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BioTime’s Subsidiary OncoCyte Corporation Publishes Data on the Gene FSIP1 as a Breast Cancer-Specific Marker

BioTime, Inc. (NYSE MKT: BTX) and BioTime’s subsidiary OncoCyte Corporation recently announced the publication of a scientific report on the gene FSIP1 and its potential as a marker for breast cancer. The paper, published in the peer-reviewed journal Biomarkers in Medicine and available online today, describes the microarray-based approach used to identify FSIP1 as a breast cancer biomarker with significantly elevated expression in breast tumors expressing the estrogen receptor, which represents 70-80% of all breast cancers. In addition to elevated gene expression, FSIP1 protein was also expressed within tumors at significant levels whereas little to no expression was found in most normal tissues, including healthy breast tissue. Combined, these findings lay the foundation for novel diagnostic and therapeutic strategies, including the measurement of FSIP1 in the blood as a screen for the presence of cancer, as well as targeting of FSIP1 as an antigen in cancer immunotherapy approaches.

Based on large unmet need, market size, and data generated thus far from patient sample screening, OncoCyte is initially focusing its efforts on identifying biomarkers that may be used to detect and monitor breast and bladder cancers. OncoCyte has been developing, characterizing, and manufacturing monoclonal antibodies for use in detecting breast cancer, in preparation for the initiation of the first clinical study of PanC-DxTM and is currently working with a select group of cancer researchers to finalize a study protocol for submission to the institutional review boards of the study sites. If clinical trials are successful, OncoCyte intends to launch PanC-DxTM as an in vitro diagnostic (IVD) in Europe before seeking FDA approval required to market PanC-DxTM in the United States.

Quest Diagnostics Introduces Comprehensive Opioid Therapy Genetic Test Based on CYP450 Biomarker License with Transgenomic

Quest Diagnostics (NYSE: DGX), the world’s leading provider of diagnostic information services, recently announced the availability of a new lab-developed genetic test to aid the delivery of personalized opioid pain-relieving treatment. It is believed to be the first clinical lab to offer testing for variants in all cytochrome P450 (CYP450) genes known to influence the CYP450 enzyme system, which affects metabolism of opioids and other medications.

C2N Diagnostics Announces Collaborative Research Agreement with Cambridge Isotopes

C2N Diagnostics (C2N) recently announced that it has signed a collaborative research and a global, exclusive supplier agreement with Cambridge Isotope Laboratories, Inc (CIL). The partnership guarantees C2N’s future access to mass quantities of highly enriched stable isotopes at predictable prices. These stable isotopes are key reagents to C2N’s platform of Stable Isotope Labeling Kinetic (SILK™)-based biomarkers. Such biomarkers are showing considerable promise to detect early Alzheimer’s pathology (i.e., well before the onset of clinical symptoms) as well as to measure treatment responsiveness in preclinical and clinical drug studies.

C2N gains a research partner in CIL that is the premier manufacturer in the world of stable isotopes used in clinical research and diagnostic applications. Under terms of the agreement, C2N receives from CIL an upfront payment, commercial milestone fees, future supply guarantees of stable isotopes at predictable prices, and large quantities of GMP-grade stable isotope (13C6) labeled leucine (L-Leucine). The L-Leucine will be used in future upcoming clinical validation studies involving C2N’s SILK™-based tests. CIL also commits to making significant investment in its own infrastructure and manufacturing processes. This will ensure CIL’s ability to meet the future demand of stable isotopes that will incorporate into C2N’s tests

“We spent considerable time evaluating the options available to C2N for obtaining access to stable isotopes used in our SILK™ tests. The logistics of having adequate supply of these reagents to enable disease screening on large numbers of at-risk individuals are far from trivial. We concluded that CIL is the best-positioned company in the world to meet our future expected demands in terms of both material quantity and material quality,” stated Dr. Joel B. Braunstein, C2N’s CEO. “Stable isotopes are non-radioactive, perfectly safe for people to consume and to the environment, and offer great sensitivity for tracking the in vivo metabolism of proteins implicated in diseases like Alzheimer’s. This makes them highly desirable diagnostic reagents. As we expand the use of our SILK™-based biomarkers beyond research services and into clinical diagnostic applications, CIL will be an instrumental partner to help us qualify our test kits and to produce L-Leucine under GMP scaled-up conditions.”

Dr. Joel Bradley, CIL’s CEO, commented, “By focusing on ways to diagnose and treat early Alzheimer’s disease, C2N is tackling one of the most important challenges in modern medicine. The company is making encouraging progress toward its ultimate goal of offering a convenient screening test for early Alzheimer’s that can be administered in the ambulatory setting. At CIL, we acknowledge the social and commercial impact of C2N’s efforts. For this reason, CIL is privileged and delighted to assist C2N with its development activities and to become C2N’s exclusive supplier of stable isotopes.”

Source: C2N Diagnostics

Abcodia and Cellmid Collaborate on the Studying of Midkine for Early Diagnosis of Colorectal Cancer

Abcodia Ltd, the UK biomarker validation company with a focus on early detection of cancer, today announced that it has entered into a collaboration agreement with Cellmid Ltd (ASX: CDY), for the testing of midkine (MK) in a collection of longitudinal serum samples using Cellmid’s MK-ELISA.

The initial objective of the collaboration is to validate midkine as a useful marker for the screening and early diagnosis of colorectal cancer. Serum samples will be provided by Abcodia and testing will be carried out by Cellmid.

The collaboration focuses on the assessment of midkine in pre-diagnosis serum samples. Abcodia has exclusive access to a unique biobank of 5,000,000 serum samples collected through the UK Collaborative Trial for Ovarian Cancer Screening.

The biobank was derived from 200,000 initially healthy volunteers. Since first recruitment, more than 27,000 individuals have been diagnosed with cancer. A subset of 50,000 individuals within the 200,000 cohort have provided samples annually, making this a unique longitudinal resource for testing midkine levels early, even before symptoms appear.

The collaboration agreement allows for the testing of multiple cancer indications, but initially targeting the early detection and screening of colorectal cancer. Colorectal cancer ranks third in incidence and second in cancer-related mortality in the United States.

Although the five year survival rate for stage 1 cancers is as high as 74%, for stage 4 cancers, when the cancer has metastasized, this reduces to just 6%. Early diagnosis of colorectal cancer, before the spread to the lymph nodes and distant sites, is vital to reduce death rates.

Midkine has been extensively validated as a biomarker in a range of other cancers. t has been shown to appear very early in some solid tumours with demonstrated utility in disease management and monitoring. Since 2012 midkine has been commercially used as one of the biomarkers in CxBladder®, a diagnostic test for the monitoring of bladder cancer patients.

Cellmid’s CEO, Maria Halasz, said: “We are excited to collaborate with the expert team at Abcodia to measure midkine levels in their extensive collection of pre-diagnosis serum samples. It is an exceptional opportunity for Cellmid to take part in the development of an important cancer diagnostic test.”

Abcodia’s CEO, Dr Julie Barnes, said: “I am delighted to be able to form this partnership with Cellmid. Midkine is an intriguing marker and I hope that we can reveal an interesting profile in the early pre-symptomatic phase of colorectal cancer. The uptake of current screening methods for colorectal cancer (colonoscopy and haemoccult testing) is low and a simple blood test could help significantly improve early diagnosis and therefore improve treatment outcomes.”

Source: Abcodia

Psychemedics Launches New Hair Alcohol Test

Psychemedics Corporation (NASDAQ: PMD), hair testing pioneer and global leader for over twenty-five years, announced the launch of its hair alcohol test – a test that measures average alcohol consumption over a period of approximately three months, indicates the level of alcohol use during that time period, and can provide a behavioral indication of excessive use.

Alcohol is the most abused substance in the world, and excessive use poses serious health and safety issues to society. In other regions of the world, this test has been used effectively in the courts, corporate alcohol screening programs, and in monitoring medical issues and probation compliance. Psychemedics’ new hair alcohol test provides answers about alcohol abuse and can be an indicator of those dependent on alcohol.

The test measures the amount of ethyl glucuronide (EtG) in the hair – a trace metabolite of ethanol and a direct alcohol biomarker – and follows the guidelines determined by the World Health Organization in association with the Society of Hair Testing for measuring consumption.

This non-invasive testing procedure uses a small sample of hair that is easily collected and shipped. All work is done by Psychemedics’ College of American Pathologists (CAP) and ISO/IEC 17025:2005 certified laboratory.

Advancing The Science Of Hair Testing

Psychemedics established its technological and market leadership position in 1987 with the development of the first hair test to detect drugs of abuse. Continued advancement in the science of hair testing is critical to Psychemedics, and this new alcohol test provides clients with another method to identify substance abuse.

Raymond C. Kubacki, Chairman and CEO stated, “We are excited to announce the availability of this new hair alcohol test. Our company has, for over twenty-five years, offered the most effective hair testing technology based upon scientifically validated drug testing methods. After many years of investing time and research into developing a hair alcohol test, we are proud to now provide the market with a reliable test to measure alcohol consumption over a period of time.”

Source: Psychemedics Corporation