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C2N Diagnostics Expands Partnership with Washington University School of Medicine to Commercialize a Clinical Blood Test for Detection of Early Alzheimer’s Disease

C2N Diagnostics, LLC (C2N) recently announced that it has expanded its partnership with Washington University School of Medicine (WUSM) in St. Louis. The objective of this collaboration is to commercialize a clinical blood test for detecting the earliest stages of Alzheimer’s disease (AD) as well as mild cognitive impairment (MCI). Under terms of the agreement, C2N has acquired the exclusive worldwide commercial license rights to a suite of technologies developed in the laboratories of Professors Randall Bateman, MD and David Holtzman, MD, in the Department of Neurology at WUSM.

Pretesting Cervical Tumors Could Inform Treatment

Doctors at Washington University School of Medicine in St. Louis have shown that testing cervical tumors before treatment for vulnerability to chemotherapy predicts whether patients will do well or poorly with standard treatment. The study supports the future possibility of personalized medicine for cervical cancer, a tumor normally addressed with a one-size-fits-all approach.

“Even though this is a small study, its strength is that it links a lab test of the tumor’s chemotherapy response to survival outcomes for the patients,” said Julie K. Schwarz, MD, PhD, assistant professor of radiation oncology. “Very few cancers have been studied this way, and this is the first such report for cervical cancer.”

Since 1999, nearly all cervical cancer cases have been treated the same way: daily radiation therapy targeted to the tumor plus a weekly intravenous infusion of the chemotherapy drug cisplatin.

“We believe that radiation does the majority of the work with cervical cancer,” said Schwarz, who treats patients at Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine. “But a randomized trial published in 1999 showed that combining it with cisplatin chemotherapy improved survival outcomes.”

Even today, according to Schwarz, doctors have no way of knowing who will do well or poorly with the combined radiation and chemotherapy that every patient receives. Now, Schwarz and her colleagues have shown that the tumor’s response to chemotherapy, independent of radiation, may be a major deciding factor in whether a patient will do well with the standard treatment.

The study appears online in the journal Gynecologic Oncology.

“This is evidence that cisplatin is not just helping the radiation work better,” Schwarz said. “It is having some direct toxic effect on cancer cells that may be hiding elsewhere in the body, some place where the radiation is not hitting it, since we target the radiation so precisely to the main tumor. We think it would be beneficial for that drug to be selected appropriately for the patient’s individual tumor.”

The investigators tested tumors from 33 cervical cancer patients before their treatment began. They divided the patients’ tumors into three categories – responsive, intermediate response and nonresponsive – based on how well cisplatin killed the tumor cells growing in a dish.

For tumors categorized as responsive – those cancer cells that cisplatin killed most easily – 100 percent of the patients were alive and disease-free after two years. For those that showed an intermediate response, 83 percent of the patients were alive and disease-free after two years. And for those tumors deemed nonresponsive, only 58 percent of patients had two-year disease-free survival.

Cervical cancers can be divided into two main types based on how they look under a microscope – squamous cell carcinoma and adenocarcinoma. The nonresponsive number was even worse for patients diagnosed with the more common squamous cell carcinoma, with 46 percent disease-free survival at two years.

“Ideally, we would like to be able to design clinical trials for the nonresponsive patients,” Schwarz said. “One chemotherapy drug isn’t working for everyone, but there isn’t going to be one explanation for why the chemo doesn’t work. It’s going to be 50 different explanations, and figuring that out is the challenge.”

Schwarz is quick to point out the weaknesses of this study. In addition to the small number of patients, the lab test used was not ideal and should not be used to decide therapy for patients, she said. The investigators initially evaluated 75 tumors for chemotherapy response. And though some patients’ data was not included because they did not adhere to the treatment regimen, 31 patients were excluded from the analysis because their tumor cells did not grow well in the lab.

“This is definitely not the definitive test,” Schwarz said. “But I think our results should prompt investigators to think outside the box and start generating new ideas about how best to treat this disease. The bottom line is a one-size-fits-all treatment for each patient is going by the wayside. As we develop personalized strategies, this is the sort of testing that can guide it.”

Study: In vitro chemoresponse to cisplatin and outcomes in cervical cancer.

Source: Washington University in St. Louis

Alzheimer’s Markers Predict Start of Mental Decline

Scientists at Washington University School of Medicine in St. Louis have helped identify many of the biomarkers for Alzheimer’s disease that could potentially predict which patients will develop the disorder later in life. Now, studying spinal fluid samples and health data from 201 research participants at the Charles F. and Joanne Knight Alzheimer’s Disease Research Center, the researchers have shown the markers are accurate predictors of Alzheimer’s years before symptoms develop.

“We wanted to see if one marker was better than the other in predicting which of our participants would get cognitive impairment and when they would get it,” said Catherine Roe, PhD, research assistant professor of neurology. “We found no differences in the accuracy of the biomarkers.”

The study, supported in part by the National Institute on Aging, appears in Neurology.

The researchers evaluated markers such as the buildup of amyloid plaques in the brain, newly visible thanks to an imaging agent developed in the last decade; levels of various proteins in the cerebrospinal fluid, such as the amyloid fragments that are the principal ingredient of brain plaques; and the ratios of one protein to another in the cerebrospinal fluid, such as different forms of the brain cell structural protein tau.

The markers were studied in volunteers whose ages ranged from 45 to 88. On average, the data available on study participants spanned four years, with the longest recorded over 7.5 years.

The researchers found that all of the markers were equally good at identifying subjects who were likely to develop cognitive problems and at predicting how soon they would become noticeably impaired.

Next, the scientists paired the biomarkers data with demographic information, testing to see if sex, age, race, education and other factors could improve their predictions.

“Sex, age and race all helped to predict who would develop cognitive impairment,” Roe said. “Older participants, men and African Americans were more likely to become cognitively impaired than those who were younger, female and Caucasian.”

Roe described the findings as providing more evidence that scientists can detect Alzheimer’s disease years before memory loss and cognitive decline become apparent.

“We can better predict future cognitive impairment when we combine biomarkers with patient characteristics,” she said. “Knowing how accurate biomarkers are is important if we are going to some day be able to treat Alzheimer’s before symptoms and slow or prevent the disease.”

Clinical trials are already underway at Washington University and elsewhere to determine if treatments prior to symptoms can prevent or delay inherited forms of Alzheimer’s disease. Reliable biomarkers for Alzheimer’s should one day make it possible to test the most successful treatments in the much more common sporadic forms of Alzheimer’s.

Study: Amyloid imaging and CSF biomarkers in predicting cognitive impairment up to 7.5 years later

Source: EurekAlert!

Biomarker Progress Offers Hope for Early Autism Spectrum Disorder Detection

Autism spectrum disorders (ASD) are neurodevelopmental disorders typically characterized by difficulties in social interactions and delayed or abnormal language development. Although ASD reportedly affects 1 in 88 people in the United States, to date there have been no distinctive biomarkers to diagnose the disease. In a special themed issue of Disease Markers, investigators report on the current understanding of ASD genetics and the possibilities of translating genetic research toward biomarker development in ASD.

Decoding DNA Finds Breast Tumor Signatures that Predict Treatment Response

Decoding the DNA of patients with advanced breast cancer has allowed scientists to identify distinct cancer “signatures” that could help predict which women are most likely to benefit from estrogen-lowering therapy, while sparing others from unnecessary treatment.