Featured Research

from universities, journals, and other organizations

Article addresses report on genome-based therapeutics, companion diagnostics

Date:
February 12, 2014
Source:
University of Vermont
Summary:
The promise of personalized medicine is the ability to tailor therapy to the patient's genome and their cancer's genome using a series of tests, but the system guiding the development of those tests is complex, and plagued with challenges.

The promise of personalized medicine, says University of Vermont (UVM) molecular pathologist Debra Leonard, M.D., Ph.D., is the ability to tailor therapy based on markers in the patient's genome and, in the case of cancer, in the cancer's genome. Making this determination depends on not one, but several genetic tests, but the system guiding the development of those tests is complex, and plagued with challenges.

Related Articles


In a February 12, 2014 Online First Journal of the American Medical Association "Viewpoint" article, Leonard and colleagues address this issue in conjunction with the concurrent release of an Institute of Medicine (IOM) Workshop Summary Report on "Co-Development of Genome-Based Therapeutics and Companion Diagnostic Tests." A professor and chair of pathology at UVM and Fletcher Allen Health Care, Leonard serves as a representative of the American College of Pathologists on the IOM's committee on Translating Genomic-Based Research for Health, which organized the workshop and authored the report.

"Whenever a drug is developed that will target a pathway underlying disease, you need a test that says the patient will benefit," explains Leonard. "The development of companion diagnostic tests to determine if a patient will respond to a specific drug is very complex and needs to be changed, but will require changes from many stakeholders, including test developers, pharmaceutical companies, the Food and Drug Administration, the Centers for Medicare and Medicaid Services, and other payers."

The concept of what is called the FDA's "Companion Diagnostic Pathway," explains Leonard, allows for assessment of the test to predict a drug's benefit, within the same clinical drug trial to assess the new drug's effectiveness as a treatment. Cancer specialists are the primary users of these types of drugs and tests.

In their "Viewpoint" article, Leonard and colleagues Robert McCormack, Ph.D., and Joanne Armstrong, M.D., M.P.H., who represent the testing and medical insurance industry respectively, argue for stakeholders' support of "a strategy to co-develop and co-submit to the FDA a diagnostic test (companion diagnostic [CoDx]) that specifically targets a drug to patients predicted to respond." The authors share that "regulatory and business challenges . . . hamper the broader field of diagnostic testing" and not just the companion diagnostic pathway.

Currently, there are two pathways for test co-development -- the FDA's in vitro diagnostic (IVD) tests and laboratory-developed tests (LDTs). Each has its own set of regulations and safety measures, as well as costs and insurance reimbursement eligibility. "The coexistence of two test development pathways is problematic, especially for co-developed CoDx tests, and requires clarification," writes Leonard and colleagues.

As an example of the current co-development CoDx environment, Leonard provides a potential scenario of a lung cancer patient for whom an oncologist may be considering several different drugs for treatment. "The pathologist has to do multiple separate CoDx tests, unless the institution does its own LDT that combines all the individual tests into a single test," Leonard explains, which is done in some pathology laboratories, predominantly using next-generation genetic sequencing. This combined test reduces the number of tests required, can conserve tissue and produce more medically-relevant results. However, insurance payers will not always cover the breadth of the tests.

"A university-based lab can run a single test to assess 28 genes, but an insurance company might only cover three of the gene tests," she admits.

The "Viewpoint" article addresses reimbursement and other economic obstacles, such as the investment environment for CoDx co-development and the costs associated with performing laboratory tests. The IOM Roundtable workshop explored these challenges, as well as discussed solutions to the companion diagnostic test co-development process.

"The goal was agreement on a unified plan, with every player doing their part," says Leonard, adding that "This issue needs thinking outside the box, with the patients at the center of the discussion."


Story Source:

The above story is based on materials provided by University of Vermont. The original article was written by Jennifer Nachbur. Note: Materials may be edited for content and length.


Journal Reference:

  1. Robert T. McCormack, Joanne Armstrong, Debra Leonard. Codevelopment of Genome-Based Therapeutics and Companion Diagnostics. JAMA, 2014; DOI: 10.1001/jama.2014.1508

Cite This Page:

University of Vermont. "Article addresses report on genome-based therapeutics, companion diagnostics." ScienceDaily. ScienceDaily, 12 February 2014. <www.sciencedaily.com/releases/2014/02/140212153248.htm>.
University of Vermont. (2014, February 12). Article addresses report on genome-based therapeutics, companion diagnostics. ScienceDaily. Retrieved December 20, 2014 from www.sciencedaily.com/releases/2014/02/140212153248.htm
University of Vermont. "Article addresses report on genome-based therapeutics, companion diagnostics." ScienceDaily. www.sciencedaily.com/releases/2014/02/140212153248.htm (accessed December 20, 2014).

Share This


More From ScienceDaily



More Health & Medicine News

Saturday, December 20, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

The Best Tips to Curb Holiday Carbs

The Best Tips to Curb Holiday Carbs

Buzz60 (Dec. 19, 2014) It's hard to resist those delicious but fattening carbs we all crave during the winter months, but there are some ways to stay satisfied without consuming the extra calories. Vanessa Freeman (@VanessaFreeTV) has the details. Video provided by Buzz60
Powered by NewsLook.com
Sierra Leone Bikers Spread the Message to Fight Ebola

Sierra Leone Bikers Spread the Message to Fight Ebola

AFP (Dec. 19, 2014) More than 100 motorcyclists hit the road to spread awareness messages about Ebola. Nearly 7,000 people have now died from the virus, almost all of them in west Africa, according to the World Health Organization. Video provided by AFP
Powered by NewsLook.com
Researchers Test Colombian Village With High Alzheimer's Rates

Researchers Test Colombian Village With High Alzheimer's Rates

AFP (Dec. 19, 2014) In Yarumal, a village in N. Colombia, Alzheimer's has ravaged a disproportionately large number of families. A genetic "curse" that may pave the way for research on how to treat the disease that claims a new victim every four seconds. Duration: 02:42 Video provided by AFP
Powered by NewsLook.com
Double-Amputee Becomes First To Move Two Prosthetic Arms With His Mind

Double-Amputee Becomes First To Move Two Prosthetic Arms With His Mind

Buzz60 (Dec. 19, 2014) A double-amputee makes history by becoming the first person to wear and operate two prosthetic arms using only his mind. Jen Markham has the story. Video provided by Buzz60
Powered by NewsLook.com

Search ScienceDaily

Number of stories in archives: 140,361

Find with keyword(s):
Enter a keyword or phrase to search ScienceDaily for related topics and research stories.

Save/Print:
Share:

Breaking News:

Strange & Offbeat Stories


Health & Medicine

Mind & Brain

Living & Well

In Other News

... from NewsDaily.com

Science News

Health News

Environment News

Technology News



Save/Print:
Share:

Free Subscriptions


Get the latest science news with ScienceDaily's free email newsletters, updated daily and weekly. Or view hourly updated newsfeeds in your RSS reader:

Get Social & Mobile


Keep up to date with the latest news from ScienceDaily via social networks and mobile apps:

Have Feedback?


Tell us what you think of ScienceDaily -- we welcome both positive and negative comments. Have any problems using the site? Questions?
Mobile: iPhone Android Web
Follow: Facebook Twitter Google+
Subscribe: RSS Feeds Email Newsletters
Latest Headlines Health & Medicine Mind & Brain Space & Time Matter & Energy Computers & Math Plants & Animals Earth & Climate Fossils & Ruins