patients after surgical removal of the prostate gland than existing risk assessment tools, including Gleason score and prostate-specific antigen (PSA) testing. The clinical study involved 1,010 patients determined to be at high risk of metastasis after prostate surgery and was able to reclassify 60 percent of them as low-risk, minimizing the need for aggressive treatments and their associated side-effects. Of the reclassified patients, 2.4 percent developed metastatic prostate cancer within five years. The results show better performance than any risk assessment methods currently available. Data from the clinical trial are being published in the Journal of Urology, and the company plans to make Decipher more widely available later this year.


Role of Engrailed-2 (EN2) as a Prostate Cancer Detection Biomarker in Genetically High Risk Men

“Controversy surrounds the use of PSA as a biomarker for prostate cancer detection, leaving an unmet need for a novel biomarker in this setting; urinary EN2 may identify individuals with clinically relevant prostate cancer. Male BRCA1 and BRCA2 mutation carriers are at increased risk of clinically significant prostate cancer and may benefit from screening. Urine samples from 413 BRCA1 and BRCA2 mutation carriers and controls were evaluated. Subjects underwent annual PSA screening with diagnostic biopsy triggered by PSA > 3.0 ng/ml; 21 men were diagnosed with prostate cancer. Urinary EN2 levels were measured by ELISA and had a sensitivity of 66.7% and specificity of 89.3% for cancer detection. There was no statistically significant difference in EN2 levels according to genetic status or Gleason score. Urinary EN2 may be useful as a non-invasive early biomarker for prostate cancer detection in genetically high-risk individuals.”