CDCV, Deck Chairs of the Titanic? We shall see.......

It looks as if the VC team has completely taken over Navigenics. Dana Mead of KPCB and Sue Siegel of MDV will be taking over. Mari will stay on as a Board Member.

This whole thing has me wondering........if I pitch an idea to VC, will they turn me down, only to "create" the exact same company? "Oh, we don't sign NDAs"

A lot of Entrepreneurs out there are asking the same questions.....I think they are right to ask these......Despite what they say.....

It seems Navigenics is one of those VC started companies.........and it looks as if they can't pull out.

Why? Well, this seems to be their baby.....Much like Google's baby is 23andME.

Any other sane investor would have pulled out of these companies when the regulations hit. But, now it seems as if these companies are firing their webmasters, outsourcing the work and looking to save face.

What really would hit them hard is if a new round of regulations were to get in their way.....

Many of my detractors say "If these companies die, so does personalized medicine"

I often laugh when I hear this. Is personal genomics the same as personalized medicine?

The short answer is no. The long answer is No Freakin Way!

Most of these markers don't help us at all. The only thing useful here is the social milieu which they are trying to create.

23andME seems to be doing the best job of that. However, with chat rooms filled with medical misinformation, I wonder how useful these sites will become....

The Sherpa Says: Navigenics hasn't fully turned clinical yet........They will once this move is completed and we will have another 2 clinical diagnostic companies that have an undetermined clinical utility. It takes 5 years to prove utility and I think KPCB and MDV are in for the long haul.......Maybe it is the beginning of the end and these guys are just re-arranging deck chairs. Time will tell, Vamos a Ver....

The beginning of the End? Mari leaving Navi?

Mari Baker is leaving Navigenics......

I am fairly certain of that....

Unless you can be the CEO of 2 companies at once.......

"PlayFirst Expands Management Team to Address Growing Consumer Entertainment Market; Recruits Senior Industry Veterans in CEO, CFO Positions


SAN FRANCISCO, Feb. 26 /PRNewswire/ -- PlayFirst, Inc., the award-winning entertainment company, today announced that Mari Baker, a consumer software and internet industry veteran, has been named its Chief Executive Officer. The company also announced today that Jim Wandrey has joined as Chief Financial Officer. PlayFirst, one of the leaders in casual entertainment, recruited the new leadership to address the growing market opportunity in interactive consumer entertainment."


Or maybe they're restructuring. Or maybe a major VC is pulling out???

All the best Mari. I hope your next company doesn't have a multi-million dollar open bar party for 9 days in SoHo.

-Steve

HT: BC at EG

The Sherpa is Right! DNADirect moves into the clinical space.

As if my conjectures weren't enough, it seems to me that the DTC genomics space is proving my theories to be correct. It turns out that the real value is in providing analysis of the genetic material, NOT testing itself. When you start giving interpretation, you begin to incur regulations that were not applied to those labs who are doing the tests.

It turns out, people don't like buying genetic tests online. In fact, one of the oldest DTC genetic testing company is NOW turning into a genetic counseling resource service.

According to the DNADirect site:

DNA Direct can help your physician practice or medical center meet this challenge by providing access to genetic expertise that can be seamlessly integrated into patient care.

It turns out that this was one of the things we did at Helix Health of Connecticut of CT about a year ago. We sat a CGC down in a busy IM practice and hoped that they would share and learn from each other. We also hoped it would lead to more referrals.

It didn't lead to too many more referrals, but it did bring the doctors up to some sort of speed. I think this is DNADirect's attempt to get physicians comfortable with genetics and I commend them for this. But I also know that they are in discussions with insurance providers to offer genetic counseling services for Insurers......much in the same light as my friend Heather Shappell.

Here's what I think. The DTC Companies will all evolve in some aspect towards providing professional services. Navigenics does, deCode is moving in this direction and NOW DNADirect is moving into this space. So much so that they are seeking out insurers to provide these services......In fact based on what I am reading they are looking to serve as a "dial a genetic counselor" for regular physicians in everyday practice.

I have thought about providing this service too, but you see physicians actually have a limitation that genetic counselors don't. Physicians have to be licensed in each and every state that they provide medical care......EVEN Telegentics care.....

Counselors don't. I think this is a good thing for counselors, but a bad thing for Pharmacogenomics and Common Adult Disease Genetics. Maybe, this is the out for 23andME????

Or maybe they (23andMe) will continue to deny that they are providing genetics services..........

You see, Heather had pioneered TeleGenetic Services for Cancer genetics at her company "Informed Medical Decisions"

She landed a contract with Aetna and is looking at more third party providers.....

This is a key to expanding our services. Most providers are unaware of OR improperly use genetic testing to aid health services. If you can land in every physicians office with a warm voice and some key skills, it would be very useful........rather than some discussion boards where voodoo medicine and medical misinformation is passed between patient and patient.

That being said, BRCA testing seems to be easily integrated in Internal Medicine services according to recent analysis.....so maybe doctors are starting to get at least one part of it......

What amazes me about 23andME is that a lot of their discussion boards are not proctored by healthcare providers to correct misinformation. This inevitably results in a 17 year old being scared of his prostate cancer risks and someone interjecting "Oh don't worry, more sex can help you prevent prostate cancer."

Is that really outsourcing medicine? Is that really democratizing knowledge? In my mind it is spreading misinformation under the guise of scientific authority.......

I do predict that the other DTC companies, good bad or ugly, will begin to follow Informed Medical Decisions and NOW DNADirect........which are becoming virtual extensions of things like our practice at Helix Health of Connecticut.

The Sherpa Says: Hey Dietrich, if you read this.....do you remember the "Apple Stores???" Ryan has been the leader here and it is clear......the services around the genome are the most valuable things............

23andME-"Genetic Counseling isn't Clinical Medicine"

Thanks to an amazing string of commentary on my blog, I think I get it.

Most of the 23andME users don't understand clinically what they are getting. It turns out, what they are getting is in essence unsupervised genetic counseling.

Vincent a commenter notes from my previous set of comments:

"In their actual report to customers, though, their language is much more sane.

E.g.Carrier for the 6174delT BRCA2 mutation.

Lifetime risk of breast cancer for women is increased from 13% to 85% and risk of ovarian cancer is increased from less than 2% to 23%.

May significantly increase risk of prostate cancer in men. There is also an increased risk for breast cancer in men.

That an accurate (as best as I can tell) statement of fact, and one that does not cross the line into the area of clinical diagnosis."

I then clue him into something he may not get and in fact I didn't get it until we talked about it.

SHERPA-"What you said is in their report is EXACTLY what a genetic counselor would tell their patient......."

Which prompts a reasonable conclusion by Vincent, which is absolutely incorrect. Why? Because we assume genetic counselors are autonomous units.

VINCENT-"A doctor or genetic counselor would take the conversation much further, however, and that is the key point I think. A licensed practitioner has the ability and obligation to go far beyond the purely statistical and into the truly clinical. Family history, behavioral factors, prevention options, treatment options, and so forth.

A company like 23andMe does not have that obligation, and it seems like that is part of what drives you bonkers."

He nailed it without realizing he did. When 23andME presents you this information in such a fashion, they are providing exactly how a genetic counselor would. They are probably painstakingly creating reports that are word for word what genetic counselors would deliver.

In addition, he double nails it. 23andME is providing genetic counseling while abdicating any of the clinical responsibility of putting that information out there. This is especially troublesome with highly penetrant tests, such as BRCA.

He triple nailed it by describing the argument 23andME will likely use

Our reports look like Genetic Counseling, But that's NOT Clinical Medicine/Genetics

I saw this attitude when I sat at a roundtable with Ryan Phelan of DNA Direct, Jeff Gulcher of deCode, Dietrich Stephan of Navigenics and Joanna Mountain of 23andME in San Francisco last June.

When asked "What if this genetic information changes? Who is responsible to notify customers/patients of this change?" What erupted was a slew of finger pointing at the table and Ryan Phelan saying "It would be nearly impossible to ask us to recontact customers with that change in information (rough quote)" Dietrich said "We have a subscription service that you pay for to get those updates" Mountain and Gulcher were silent.

But I grabbed the mic and said "If a physician orders a test and the results change, that physician is legally and morally obligated to report that change to you, at no cost and for the rest of the time that patient is under your care"

That is responsibilty. When I say there is a fundamental lack of willingness to accept this accountability at the highest levels, I mean it. I have seen what they have had to say, and they are left lacking.

Some may say, well 23andME is not practicing medicine. But I tell you, what they are delivering smells, looks and feels an awful lot like what any genetic counselor in any town in the United States, UNDER PHYSICIAN SUPERVISION, would be providing to PATIENTS who underwent BRCA testing.

So genetic counselors, if I haven't alienated you and you are still reading the Sherpa......Beware, 23andME is looking to replace you with reports. In addition, they are arguing that what you do isn't technically the practice of healthcare/medicine......

If you let them get away with this argument

1) Their will be a legal precedent which may ruin any argument your group has to be licensed

2) They will erode the patient trust bond with your patients

3) They will unltimately replace you and a physician will be using this service instead of consulting you.

This ball is now in NSGC's court. I hope you can do something about this, before it's too late.

The Sherpa Says: 23andMe's response "Yes our reports look like genetic counseling, but that's not clinical medicine......." Ouch.......

10 months........

Forbes April 2008


"Both 23andMe and DeCode, which has not received a warning letter from New York so far, argue that the lab testing laws don't apply because their products are not medical tests. "23andMe's services are not medical ... they are educational," argues 23andMe spokesman Paul Kranhold. "

"One worry is that people who order online gene tests could get misleading information. For example, 23andMe tests for some gene variants involved in mildly raising breast cancer risk, but not genes called BRCA1 and BRCA2 that vastly raise breast cancer risk. Harvard Medical School's Mark Daley says if you found out that you had genes that slightly reduced the risk of cancer, but didn't check for the real cancer-causing gene like BRCA1, "you get a potentially dangerously misleading answer."


What a difference 10 months makes........


I am certian testing for limited amounts of mutations is probably just as confusing.....

From 23andMe

BRCA Cancer Mutations (Selected)

Breast/Ovarian Cancer is one of the diseases that 23andMe analyzes. Our service includes the following information:

• Whether or not you are a carrier for Breast/Ovarian Cancer.
• Information on SNPs i4000377, i4000378, i4000379, markers that influence your carrier status for Breast/Ovarian Cancer.
• A look at how Breast/Ovarian Cancer works, and a list of counselors, links and support groups for BRCA Cancer Mutations (Selected) in your area.
  

Carrier for Breast?Ovarian Cancer???? What kind of language is that? One thing is for sure "Carrier for Breast/Ovarian Cancer" sounds an awful lot like genetic risk for breast cancer carrier.......otherwise known as a medical diagnosis code V84.01

It depends on what the meaning of the word "IS" is

Shameful doubletalk........

The Sherpa Says: Russ, in what world is this something worthy of your support?

I am not a man.......

As I post in the "southern command" I want to announce.....

I AM Not a Man.

I repeat.

I Am Not a Man.

I know, I have man parts.

I may have a hairy chest like a man.

I may have an X and a Y.

But I repeat, "I Am Not a Man!"

I am dead serious. I AM NOT A MAN.

In a statement to Pharmacogenomics Reporter, 23andMe stressed that offering BRCA testing does not mean the firm is moving into the medical genetic-testing space.

It sounds just as silly, doesn't it?

BRCA testing is NOT A MEDICAL GENETIC TEST.......

BRCA testing is NOT A MEDICAL GENETIC TEST......

I think Myriad will beg to differ. A whole bunch of Geneticists and Counselors would as well......Just ask Ellen Matloff CGC, Research Scientist at Yale......

"Only a doctor can provide a medical diagnosis and we report information that the current state of genetic research and our technology allows. "

Last time I checked, Genetic Counselors, Nurse Practitioners, Physicians Assistants AND Doctors report medical genetic test results,...........SO DOES 23andME! But unlike 23andME the others do so in the supervision of a licensed physician. But it doesn't change the fact that presentation of genetic testing results is making a diagnosis.

Hey Linda, have you ever heard of a V84.01 or V84.02? No? Why should we expect you to? You aren't a doctor, but your company IS PERFORMING MEDICINE everytime they tell a patient they have a BRCA mutation. In essence you are reporting that the patient is a V84.01 or V84.02.

23andME is NOT PRATICING MEDICINE

23andME is NOT PRACTICING MEDICINE

Well..........

It depends on what the meaning of the word "IS", is.

What this shows is a true lack of accountability in a lame attempt to:

"Democratize the Unlicensed practice of Medicine"

I view this act in the same light I view AIG's CEO saying everything was ok, 2 days before AIG's collapse

Or when A-Rod was asked "Have you ever used steroids, human growth hormone or performace enhancing drugs"..........."NO"

Where is the accountability today?

The Sherpa Says: Linda, Anne, Sergey, Eric....admit your mistakes, accept your regulations and become a medical testing company. Because if you don't, if you try to play a "Definition of Is" on the public, then the chain of trust between patient and testing laboratory as well as between physician and testing laboratory will likely be broken. That is a risk, healthcare cannot afford........Because of your arrogance, we may need to once again ask the law to repair our chain of trust. To practice medicine, you need that chain of trust. It is essential to medicine! And you make a mockery of it.

Why Facebook and Not 23andME?

Ok, so I am certain you are all aware of the big hulabaloo surrounding good 'ol Mark Zuckerberg and Facebooks' plans to sell user provided content to companies.........The FacebookOSphere was up in arms!!!!!

What happened? He backed down.

Here's my question? Why in the hell do you care about that Drunk Photo more than you care about the information contained in your genome. That Drunk Photo is only a snapshot of your poor decisions at 21, easily explained away. But your genome? How do you explain away an APOE e4 genotype? What about a Huntington's Genotype? Familial Hypercholesterolemia?

I hope you see where I am going. Once your information is online and once you sign a terms of service which says I'm ok, you can end up with this.

To be clear, it's your choice. "We never sell data" without customer consent, Avey says. For personal data, customers consent every time they volunteer for a drug manufacturer's research project. But 23andMe will not notify customers every time they sell genetic data; in that case, a customer's initial consent -- given when first signing up for a 23andMe test -- suffices.

Mark Zuckerberg learned the hard way when he had millions of customers. Maybe since, 23andME doesn't have that kind of user lobby yet, they won't feel the pressure. But since they are already selling customers' genetic data to any one they please, the pressure won't be felt until they have already made millions......

Oh and BTW, User provided content is granted a worldwide, non revocable license to 23andME too........(That certainly smells awfully close to ownership to me).......

With the exception of your saliva sample, 23andMe does not claim ownership of the materials you provide to 23andMe (including feedback and suggestions) or post, upload, input, or submit to the Service (collectively "Submissions"), unless otherwise specified. However, by posting, uploading, inputting, providing or submitting your submission, you are granting 23andMe, its affiliated companies, sublicensees (including but not limited to sublicensees who avail themselves of the Limited License granted in Section 6 above) and successors and assigns a nonexclusive, worldwide, royalty free, perpetual, non-revocable license to use your Submissions in connection with the operation of their Internet business, including, without limitation, the rights to: copy, distribute, transmit, publicly display, publicly perform, reproduce, edit, translate, reformat, and create derivative works from your Submissions.

Imagine if Zuckerberg had asked his Facebook fanatics to agree to this one!!!! He'd be outta business in a heartbeat.....

It's funny how the rules only apply to certain companies......

I am amazed that all of these technophiles like to verbally assault me about how I feel about 23andME, yet most of the field feels THE SAME WAY about Facebook and some stupid drunk photos or illicit pics......And both companies are saying "just TRUST us" but with Terms of Service like that, how can you???

I guess it's a case of the "A-Rods"..............more people in NYC cared about that than the Stimulus bill signing.....Sad.....

The Sherpa Says: When will people realize that selling your information shouldn't be taken so lightly. It looks like Drunk Pics mean more than SNPs......that's because of public health illiteracy. We should focus on health and physiology not sex-ology in health class.