diagnostics


Biosampling Basics with Scott Jewell, Van Andel Institute

Guest:

Scott Jewell, Senior Scientific Investigator and Director of Program for Biospecimen Science, Van Andel Institute Bio and Contact Info

Listen (3:30) Do you see more creativity in the sample consent area?

Listen (7:08) Sample collection - the operating room

Listen (6:52) Sample storage - keeping analytes viable

Listen (7:49) Are researchers becoming more discriminating in their choice of samples?

Listen (4:39) A gold mine

Listen (3:21) How did you get into this?

Scott Jewell joins us from the Van Andel Institute today to walk through some of the basic issues involved with the procurement, storage, and processing of biosamples.

This is the second part of our series on biospecimens, and Scott too will leave you wondering if more focus on sampling might just improve your research dramatically. Scott argues that as biomedical research has developed, "we’ve cherry picked the best things potentially out of what we could gain from science that were robust and that didn’t need to have the perfectly preserved samples.” But those days are passing and now there’s “a lot that doesn’t stand up because there are not appropriate measurements.”

It’s an overlooked area that could well offer a gold mine of solutions for biomedical research.

Podcast brought to you by: Quintiles - bringing people and knowledge together for a healthier world.

And by: Fluidigm - Make your biobank a quality research partner. Download the Evolution of Biobanking whitepaper today.

Raising the Standards of Biomarker Development - A New Series

We talk a lot on this show about the potential of personalized medicine. Never before have we learned at such breakneck speed just how our bodies function. The pace of biological research staggers the mind and hints at a time when we will “crack the code” of the system that is homo sapiens, going from picking the low hanging fruit to a more rational approach. The high tech world has put at the fingertips of biologists just the tools to do it. There is plenty of compute, plenty of storage available to untangle, or decipher the human body. Yet still, we talk of potential.

Protecting Reimbursement Top Priority in 2014, Says Jim Greenwood of BIO

Guest:

Jim Greenwood, CEO of BIO

Bio and Contact Info

Listen (2:49) 2013 - the year the IPO window opened

Listen (6:02) What has been your primary concern this year?

Listen (6:00) How can we raise the value of diagnostics?

Listen (7:44) Is there still broad bipartisan support for the NIH?

Listen (5:18) Protecting reimbursement tops the list in 2014

At the end of each year we do a program where we look back over the year and forward to the next. We're very pleased to have Jim Greenwood, the CEO of BIO, the national trade organization for our industry, here to do this show.

As the CEO of BIO, Jim represents the life science industry in Washington. Back in the Clinton and George W. Bush administrations, Jim learned the political ropes as a congressman from Pennsylvania. He's been a member of an ever declining species--a Rockefeller Republican. Jim's centrist political views no doubt make him a great choice to represent an industry which doesn't fall neatly along political lines. This past year he's fought for protecting drug and diagnostic reimbursement and lobbied against GMO labeling. When it comes to the sequester he admits there wasn't much anyone could do as the cuts affected every department in government. He says that the NIH budget should steadily increase but sounds doubtful that we'll see the kind of increase that happened when the human genome was sequenced.

Has the IPO boom in 2013 been a long overdue window, or a bubble? How can we raise the value of diagnostics? And what is his top priority in 2014? Jim openly shares his thoughts on these questions and more in today's interview.

Podcast brought to you by: Chempetitive Group - "We love science. We love marketing. We love the idea of combining the two to make great things happen for your marketing communications."

FDA Crackdown on 23andMe Delays a Revolution in Medicine, Says Medical Geneticist, Gholson Lyon

Guest:

Gholson Lyon, Assist. Professor, Coldspring Harbor

Bio and Contact Info

Listen (3:39) Why are you a fan of 23andMe?

Listen (4:58) What about the quality?

Listen (1:13) PGP limited in participation compared to 23andMe

Listen (11:45) Are you against regulation of CoDx or Rx?

Listen (4:29) Delaying the revolution

Listen (2:25) How do you envision the revolution?

About a week ago we featured a regulatory expert on the program explaining why the FDA's letter telling 23andMe to stop selling their PGS test is a good thing. Today we feature an outspoken fan of the DTC company, Gholson Lyon, medical geneticist at Cold Spring Harbor Laboratory.

Gholson is himself a happy customer of 23andMe, and says he's found the service invaluable. In 2011, Gholson led a team in the identification of a new rare genetic disease, Ogden Syndrome, which caused the death of a four month old Utah boy. At the time, Gholson did genetic tests on the boy's family, but was unable to return their results because the tests were not done in a CLIA laboratory. This led Gholson to become an advocate for doing genetic tests for research in a CLIA facility so that results might be returned to patients. Since the 23andMe service is done in a CLIA approved lab, Gholson found the company an excellent place to do genome wide testing.

But is CLIA regulation--which guarantees analytic validity--good enough for the kind of disease risk reports put out by 23andMe to their more than 500,000 customers? Gholson says yes. And regulating the tests further will cut out an important part of a new revolution in medicine.

Gholson acknowledges the diagnostics industry is attempting to bring up the quality of genetic tests, but says that industry companies are producing one-off tests done without the broader context of the genome. This is why he likes the 23andMe service.

"If you don't sequence or genotype the rest of there person's genome, then you have no knowledge about their ancestry and what population they come from. And so you really cannot predict the expression of a particular mutation in that person," he says in the interview.

Gholson also points out that by being a DTC company, 23andMe has been able to recruit many many more participants and data sets than a non-profit, such as the Personal Genome Project, of which he's also a member.

Just how far does Gholson go in his stance against regulation? And how does he envision this revolution in medicine?

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Regulation Expert, Mya Thomae, Weighs In on FDA Letter to 23andMe

Guest:

Mya Thomae, Founder, CEO, Myraqa

Bio and Contact Info

Listen (3:10) This letter more specific than in the past

Listen (2:51) What did 23andMe file with the FDA in 2012?

Listen (4:57) Are genetic tests medical devices?

Listen (4:36) Going the regulatory route good for business and patients

Listen (6:02) What about freedom of information?

Listen (1:53) How are 23andMe results different from risk assessments using standard epidemiology?

Listen (5:34) Does the letter signal a more assertive FDA?

Listen (1:05) Why has 23andMe not stopped selling the product?

On Monday, November 25th, the FDA sent a letter to the direct-to-consumer genetic testing company, 23andMe. The letter has received a bit more attention than the average FDA correspondence. The letter was addressed to 23andMe CEO, Anne Wojcicki, and told her that the company’s Personal Genome Service was in violation of the Federal Food, Drug and Cosmetic Act. The FDA requested that the company “immediately discontinue marketing” the test until it receives authorization.

Since the letter came out, there has been much discussion in the life science industry and with the public at large. Some say the letter reveals an over reaching, paternalistic government agency trying to hold back the inevitable, while others see the opportunity for a turning point for a diagnostics industry.

Mya Thomae has been helping companies comply with FDA regulations for 20 years. Mya is intimate with how the FDA works and laments that the diagnostics industry, as opposed to the regulated therapeutics industry, has been on a "race to the bottom." She doesn't hesitate when asked whether the 23andMe test is a medical device.

"Genetic tests are certainly medical devices, and there's numerous examples of different types of genetic tests moving their way through FDA," she says.

The problem with 23andMe, Mya asserts, is that they "haven't done the hard core clinical trials to show that their algorithms do indeed work as they say." And she finds it unfair that 23andMe can keep selling their tests while at the same time some companies are doing the trials, are working with the FDA, and are putting in the time and effort to develop quality tests.

Speaking of the 23andMe website, Mya points out hat the results are constantly changing based on the latest research paper that has just come out.

"Some folks have referred to it as results roulette," she says.

Should 23andMe be treated different from her clients who are pursuing regulation?

"I think 23andMe is different, but I think it's different in the way that makes it a research project as opposed to a product that should be giving clinical results to patients," she says.

What about our right to obtain our own genetic information? And how are the 23andMe results different from checking your risk factor for heart disease against the Framingham studies at the NIH website?
Mya addresses these and other concerns which have risen in the media since the letter was published. She also explains that regulation will be good for business as well as patients.

Is the letter any different from previous FDA letters, and does it signal a more assertive FDA when it comes to LDTs? Mya says she's lost some bets already on when the FDA will regulate LDTs, but she does see a shift happening. At the end of the interview she refers to some final guidance the FDA issued on RUO (research use only) kits the same day the letter to 23andMe was posted. RUO kits and reagents are not allowed for use with diagnostic tests that are approved by the FDA.

We end with the question, why hasn't 23andMe stopped selling the product?

Editor's Note: On Dec 5, 2013 23andMe discontinued selling any health related reports in compliance with the FDA's request.

Podcast brought to you by: See your company name here. - Promote your organization by aligning it with today's latest trends.

Dx from the Payer's Perspective with Ira Klein, Aetna

Podcast brought to you by the upcoming Personalized Medicine World Conference taking place in Mountain View, CA, January 28-29. Over 100 speakers in three tracks will discuss how best to navigate the changing landscape of personalized medicine.

Guest:

Ira Klein, MD, Chief of Staff, Office of the Chief Medical Officer, AETNA Bio and Contact Info

Listen (8:55) How do you determine when to pay for a Dx?

Listen (3:45) Are you opposed to covering a test before FDA approval?

Listen (2:56) How do you help physicians keep up with new Dx technology?

Listen (8:43) The problem of misaligned incentives

Listen (4:19) Are diagnostics way undervalued?

Our last show in the series, Commercializing Diagnostics, is from the payer's viewpoint. Reimbursement has become the biggest challenge for Dx companies, so we ask Ira Klein from Aetna to talk about the issues: How does Aetna go about deciding whether to cover a diagnostic? Do they always wait and follow the FDA's lead? What about the unregulated LDT's out there such as CardioDx's CAD test? Formerly a physician himself, Dr. Klein takes us into his world and explores the issues he faces as medicine changes. A fan of the new healthcare law, Klein sees diagnostics and personalized medicine as having a positive impact on the challenges of escalating costs and an aging population. Are diagnostics way undervalued, as Roche's Walter Koch asserted on the program? Tune in for Ira's answer.

It's All About the Patients: Mara Aspinall, CEO, Ventana

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Guest:

Mara Aspinall, CEO, Ventana Bio and Contact Info

Listen (4:37) How's Tucson?

Listen (3:36) Mission at Ventana entirely devoted to cancer

Listen (2:21) Digital pathology

Listen (2:29) What has made you a successful CEO?

Listen (1:15) It's all about the patients

Listen (1:21) A business person leading scientists

Listen (1:35) What inspires you about Roche?

Listen (3:49) Challenge of being a new CEO

Listen (1:26) Industry's failure with cancer

Listen (8:24) Leadership style

Listen (3:58) Challenge for personalized medicine

Listen (4:47) An early voice for personalized medicine

Listen (2:10) Personal motivation

An early pioneer of personalized medicine, Mara Aspinall joins us today. In August she was appointed the new President and CEO of Ventana Medical Systems, and global head of Roche Tissue Diagnostics. Ventana is known for their leading edge instruments and assays which support diagnosis and inform treatment decisions of cancer. Mara is formerly from On-Q-ty where she was founder and CEO. On-Q-ty is a diagnostics start-up focused on using biomarkers in circulating tumor cells to help in the prevention and treatment of cancer. She began her career in diagnostics as president of Genzyme Genetics. Mara has been a strong voice for Personalized Medicine, has sat on the board of the PMC and was a founder of Epimed, the European Personalized Med Coalition. She speaks regularly about the challenges and opportunities in this field. Mara joined us for our first show here at mendelspod, and we are happy to have her back. (Recorded 10/2012)

Diagnostics and the Evolution of the FDA: Mya Thomae, Myraqa

Podcast Sponsor: Ingenuity - iReport, the quickest way to get biological meaning from your expression data. www.ingenuity.com/get iReport/

Guest:

Mya Thomae, Founder and CEO, Myraqa Bio and Contact Info

Listen (9:22) What's least understood about the regulation of diagnostics?

Listen (2:22) How well is the FDA evolving from the old blockbuster drug model?

Listen (6:58) Regulatory advice fo diagnostics developers

Listen (9:32) How do you see the LDT issue playing out?

Listen (5:12) Are diagnostics way undervalued?

Listen (2:24) From music performance to regulatory affairs

Mya Thomae is an expert in the regulation of in vitro diagnostics. On today's show, she shares with us the advice that she gives her clients seeking FDA approval for their diagnostic products. Mya weighs in on the issue of LDTs: the FDA says it has the authority to regulate LDTs, but so far has issued no draft guidance. This is creating an unfair playing field for those producing CoDx, which are regulated. Has the FDA been waiting for the election to issue guidance? Does Obama's reelection or the recent 'Spygate' and meningitis outbreak really affect the FDA? Ms. Thomae travels often to Washington and offers her informed views.

Genomics Around the World with Chris Barbazette, Affymetrix

Podcast Sponsor: Audacity - Building health and science brand supremacy through disruptive marketing and advertising. Download "4 Secrets to Brand Supremacy," for free www.audacityhealth.com/approach

1:08 Population specific genomics

7:03 Personalized medicine and diagnostics abroad

16:15 Agbio

20:02 Are arrays still more widespread than sequencing worldwide?

27:11 What's the most obscure place where you've promoted arrays?

31:00 Personal path to international markets

34:57 Worst airport story ever

Chris Barbazette is Affymetrix's VP for International Markets. He travels the equivalent of the distance around the globe each month. He joins us to talk about what's going on in genomics in such places as Saudi Arabia and China. Are arrays still the most important genomic technology abroad? Where's the most obscure place he's been for work? These are some of the questions we ask in this fun overview.



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