Expert answer:Microbiology Discussion
Solved by verified expert:Please find the attached files. You should write the discussion post regarding the questions as well as reply to two peers (their responses are long and each on the separate screenshot). You should use the articles provided to be able to reply to discussion questions.
screen_shot_2017_10_14_at_11.12.20_pm.png
screen_shot_2017_10_14_at_11.17.08_pm.png
f.d.a._reverses_course_on_23andme_dna_test_in_move_to_ease_restrictions_nytimes_19_feb_2015.pdf
code_breaker_anne_wojcicki_23_and_me_profile_march__2015.pdf
23andme_will_resume_giving_users_health_data_nytimes_21_oct_2015.pdf
Unformatted Attachment Preview
FEB. 19, 2015
New York Times
Business Day
F.D.A. Reverses Course on 23andMe DNA
Test in Move to Ease Restrictions
By ANDREW POLLACK
Anne Wojcicki, chief of 23andme, which won approval of a genetic test for Bloom syndrome.
Credit Peter DaSilva for The New York Times
The genetic testing company 23andMe on Thursday took a step toward being able to offer
consumers health-related information again, winning approval from the Food and Drug
Administration for a test for mutations that cause a rare disease.
The company, a pioneer in offering genetic tests direct to consumers from a sample of spit,
stopped doing health-related testing in late 2013 after the F.D.A., in a scathing warning letter,
said that such tests required the agency’s approval before they could be marketed. 23andMe had
been operating under the principle that consumers had the right to get information from their
own DNA.
On Thursday, the F.D.A. approved a test from 23andMe that would be administered to
prospective parents to see if they carry mutations that could cause a rare disorder called Bloom
syndrome in their children.
The agency also said that, in general, such so-called carrier tests would no longer need to be
approved in advance before being marketed. It also voiced support for allowing consumers in
some situations to have direct access to genetic testing, without a doctor being involved.
“The F.D.A. believes that in many circumstances it is not necessary for consumers to go through
a licensed practitioner to have direct access to their personal genetic information,” Alberto
Gutierrez, director of the regulator’s office in charge of diagnostic tests, said in a statement.
Anne Wojcicki, the chief executive of 23andMe, said the approval was a first step for her
company and the government.
“It shows the F.D.A. is willing and supportive of crafting the direct-to-consumer path,” she said
in an interview. “It’s a very reasonable first step. I would go so far as saying it’s a very generous
first step.”
She said that she believed it was the first time that the F.D.A. had approved a genetic test to be
offered directly to consumers. There are other types of tests, like pregnancy tests, that are sold
directly to consumers.
Ms. Wojcicki declined to say when 23andMe would start offering health information again, but
said it would probably be this year. However, it would most likely be limited to a suite of carrier
tests.
“We want to be back on the market with meaningful information as soon as possible,” she said.
The company was most known for giving customers information about their risk of getting
various diseases. Executives said those tests would take more time to gain approval. But having
achieved approval of one test, they said, the company now better understood what it would need
to do to win clearance of other tests.
The company, based in Silicon Valley and financially backed by Google, says more than
850,000 people have used its service, which costs $99. After it stopped providing health-related
information, it continued to offer ancestry information. It is also offering drug companies and
others access to its data for research, signing deals with Pfizer and Genentech.
Carrier tests are for diseases — cystic fibrosis being the most well known — in which two copies
of an abnormal gene, one from the father and one from the mother, are necessary for someone to
be sick. People with one normal copy and one abnormal copy are carriers and generally healthy.
But if two carriers mate, their children have a chance of inheriting two abnormal copies and
getting the disease.
Bloom syndrome is characterized by short stature, skin redness, distinctive facial features and
increased susceptibility to cancer. Many people with the rare condition are Ashkenazi Jews.
Ms. Wojcicki said she was a carrier for that disease.
To gain approval of its Bloom syndrome test, 23andMe conducted two studies demonstrating
that it could accurately detect carrier status. It did other studies demonstrating that consumers
could follow directions for providing saliva samples and understand the results of the test.
HealtH
Code
Breaker
Anne Wojcicki has clashed with the
FDA in her quest to reveal the secrets of
your DNA. But this tech tabloid fgure
may also be revolutionizing the way we
approach health in the information age.
by Dr. Peter b. bach
well wishers
S
he has endured gossip as
the most famous jilted spouse in Silicon
Valley and been idolized as America’s
most daring CEO, but the proper title for anne
Wojcicki is DNA safecracker. She’s opening
the vault that keeps information about you
fom you, starting with your genetic code. Sure,
the 41-year-old frst landed in the headlines as
Google co-founder Sergey Brin’s other half,
but it’s as the co-founder of the genetic testing
company 23andMe that Wojcicki (pronounced
Woe-JIT-ski) has become a harbinger of the
future of healthcare.
When 23andMe launched in 2006, with
hefy backing fom Google, its mission was
clear: Give individuals direct access to their
genetic makeup and explain what that information may predict about their future health so
they can make proactive choices about their
march 2015
care. Competitors came and went; 23andMe
seemed destined to dominate a feld it had
practically invented. But then the FDA shut
down most of the operation in late 2013, in part
because the agency believes potentially fightening test results should be disclosed only under
doctor supervision, not directly to a consumer.
“I’ve never shied away fom the fact that we
generate information that may be lifechanging,” Wojcicki says. “You might fnd out
that your father is not your father, and you
have a sibling that you don’t know about. And
if I can tell you that you are also at higher risk
for melanoma, that might send you to get your
skin checked.” She is adamant that patients
are smarter than they’re given credit for being,
and she believes that “people can crowd-source
solutions” for themselves. Before 23andMe was
curtailed, the company’s test, called the Personal
T&C
124
Genome Service, was available for only $99. Te
pitch was simple: You send in spit; you get an
e-mail that contains a link to detailed information about your genes: what you inherited fom
your parents, what your ancestry might be,
what diseases you might be at risk for. Now you
can still get ancestry analysis and raw genetic
data, minus the health indicators. (Citizens of
Canada and the U.K. recently gained access to
the original test for about $200.)
Te medical establishment has yet to come
around to 23andMe’s DIY approach to wellness. Wojcicki laughs as she relays a conversation she had with a dermatologist, who said
(bro to bro, apparently), “Dude, stop sending
people to get their skin checked. Do you know
how much I get paid for that? Do you know
how much more money I make when I do
Botox?” It’s exchanges like this that convince
townandcountrymag.com
S p e n c e r low e l l / T r u n k A r c h i v e
Anne Wojcicki envisions
a future in which we
crowd-source the solutions
to our personal health.
HEALTH
Wojcicki that the current healthcare model
genes are arrayed in each of our cells into 46
one gene at a time. But with the scarcity of data
needs to change, even if physicians might
separate strands called chromosomes, which are
available to us today, it’s a little like trying to
remain outside the equation.
organized into 23 pairs—the 23 of the company’s fgure out if someone has a good poker hand
Even though I’m a doctor, I’ll admit there are name—each of which contains a chromosome
when only a couple of her cards are showing.
times when it doesn’t make sense to put us in
fom each of our biological parents. When it’s
It’s a lot of educated guesswork.
the middle, where we are ofen no more than
our turn we pass on one chromosome fom each
Tat was another objection fom the FDA,
rushed messengers. Especially not these days,
pair to our ofspring. Most of these genes are like which considered some of the connections that
when it’s possible for a patient to already be
distant stars in the galaxy: We don’t know much
23andMe provided overconfdent, and potenarmed with quite a lot of information about
about them, but we are slowly fnding out. We
tially wrong. In its letter to the company telling
themselves, thanks to wearable technology that now know, for example, that a mutation (which
it to stop selling its genetic interpretations to
can track activity, sleep, and calorie intake.
Angelina Jolie carries) in the BRCA gene indicates customers, the agency said that “serious conWojcicki, who feely calls herself dude as
an increased risk of both breast and ovarian
cerns are raised if test results are not adequately
well, is speaking to me in a conference room in
cancer. Other mutations can lead to an increased
understood by patients or if incorrect test
23andMe’s one-story ofce building in Mounlikelihood of getting the fatal neurological condi- results are reported.” A spokesman for the
tain View, California, literally in the shadow
tion called Huntington’s disease, or of manageable FDA told me that there are also “no guidelines
of Google’s headquarters. In true Silicon Valley
health issues like high blood pressure.
for healthcare professionals on how to use
style, one quarter of the foor is lef open for
Tere is a long list of genes we think are corthese test results.”
company CrossFit classes, half of the workstarelated to serious diseases, but we don’t underWojcicki agrees that there is still much to
tions are standing desks, and there are few
stand how or why. Many may be caused by
learn. And then she says something that shows
actual ofces, even for the CEO. Wojcicki has
multiple genes working together; some combina- that her DNA is all Silicon Valley: what we
just fnished Facetiming with her six-year-old
tions make you sick, and some don’t.
don’t know today data will answer tomorrow.
son, who is on his way back fom camp. (She
To help interpret the range of genetic diferShe imagines the day we learn about genes and
also has a three-year-old daughter.) During
ences the company was fnding in its customtheir efects the same way Google learns fom
our conversation, texts fom Brin interrupt
ers, 23andMe eventually started relying on
people searching the web. Google’s searches get
us several times. Tough the couple are not
something called genome-wide association stud- smarter by generating data and observing how
divorced, they now live apart—and have since
ies, which search for patterns across a person’s
searchers respond. If Wojcicki could gather the
the Google co-founder became romantically
entire genetic makeup rather than looking at
genetic and health information of, say, a few
entangled with a 27-year-old
million people, she could fnd
employee. Wojcicki says that
the same kinds of connections.
Wojcicki imagines the day we learn about
they’re active co-parents in the
Afer all, the way researchgenes and their efects the same way Google
midst of what appears to be a
ers recently discovered a gene
pretty amicable breakup.
found mostly in Latina women
learns fom people searching the web.
Te seeds for 23andMe were
that protects against breast canplanted when Wojcicki worked
cer was by analyzing data fom
at an investment fund on Wall
about 11,000 women.
Street. She jokingly says she
For now, amid all the red
lef New York to return to the
tape, Wojcicki is trying to
Bay Area, where she grew up,
wedge the door back open with
because she couldn’t face one
the FDA. Tough I’m the one
more meeting in a strip club.
who went to med school, she
But in truth she had been evaluknows far more about genetating and investing in healthics than I do. My training in
care and biotech companies and
the subject (which was fairly
fgured it was time to turn the
standard) consisted of a few
whole thing on its head. “I was
lectures I half slept through in
really fustrated with how conthe early 1990s, a decade before
sumers were treated in healththe frst human genome was
care,” she says. “Tey don’t
fully sequenced. So it’s sort of
really get that much choice.”
a paradox that the FDA trusts
Her goal, she says, has always
my kind, and not hers, to combeen to give it back to them.
municate genetic information.
To do that she and coWojcicki is now trying to
founder Linda Avey decided to
get approval to give test
Sample Size
At the 23andMe lab in
help people unlock their own
results and the accompanying
Mountain View, California,
genetic codes. Each of us has
interpretation for one genetic
a technician prepares to
about 20,000 genes that make
defect in particular. It’s called
conduct a genetic profle.
[ c o n t i n u e d o n pa g e 2 0 0 ]
up our individual DNA. Tose
MARCH 2015
T&C
126
townandcountrymag.com
S p e n c e r Low e L L / T r u n k A r c h i v e
Looking gLass
A Model T
price and quality
had just about no relationship.
We gave ample time to each shirt that
met the criteria. Oscar and I tried it on, critiqued it, and then read the label. We started
with a number of shirts that were, simply,
all wrong: billowing, sleeves too short, no
oomph. Oscar fnally put on one he really
loved—for its proportions, sofness, and ft.
I tried it and felt the same way, and Saphora
concurred. It was fom Gap.
In all cases, and I fnd this surprising given
the diferences in physique, what looked
good on him looked good on me and what
looked silly looked silly (n.b., I am talking
about the shirts, not their wearers). One shirt
that I tried on and instantly ruled out, as did
Saphora, made me look like a dentist at work;
Oscar’s take when he put it on was that there
was “something medical about it.” To my
surprise it was fom Sunspel, a maker whose
shirts I had specifcally requested. Sunspel is
an elite English manufacturer, and I had seen
an ad for its T-shirts, which cost more than
$100 each, and a description of the cotton,
making me think its would be top-of-theline. Later on in the testing we tried another
Sunspel, in a thicker cotton, with a pocket,
and it was superb. So I must say, in defense
of the company, which uses Sea Island cotton
woven in Switzerland for T-shirts made in
Derbyshire, that I assume that the no-go was
an undershirt, while the dashing one was the
only one meant for show.
A company neither of us had heard of,
American Giant, provided the real thing:
the sleeves not too short (a problem with
several), the collar neither too high nor too
low, the material strong but not coarse. Te
one fom Levi Strauss was, for Saphora,
“very gay sailor”; she added that she liked gay
sailors but that she did not think it suited
Oscar or me. APC, the French company, sent
a small, yet they were correct if they thought
that their small was the equivalent of other
companies’ mediums. We all three thought
it had a certain dash, while the one fom
another French maker, Lacoste, was far too
baggy—although in my eyes ideal for tennis
for that very reason.
Te one fom Acne Studios was so nipply
that Oscar looked as if he were auditioning for a porn movie. Te Armani samples
looked more like underwear than something
to wear in public. Te same was true of La
Perla’s. (On the other hand, if a T-shirt’s
[ c o n t i n u e d f r o m pa g e 1 0 4 ]
200 | T ow n A n D C o U n T R Y M AG. C o M
intended function is indeed to be an undershirt, the ft is a diferent matter—unless,
like Brando or Dean, you can aford to be
seen in nothing but your undershirt.)
One shirt I felt instantly allergic to as I
tried it on—it was itchy and clingy—and
then we all burst out laughing when we saw
the way it ft me, which was, as they say, like
a glove. Oscar could hardly get it on. It was,
to my shock, by Jil Sander, a designer I have
interviewed because of her art patronage.
And there is no doubt that it was meant to
be seen on its own. Te only other one that
was equally out of the question was fom Burberry; the material was ribbed like corrugated
cardboard. However, another T-shirt later
in the testing—comfortable, neat in the way
it conformed to the body without being too
tight, the material exceedingly pleasant next to
the skin—was also fom Burberry.
I put on one whose collar was so close
around the neck that I felt like a clergyman;
when Oscar tried it on I expected him to
be holding a chalice. It was fom Brunello
Cucinelli, to me one of the most stylish and
luxurious sources of men’s clothing; I decided
they should stick to suede and cashmere.
Two diferent but similarly “average—okay,
but nothing to say” (Saphora’s take on
both)— ended up being fom Prada.
Ten Oscar tried on a shirt and simply
said, “Tis takes the biscuit.” We agreed, both
when it was on him and on me: marvelous to
wear and somehow very good-looking. “Dior,”
Oscar announced, when he found the very
understated label inside it. We realized that
what made it such a success was that it was
considerably longer than all the others. Te
hem’s being well below the waist—but not
too far—was a pivotal diference.
I then got out, fom my own chest of drawers, the shirt that had started the whole thing:
my Vilebrequin. It was, we all agreed, impeccable, and Saphora felt that the white embossed
turtle logo added a wonderful note. I also
pulled out a shirt I had bought last summer
and still had the tags on it. It was an exceptionally lightweight one made by James Perse,
and I bought it to wear on an upcoming trip
to rural Senegal, where the temperature rises
above 110 degrees Fahrenheit. Tis confrmed
Oscar’s and my opinion that Perse is absolutely
terrifc. Tis small American maker had made,
Oscar told us, the gray T-shirt he was wearing
that day. Perse is to both of our tastes, for the
subtlety of the material, the perfect style, the
sort of elegance that goes with wooden houses
and pine forests and sandy beaches.
Yes, all in a white T-shirt. •
Code Breaker
Bloom syndrome, a
rare condition that causes short stature and a
greatly increased risk of cancer. At the moment
she has 800,000 DNA samples in her database.
To fnd more genetic connections with any certainty, she’ll need several million.
Te value of these samples was proved at
the beginning of this year, when the biotech
giant Genentech agreed to pay up to $60 million to Wojcicki’s company for access to
samples fom patients with Parkinson’s disease
and their frst-degree relatives.
While 23andMe was reined in by one
government agency, another, the famously
choosy National Institutes of Health, just
gave it a $1.4 million grant to turbocharge the
company’s web-based capture of data fom
patients, so that some day it can marry what
the company fnds in your DNA with what
you tell it about your health.
Even though she’s now colossally
wealthy—something that seems hard to
reconcile with the woman in the moisturewicking workout shirt laughing and juggling
a dinged-up iPhone with a dead battery—
Wojcicki ofen refers to work she did in her
twenties, when she was a volunteer patient
advocate at Bellevue Hospital in New York
and later at San Francisco General. She asks
me to speak for my profession and explain
why patients still can’t see their own results
fom clinical research studies they join. Te
best answer I can provide is that it has always
been this way. “People should be able to decide
where their data goes,” she says. “If you want
to share it for breast cancer research, then you
should be able to decide to do that.” Tis is
just one of the many popular conventions in
healthcare she is determined to challenge.
Wojcicki may be controversial, but she has
earned the respect of even her competitors.
Randy Scott is a co-founder of Invitae, a
genetic testing company that works directly
with doctors and genetic counselors, not customers. About Wojcicki he is clear: “She’s a
sincere advocate for patients and is bringing
the whole feld along by …
Purchase answer to see full
attachment
How it works
- Paste your instructions in the instructions box. You can also attach an instructions file
- Select the writer category, deadline, education level and review the instructions
- Make a payment for the order to be assignment to a writer
- Download the paper after the writer uploads it
Will the writer plagiarize my essay?
You will get a plagiarism-free paper and you can get an originality report upon request.
Is this service safe?
All the personal information is confidential and we have 100% safe payment methods. We also guarantee good grades