digital PCR

Need Better Standards for Your Clinical Assays? NIST Can Help

The life science tools space is flourishing. Biomedical research output is at an all time high. Today’s guest says there are over 40,000 papers published each year on cancer biomarkers.

But very few of those become commercialized tests. Why?

Many had hoped the FDA would step in and save the diagnostics industry from itself, from a race to the bottom when it came to being able to reproduce clinically relevant tests. But that’s obviously on hold. In the meantime, others are stepping in. And there is one government agency which has no regulatory authority but some power to help out.

Kenneth Cole is the group leader for developing bioassay methods and standards at the National Institute of Standards and Technology. His group has just created a new set of standards and methods for HER2 testing which is available to the clinical lab community to help improve their own assays. It’s been said on the program that this very common test for use in cancer therapy has a false positive rate of 20 percent. That's too many patients getting told the wrong thing.

Ken’s group is now going to work on EGFR and other common tests, and they can help the testing community in several ways. First of all, Ken says, they have a “the luxury of being able to focus in on the measurement techniques and on examining all the sources of variability in an assay." They also work on characterizing cell lines, which have become “an essential part of modern biology.” Ken says a big part of the work at NIST is the education of the community and of the new crop of scientists.

Do you have an assay you’d like help with? Ken is easy to reach, and NIST welcomes your requests. They have set up many partnerships from loose collaborations to projects with IP protection.

Often the best place to find solutions is in going back to the basics.

Want to Stop Smoking? Start with Epigenetic Biomarker that Tells Doc the Truth

Why are there no viable psychiatric genetic tests, we ask today’s guest.

Rob Philibert is a geneticist and psychiatrist working at the University of Iowa. He admits at the outset of today’s interview that the field of psychiatric genetics is in a “quandary.”

“The results are not matching the hype,” he says.

The place Rob has found some success is in studying epigenetics. His lab perhaps leads the world in understanding the effects of tobacco, alcohol and cannabis use on DNA methylation. An epigenetic biomarker test can tell doctors, for example, whether a person smokes and how much. Rob has founded a company, Behavior Diagnostics, to commercialize the test.

So how does this help a person quit smoking?

Rob says that there can’t be therapy until there is accurate testing.

“We like to fudge when we talk about smoking. When you look at studies, half of individuals who are smokers will misrepresent their smoking to their physicians, even when directly asked.”

Think of glucose testing for diabetes, argues Rob--reliable data about the patient is at the heart of any effective treatment.

The test wouldn’t be possible without digital PCR, Rob says, giving a shout out to technology made by Bio-Rad and funding provided from the NIH.

Digital PCR Opens Up New Liquid Biopsy Opportunity in Melanoma Treatment: David Polsky, NYU

The history of science is also a history of toolmaking. And nowhere is this more true than in modern biology. New instruments in the lab allow biologists additional modes of discovery, new levels of quantification, and the opportunity to pursue new and old questions with more data.

David Polsky is a dermatologist and researcher at NYU’s Langone Medical Center. Last week he received a grant from the NCI for readying a new liquid biopsy test that tracks the progression of melanoma for the clinic. Until now, there has been no blood based marker that was able to track melanoma as there is with other cancers such as prostate cancer and the PSA (prostate specific antigen) score. This new test, which could be a major breakthrough for the treatment of melanoma, targets seven mutations which occur in 70% of melanoma patients. These mutations are found in cell free, circulating tumor DNA.

In today’s interview, David points out that the test is possible only with the advent of digital PCR and its ability to measure DNA more with absolute quantification and sensitivity. We knew these mutations before, but just couldn't measure them.

“Droplet digital PCR has been a major breakthrough in our ability to detect rare events and also to quantitate them with accuracy and precision. Those two features are absolutely critical,” says David.

David and his group have been collaborating on the test with Bio-Rad, who makes the ddPCR instruments and designed these tests, and with Molecular MD. Clinical trials with Bristol-Meyers Squibb are expected. Now, with the preliminary science published, the NCI grant will go towards developing analytical and clinical validation so that the test might be commercially available for patients soon.

Digital PCR 'Hits Its Stride'

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George Karlin-Neumann, PhD, Director of Scientific Affairs" for Bio-Rad's Digital Biology Center Bio and Contact Info

Listen (5:00) Understanding Digital PCR

Listen (4:41) Advantages

Listen (1:40) Applications

Listen (3:40) Still room for Real Time PCR

Listen (3:14) First ever dPCR conference

Hanlee Ji, MD, Medical Oncologist, Hematologist / Oncologist in Stanford Bio and Contact Info

Listen (5:09) How is an oncologist using dPCR?

Listen (4:56) A physicians take on personalized medicine

Listen (5:32) Digital technologies already adopted in clinic and dramatically changing war on cancer

In May of this year Nature Methods published an article, “Digital PCR hits its stride.” What is this new technology? Will it replace more conventional methods such as Real Time PCR? And what new opportunities does this new disruptive technology open up?

To answer these questions, we’re joined by George Karlin-Neumann, Director of Scientific Affairs at Bio-Rad’s Digital Center and Hanlee Ji, a physician scientist at Stanford. George explains the exciting new technology and its advantages over Real Time PCR. Hanlee talks about the adoption of the technology in the clinic for the treatment of cancer.

Blu-rays to Chips: Sony DADC Enters Life Science and Diagnostics Industry as OEM Partner

It came as a surprise that I was referred to a fellow from Sony some time back. Huh? Makers of my original Walkman? Dr. Ali Tinazli is the Director of Business Development and Sales for a new division called Sony DADC -Biosciences. There’s Sony Corp based in Japan, then there’s Sony DADC International which has been headquartered in Salzburg, Austria for a quarter century. With a yearly revenue of $2.2 billion, 35 plants worldwide, and a workforce of over 7,000, Sony DADC is the world’s leading supplier of Blu-ray discs.

Sony DADC Producing 'Smart Consumables' for Life Science

(Read our blog about Sony DADC.)

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Ali Tinazli, PhD, Director, Business Development and Sales, Sony DADC Bio and Contact Info

Sony goes B2B in life science Listen (6:07) Sony goes B2B in life science

Scalability, from glass to plastic Listen (3:12) Scalability, from glass to plastic

OEM only Listen (13:31) OEM only

Collector of rare books Listen (1:52) Collector of rare books

I’m happy to welcome Ali Tinazli to mendelspod. He’s the Director of Business Development & Sales for North America for the new life sciences division of Sony DADC. That’s right, the world’s fifth largest media conglomerate and maker of electronics products from play stations to Blu-Rays now joins the life science industry with a division called Sony DADC BioSciences. They have recently announced a deal with RainDance Technologies, a leading provider of microdroptlet-based single molecule and single cell analysis solutions.

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