Cancer Genetics: High-End Diagnostics For Personal Cancer Treatment

Original post, Bio-Wire (9/5/2013)

Editors' Note: This article covers a micro-cap stock. Please be aware of the risks associated with these stocks.

CGI: Overview

Cancer Genetics Inc. (NASDAQ: CGIX) is a rapidly growing genetics company that specializes in cancer diagnostics and the process of creating personalized cancer therapies for patients. The company's IP-protected products include proprietary FISH probes and a wide variety of CGH Microarrays that are designed to identify genetic mutations present in particular types of cancer cells.

The company is also developing next-generation DNA sequencing and offers diagnostic services from its headquarters in Rutherford, New Jersey. CGI clients include prestigious cancer centers like Memorial Sloan-Kettering, Mayo Clinic, the National Cancer Institute, Dana-Farber, Hackensack University Medical Center, The Cleveland Clinic and others.

CGIX Since IPO

Cancer Genetics announced its initial public offering of 600,000 shares priced at $10.00 apiece on April 4th, 2013, with the ticker "CGIX" on the OTC markets. The IPO was completed on April 10th, 2013, with a total of 690,000 shares sold (90,000 extra from overallotment). Proceeds from the IPO were $6.9 M prior to underwriting discounts and commissions. Shares of CGIX traded in the $7.00-17.00 range since April, and recently settled close to the $10.00 level after the recent 1.5 M share offering. CGIX was also uplisted to the NASDAQ on August 14th, 2013. (Source: MarketWatch)

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CGI: Financials

Recent uplisting to the NASDAQ, and the successful close of a 1.5 M share public offering (raising $15 M for the company) puts CGI at a much more comfortable position going forward.

Top-line growth for the company has been very strong, reflecting high demand for cancer diagnostics in recent years. In the first half of 2013, revenues were 54% higher than they were in the first half of 2012. Gross margins have also improved quite dramatically, reflecting the impact of higher sales.

The bulk of the company's revenue was derived from hospitals and clinics (including the names mentioned earlier), as well as insurance companies, Medicare and pharmaceutical companies. These revenues are generated from the sale of products used in clinical and research settings, and various services performed by the company's specialists.

The Role of Modern Cancer Diagnostics

Recent advances in biology have created a golden age for cancer research and development. FDA approvals for cancer drugs have surged in recent years, and institutional grants for cancer research are at an all-time high. Financial incentives have also encouraged a number of companies to pursue rare ("orphan") drug indications, many of which are cancer indications that were historically deemed "unattractive" by the pharmaceutical industry. Patients with late-stage disease have also done better due to an inflow of specialized drugs typically used after first and second line therapy.

In recent years there has also been an enormous effort to improve patient outcomes with early detection. It is often the case that a cancerous growth will start off simpler (and in a smaller area) and with fewer mutations in the tumor cells. If left untreated, malignant cells can breach membranes and spread to other areas of the body - sometimes developing new, harmful mutations in the process. Because of the progressive nature of the disease, early detection is usually the best weapon.

Until recent advancements in diagnostic technology, biopsies of malignant tissue would be examined under a microscope by a pathology lab in an attempt to predict the course of the disease. We now have very powerful tests that can not only identify the presence of important proteins in malignant tissue, but monitor the expression of specific oncogenes by cancer cells. To do this, mRNA is isolated from the cells and introduced to something known as a DNA microarray. This device maps the activity level of genes, and produces a simple color-coded map that allows researchers and physicians to interpret genomic activity of cancer cells on a very fundamental level.

Knowing more details about the genotype of a patient's malignancy allows physicians to employ highly personalized therapeutic regimens, which target the vulnerabilities of malignant cells much more effectively. With this we can also determine the course of each patient's malignancy more accurately, which allows oncologists to adjust the intensity of damaging treatments like chemotherapy.

Advanced cancer diagnostics will also reduce our current reliance on outdated phenotypic analysis of malignancies, which are less accurate and much more time intensive. In coming years, widespread adoption of new diagnostics is not only expected to improve patient survival rates, but to reduce the overall costs of cancer treatment.

CGI: Diagnostics Pipeline

Cancer Genetics produced two main kinds of diagnostic tools - fluorescent in situ hybridization ((FISH)) probes, and comparative genomic hybridization (CGH) arrays.

Fluorescent in situ hybridization

FISH is based on older technology that can identify and bind onto the location of certain DNA sequences on individual chromosomes. Fluorescent molecules are attached to the probes to reveal their exact location during analysis. When used clinically, FISH probes can quickly identify specific chromosomal abnormalities that are associated with certain cancers and other genetic disorders.

CGI developed and patented FISH probes for eight major types of hemotologic malignancies: Anaplastic Large Cell Lymphoma (ALCL), Acute Lymphoblastic Leukemia (ALL), Acute Myeloid Leukemia (AML), Chronic Lymphocytic Leukemia (CML), Multiple Myeloma (MM), Myelodysplastic Syndromes (MDS) and Non-Hodgkin Lymphoma (NHL).

Four other FISH probes were developed for breast, cervical, colorectal and lung solid tumors. CGI also developed a novel probe for cervical cancer called FHACT, which looks for four specific chromosomal aberrations associated with Human Papillomavirus (HPV) and cervical cancer.

The FISH probes are manufactured outside of the US and distributed in Europe under CE marking, although the FISH probe portfolio is only cleared for use in research labs in the United States.

Comparative Genomic Hybridization (CGH) Arrays

CGH arrays are based on the fluorescent marking technique used with FISH probes, although they are much more sophisticated. Note that CGH arrays are not DNA microarrays because they specifically track the gain and loss of genetic material in a test sample of DNA relative to a reference sample. This allows for more accurate, in-depth analysis of the genotypic differences between the DNA of a tumor cell and healthy cell DNA.

CGI currently markets three CGH arrays which provide a highly detailed diagnostic profile for three types of blood cancers: Chronic Lymphocytic Leukemia (CLL), Diffuse Large B-Cell Lymphoma (DLBCL), and Mantle Cell Lymphoma (MCL). The company also markets a test specifically designed to classify kidney cancers into one of three subtypes - clear cell, papillary and chromophobe renal cell carcinoma (RCC).

Recently presented data from a 322 specimen study performed by Dr. Kanti Rai and Dr. Nicholas Chiorazzi at North Shore LIJ showed that the Cancer Genetics MatBA® test for Chronic Lymphocytic Leukemia (and Small Lymphocytic Leukemia) was able to identify genomic abnormalities associated with "unfavorable" CLL/SLL outcomes that were missed by FISH probes (8% of total specimens). The CGH array was also able to differentiate between "favorable" and "intermediate" outcomes with statistical significance. In a clinical setting this would allow an oncologist to adjust a patient's therapy in accordance with his or her expected outcome.

Source: Cancer Genetics Inc.

Next-Generation DNA Sequencing

Cancer Genetics' technology pipeline includes DNA sequencing technology which would allow for genomic maps that display individual base pairs. These maps would allow geneticists to "see" a genotype with 1000x the resolution of DNA Microarrays, which paves the way for even more sophisticated interpretation of cancer cell genotypes and their likely outcomes.

Opportunity in Cancer Diagnostics

Although the cost of cancer diagnostics pale in comparison to the cost of novel therapies, genetic assays are being used more frequently due to their usefulness. Pharmacoeconomic benefit has also supported strong and growing demand for new and high-end tests.

Cancer Genetics is on track to process around 10,000 tests by the end of 2013, which should produce revenues of roughly $6 M for fiscal year 2013. Expected improvements in manufacturing efficiency should also improve the company's margins.

CGIX, at a market capitalization of $57 M at time of writing, is valued at approximately 10x its revenues. This is inexpensive if you factor in the company's trailing rate of sales growth, which has been faster than the industry average.

The company's CGH diagnostic products target blood and kidney cancer indications, which are currently more attractive than crowded indications like breast cancer.

Based on US statistics for blood cancers and costs for diagnostic products and servicing, about 40,000 newly diagnosed patients creates ~$40-50 M in opportunity for MatBA® in currently targeted indications. More potential is found in ex-US markets and in cancer patients that already have a diagnosis. The figure grows dramatically after including the market potential of other hematologic indications. In the US alone, the market opportunity for the newly diagnosed approaches $200 M.

UroGenRA for renal cell carcinoma classification also has huge potential and a ~$60 M opportunity on currently targeting indications. This figure grows dramatically when factoring in potential use in bladder and prostate cancers, which would bring the market size closer to $400 M.

The novel FISH probe for HPV mutation, FHACT , has an approximate $10 M US opportunity while targeting cervical cancer, although this could expand significantly with use in endometrial and ovarian cancers. $80 M is realistic given incidence of HPV-induced cancer.

Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it. I have no business relationship with any company whose stock is mentioned in this article. (More...)

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Is there a place for personal values in leadership?

Margaret Hodge MP accused Google of being "devious, calculated and, in my view, unethical”. Photograph: Andrew Winning/REUTERS

In the banking sector, standards have been widely condemned in the wake of the global economic crisis. This year, corporate values were in the spotlight again when Google was accused by Margaret Hodge MP of being "devious, calculated and, in my view, unethical".

To be successful in the cut-throat world of business, you may think there's no place for soft values and morals. But holding on to personal principles as a leader is not just about ethics – it can also boost your career and organisation.

Being true to your values helps performance in the long term, according to Petra Wilton, of the Chartered Management Institute. "Not only does it have consequences for reputation and trust in business, it also has a huge impact through employee engagement, productivity and outcomes."

"Too often people's personal principles go out of the window when they take up leadership positions, when they've got the pressures of targets and bad examples to follow. You can certainly behave unethically and still get good business results in the short term, but it's likely to come back and bite you at the end of the day."

With an increased focus on corporate responsibility since the banking crisis, many companies have made efforts to embrace an ethical culture among employees. But, although company values may provide a useful framework, the ethics of an organisation are ultimately set by the example of its leaders.

"It's what you're doing, not what you're saying, that people will use as an example," says Philippa Foster Back, director of the Institute of Business Ethics. "People recognise that to get on they maybe need to behave like their boss. So the culture of the organisation is set by the top."

If sticking to your principles seems like an obvious objective, why do so many leaders seem to get it wrong?

Petra Wilton suggests: "Most people don't get up and say: 'I'm an unethical individual, I'm going to go and make the wrong decisions'. A lot of the time it happens when people try to meet the corporate and business objectives without having any real measure of the human consequences."

One of the main problems for business leaders is subjectivity – there are no clear cut rules on ethics. "The meaning of ethics changes from person to person," explains Sankalp Chaturvedi, associate professor at the Imperial College Business School.

"What is ethical to me may not be ethical to you. And business processes themselves are very contextual – what is ethical in one country may not be in another."

It's easy to see how principles may not always translate to other people. For instance, Starbucks has been ranked in the world's most ethical companies for six years in a row. Yet its tax avoidance methods have sparked protests and criticism.

Given the ambiguity of ethics, your personal principles may not be shared by everyone. So for leaders, valuing principles must be about honesty and having an open conversation. Chaturvedi says: "Problems happen when people are not authentic – when they say one thing and do something else – so it's about being consistent about what you're saying.

"Being a leader is not just about making decisions, but also making sure people understand what the intention is behind it."

But balancing business and principles is not always easy: challenging decisions can require compromises. "There will always be ethical dilemmas where it's hard to weigh up the consequences of a decision you are making," says Wilton.

"Sometimes there's no clear right or wrong answer. But valuing your principles is about considering the implications of what you're doing and, when in doubt, challenge things where possible."

Back adds: "It comes back to the choices that individuals make, and what they feel comfortable with. What's important is having a mental checklist while you're making decisions and being open about things you're not comfortable with. True leadership is having the courage to say no."

Ethics are not just important for the sake of companies, but also for the leaders themselves. Back says: "If you're not true to your values then you're likely to end up with stress and unease as you have to take on a different persona as you walk in through the door at work. So it is very important for individuals."

And holding on to principles can help guide you through your career. Steve Nicholls, who coaches executives and managers, says that as you climb up the career ladder into more senior roles, there is often less in terms of peers and reality checks.

"It's important to hang on to personal values because, as a leader, there may not be anyone who you see as a peer to put an arm around your shoulder. One of the most difficult things as a leader is the management of ambiguity in business contexts. Yet you need to do this alongside having clear communications."

"At the end of the day, leaders have got to lead and they've got to be strong."

Chaturvedi adds: "Research has shown consistently that culture has an impact on performance in a company. If people share values consistently then there's a strong culture – and that is definitely going to have an impact on the performance of the individual, as well as the company."

This content is brought to you by Guardian Professional. To get more content and advice like this direct to your inbox, sign up for our weekly update and careers ebook.

View the original article here

Is there a place for personal values in leadership?

Margaret Hodge MP accused Google of being "devious, calculated and, in my view, unethical”. Photograph: Andrew Winning/REUTERS

In the banking sector, standards have been widely condemned in the wake of the global economic crisis. This year, corporate values were in the spotlight again when Google was accused by Margaret Hodge MP of being "devious, calculated and, in my view, unethical".

To be successful in the cut-throat world of business, you may think there's no place for soft values and morals. But holding on to personal principles as a leader is not just about ethics – it can also boost your career and organisation.

Being true to your values helps performance in the long term, according to Petra Wilton, of the Chartered Management Institute. "Not only does it have consequences for reputation and trust in business, it also has a huge impact through employee engagement, productivity and outcomes."

"Too often people's personal principles go out of the window when they take up leadership positions, when they've got the pressures of targets and bad examples to follow. You can certainly behave unethically and still get good business results in the short term, but it's likely to come back and bite you at the end of the day."

With an increased focus on corporate responsibility since the banking crisis, many companies have made efforts to embrace an ethical culture among employees. But, although company values may provide a useful framework, the ethics of an organisation are ultimately set by the example of its leaders.

"It's what you're doing, not what you're saying, that people will use as an example," says Philippa Foster Back, director of the Institute of Business Ethics. "People recognise that to get on they maybe need to behave like their boss. So the culture of the organisation is set by the top."

If sticking to your principles seems like an obvious objective, why do so many leaders seem to get it wrong?

Petra Wilton suggests: "Most people don't get up and say: 'I'm an unethical individual, I'm going to go and make the wrong decisions'. A lot of the time it happens when people try to meet the corporate and business objectives without having any real measure of the human consequences."

One of the main problems for business leaders is subjectivity – there are no clear cut rules on ethics. "The meaning of ethics changes from person to person," explains Sankalp Chaturvedi, associate professor at the Imperial College Business School.

"What is ethical to me may not be ethical to you. And business processes themselves are very contextual – what is ethical in one country may not be in another."

It's easy to see how principles may not always translate to other people. For instance, Starbucks has been ranked in the world's most ethical companies for six years in a row. Yet its tax avoidance methods have sparked protests and criticism.

Given the ambiguity of ethics, your personal principles may not be shared by everyone. So for leaders, valuing principles must be about honesty and having an open conversation. Chaturvedi says: "Problems happen when people are not authentic – when they say one thing and do something else – so it's about being consistent about what you're saying.

"Being a leader is not just about making decisions, but also making sure people understand what the intention is behind it."

But balancing business and principles is not always easy: challenging decisions can require compromises. "There will always be ethical dilemmas where it's hard to weigh up the consequences of a decision you are making," says Wilton.

"Sometimes there's no clear right or wrong answer. But valuing your principles is about considering the implications of what you're doing and, when in doubt, challenge things where possible."

Back adds: "It comes back to the choices that individuals make, and what they feel comfortable with. What's important is having a mental checklist while you're making decisions and being open about things you're not comfortable with. True leadership is having the courage to say no."

Ethics are not just important for the sake of companies, but also for the leaders themselves. Back says: "If you're not true to your values then you're likely to end up with stress and unease as you have to take on a different persona as you walk in through the door at work. So it is very important for individuals."

And holding on to principles can help guide you through your career. Steve Nicholls, who coaches executives and managers, says that as you climb up the career ladder into more senior roles, there is often less in terms of peers and reality checks.

"It's important to hang on to personal values because, as a leader, there may not be anyone who you see as a peer to put an arm around your shoulder. One of the most difficult things as a leader is the management of ambiguity in business contexts. Yet you need to do this alongside having clear communications."

"At the end of the day, leaders have got to lead and they've got to be strong."

Chaturvedi adds: "Research has shown consistently that culture has an impact on performance in a company. If people share values consistently then there's a strong culture – and that is definitely going to have an impact on the performance of the individual, as well as the company."

This content is brought to you by Guardian Professional. To get more content and advice like this direct to your inbox, sign up for our weekly update and careers ebook.

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Personal website chronicling improves depressive symptoms in women with breast cancer

Main Category: Breast Cancer
Also Included In: IT / Internet / E-mail;  Depression
Article Date: 14 Aug 2013 - 2:00 PDT
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Personal website chronicling improves depressive symptoms in women with breast cancer

Adults increasingly are conveying their personal experience with serious disease online, but do such chronicles help the authors or their audience? In the first known study of its kind, UCLA researchers have discovered that creating a personal website to chronicle the cancer experience and communicate with the author's interpersonal circle can reduce depressive symptoms, increase positive mood, and enhance appreciation for life in women diagnosed with breast cancer. Published online ahead of print in the Journal of Clinical Oncology, the study was led by Annette Stanton, member of the Jonsson Comprehensive Cancer Center and professor of psychology and psychiatry/biobehavioral sciences.

Explaining the impetus for the study, Stanton said, "From our own and others' previous research, we know that expressing emotions surrounding the experience and gaining social support can be helpful for people diagnosed with cancer, and we know that interpersonal interventions can be useful." However, most interpersonal interventions to promote quality of life in adults diagnosed with cancer involve the patient's partner, primary caregiver, or other cancer patients. "Our goal in this research was to provide a platform on which breast cancer survivors could reflect on their experiences, as well as communicate with and leverage support from their existing social networks, especially friends and family," Stanton said. "The idea for this trial really took off when I met two sisters who had created personal websites for each other when each was diagnosed with cancer."

In Project Connect Online (PCO), a randomized trial conducted with 88 breast cancer survivors, Stanton and colleagues led three-hour workshops in which women created personal websites. Women randomly assigned to the control group were offered the workshop six months later. All participants completed standard measures of psychological status before being assigned to their respective groups and six months after selection.

In the PCO workshops conducted with small groups, women learned about potential uses of the websites, such as expressing emotions related to cancer, providing medical status updates, and letting others know what would be helpful. Women also proactively considered common concerns of website authors, including the pressure to be positive or eloquent. They then engaged in hands-on website creation and at the end of the three-hour sessions had created their websites and authored their first posts. According to Stanton, "We worked closely with a website developer so participants had several choices for how their sites looked, but all sites had the same functions. It was inspiring to see women of so wide an age range (28 to 76 years old) and of such varied computer experience develop their websites in just a few hours."

The women assigned to PCO found their websites particularly valuable for telling the stories of their cancer experiences, expressing emotions, and reducing how much information they had to repeat for family and friends. Visitors to the websites found them useful for providing updates on the authors' health and for helping visitors feel emotionally close to authors. The women in PCO demonstrated statistically significant improvement in depressive symptoms, positive mood, and life appreciation. The effects were particularly strong for women in active medical treatment, most of whom had advanced (metastatic) disease. Women are more often motivated to tell their stories, express cancer-related emotions, garner support, and keep others informed during active medical treatment and the often unpredictable course of metastatic disease than those who have completed their medical treatments for cancer. "We are encouraged by these positive findings," Stanton said, "especially for cancer survivors with the most need, those in active medical treatment or with more advanced disease. Our next step is to gain support for a larger test of Project Connect Online."

Article adapted by Medical News Today from original press release. Click 'references' tab above for source.
Visit our breast cancer section for the latest news on this subject.

Project Connect Online: Randomized Trial of an Internet-Based Program to Chronicle the Cancer Experience and Facilitate Communication, Annette L. Stanton, Elizabeth H. Thompson, Catherine M. Crespi, John S. Link and James R. Waisman, Journal of Clinical Oncology, Published online before print August 12, 2013, doi: 10.1200/JCO.2012.46.9015

This research was supported by the Susan G. Komen for the Cure Foundation, the Breast Cancer Research Foundation and the National Institutes of Health.

UCLA's Jonsson Comprehensive Cancer Center

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