Huvi biotehnoloogia vastu
Kommentaari jätmiseks loo konto või logi sisse
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Jälgides iga päev NASDAQ-i website'ilt Most Active lehekülge, hakkab silma biotehnoloogia aktsiate osakaal. Biotehnoloogia aktsiad on harilikult suuremad tõusjad ja muidugi ka langejad. Tundub, et kui vähegi saaks aru selle sektori põhimõtetest, oskaks kompaniisid analüüsida, siis võib õieti ajastatud investeering tuua hea reward'i.
Pidevalt tehakse uusi avastusi ja chemistry abil parandatakse oluliselt inimeste karakteristikuid. Peagi võib ära unustada jõusaalid, sest vastavate tablettide abil saab ühe päevaga vastavaid lihaseid suurendada; ilukirurgid, kes implant'e paigaldavad, kaotavad oma töö, sest tablettidega saab igaüks vormida iga poole aasta tagant sobiva rinnakuju; pissida võib ka üle päeva, kui geneetiliselt suurendatud põis seda lubab, jne, jne.
Siit küsimus-- kustkohast biotech'i kohta tõsisemat informatsiooni saaks?
Vastukajad?
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Anna meiliaadress.
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miks mitte foorum?
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Paljud tasulised allikad pakuvad head infi selle kohta. Näiteks First Call :)
Aga tasuta saab alati kvartaliaruandeid SECi koduleheküljelt, www.metamarkets.com all on sageli biotechkommentaare, tõsi tüübid kaotavad ise raha sellega enamasti...sama lugu ka tasulise realmoney.com biotech-tibi Lissa Morgenthaleriga, kelle biotech-fond on üks sitemaid omasuguste hulgas...jne...
Unistus, et jess - uuriks biotechi ja teeks pappi sellega, on teostamatu, trust me, see on news-driven industry, kus võid ühe ööga kaotada 70% oma rahast, seda hetkel, kus oled teinud all available homework... GNLB, TTP on viimased head näited. -
Loowi: soren.vetevool@lhv.ee
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Loowi, thanks. Research oli huvitav.
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Loowi, su enda tehtud research v6i?
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Tahad kirjas6braks saada v2?
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Idee poolest 100% nõus - biotehnoloogial on tulevikku küll-ja-küll.
Kuid võimesse potentsiaaliga biotehnoloogia-aktsiad välja sõeluda suhtun eriti suure skepsisega. Selleks peaks omama suurepäraseid teadmisi nii süva-biotehnoloogiast kui finantsmaailmast. Ja kahtlen kas meist keegi omab neid.
Üks võimalus on muidugi screenida ilusasti kasumit toovaid biotehnlooge, kuid biotehnoloogiat ostetakse ju põhiliselt tuleviku pärast ja seega pole antud hetkel kasumlike stokkide ostmisel suurt point'i.
My take - kui midagi üldse osta, siis biotehnoloogia (BTK) indeksit, üksikute stokkide ostmine on täiega kasiino. -
vaata www.biospace.com, see on just biole orinteeritud investoritele!
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Vahest erineb muust kasiinost(loe:investeerimisest) vaid tõepoolest pikema tsükli tõttu uurimisest/arendusest müügini?
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Ostsin USAst mingi raamatu "Biotech Investor's Bible", mis hoolimata oma pretensioonikast pealkirjast annab p2ris asjaliku ylevaate, mida silmas peab pidama. See ei t2henda, et k6iki neid p6him6tteid j2rgides tingimata kasum tuleks, a noh...
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Some fun QQQ facts ---
o) AMGN is the 6th largest stock on the NASDAQ market. Bigger than DELL, SUNW, AMAT, WCOM, and JDSU among other notable tech stocks.
o) ABGX has a bigger weighting than AMZN.
o) In the last month, 18 stocks in the NASDAQ 100 are up - 6 of them are biotechs -
Inffi saab ka päris lähedalt ja päris varsti: www.geneforum.ee
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Kui kellegil testimiseks katsejäneseid vaja, siis www.geenipank.ee abiks.
Suht koledad jänesed ainult. -
LOL
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Burrill's predictions:
-- We will see more collaboration and M&A activity as the industry
continues to bridge technological gaps and achieve more integration
in an effort to move towards a more automated and efficient approach
to drug discovery and development. We'll also see more success
stories in the personalized medicine arena as companies grasp the
benefits of parallel drug discovery (where the diagnostic and
therapeutic are developed synergistically) and are able to design
more effective clinical trails by stratifying patient populations
according to their genetic predisposition.
-- The debate over stem cell and cloning technologies will continue and
we may very well experience a setback in this important area if
emotion and misunderstanding win over sound scientific reasoning.
-- Although PDUFA III has been hammered out to the industry and the
government's liking, there is still no commissioner at the FDA -- a
situation that is, according to nearly every pharmaceutical and
biotech company, topping their list of problems with the agency.
-- With bioterrorism legislation and funding in place, we will see more
and more contracts doled out to biotech companies working on new
vaccines and therapeutics to treat infectious diseases and we'll see
improved diagnostics, especially those that are quick, effective,
and inexpensive. We'll also see improvements in the medical and
public health infrastructure in many states in the US ... in fact,
these efforts are already underway.
-- Diagnostics will continue to gain in importance. Indeed, the
Burrill Diagnostics Index has consistently outperformed the NASDAQ
and DJIA since the start of the year and had gained 1.2% by the end
of May. The recent announcement (June 5) from LabCorp to offer
Myriad Genetics' predictive medicine products to 200,000 LabCorp US
physician clients underscores the growing importance of the
molecular diagnostics industry ... increasing evidence of our march
toward personalized medicine.
-- Some areas of biotech, most notably the platform toolbox companies,
will keep on struggling and morphing their business models into ones
that have more appeal on Wall Street ... but chasing Wall Street's
value model is always dangerous.
-- Agbio will continue its upward trend as GMO's gain further
acceptance among farmers and consumers. We will see more recovery
and investment in this area as agbio companies continue to explore
the use of transgenic plants for therapeutic protein production and
turning crops into biofuels.
-- We're going to see interest in biotech grow on the international
front. The new biotechnology strategy coming from the European
Commission will stimulate the industry, and we'll see an increase in
US/International collaborations and acquisitions.
-- Asia will also emerge as a more powerful global players, using
Asia's strengths -- strong capital markets, large unmet medical
needs, rapidly growing populations-both to deploy the world's
technology at home and to invest in the global arena. In addition,
the introduction of traditional Chinese medicine (TCM) to the world
stage (and particularly to the United States) has fostered new
science and new tools to elucidate active ingredients. Asia is
eager for the technology and business opportunities in the Western
world offers and vice-versa. Now that China has jointed the WTO,
one of the biggest stumbling blocks for Western business investment
-- the potential threat to IP protection -- will have (hopefully)
been removed.
-- And, as for the capital markets, we are likely, despite our slow
start, to see a dozen or more IPOs before year end. We'll see PIPEs
continuing to be a popular form of financing and we'll also see a
flurry of secondaries. Although convertible debt has been a popular
vehicle so far, we may see less of this activity as the capital
markets gain strength and biotech's popularity resurges. We'll see
a $15-$20 billion financing year and we'll see biotech once again
outperforming the NASDAQ and the DJIA by the fourth quarter ... that
is, barring another terrorist attack or an intensification of our
military presence in the volatile Middle East.
ja mis siis viimastel kuudel on juhtund:
March - Bad News
ISTA ISTA $2.83 $0.91 -68% Vitrase, injectable
treatment for vitreous
hemorrhage, fails to
meet primary endpoints
in Phase III studies
GLFD Guilford $9.63 $8.14 -15% Gliadel wafer received
a non-approvable letter
for a supplemental
application for use in
malignant glioma
VPHM Viropharma $13.41 $5.50 -59% Picovir, which reduces
the duration of a cold
only one day, is voted
against in FDA Panel
of experts
CRXA Corixa $9.63 $6.15 -36% Bexxar, for
Hodgkin's-Type
Lymphoma, is notified
by FDA that current data
is insufficient for
approval
March - Good News
ELN Elan Corp. $14.00 $14.20 1% Avinza, for chronic
moderate to severe pain,
received FDA regulatory
approval
LGND Ligand $16.52 $18.05 9% Avinza, for chronic
moderate to severe pain,
received FDA regulatory
approval
SRA Serono SA $19.59 $22.21 13% Rebif, interferon for
treatment of multiple
sclerosis, gains FDA
Approval
April - Bad News
CVAS Corvas $5.98 $3.15 -47% UK-279,276, drug for
ischemic stroke, failed
to meet primary endpoints
in Phase IIb and was
abandoned
MOGN MGI Pharma $14.75 $8.59 -42% Irofulven, for
gemcitabine-refractory
pancreatic cancer,
Phase III Trial stopped
and drug abandoned
XOMA Xoma Ltd. $7.63 $4.42 -42% Xanelim, a psoriasis drug,
produced poor
pharmacokinetic data in
preparation for market
DNA Genentech $48.99 $44.70 -9% Xanelim, a psoriasis drug,
produced poor
pharmacokinetic data in
preparation for market
April - Good News
TRMS Trimeris $39.25 $50.50 29% T-20, HIV Fusion Inhibitor,
has better than expected
results in a Phase III
trial
ISTA ISTA $0.83 $1.27 53% Vitrase, injectable for
treatment of vitreous
hemorrhage, gets go-ahead
to submit NDA after new
endpoint is recognized
May - Bad News
IBPI Intrabiotics $3.90 $1.19 -69% Iseganan, designed to
prevent oral mucositis in
radiotherapy patients,
identical to placebo in
Phase III Trial
EMIS Emisphere $10.96 $5.16 -53% Oral Heparin,
anticoagulant/antithrombotic
agent, fails against
incumbent drug in
Phase III
VPHM ViroPharma $4.25 $3.33 -22% Picovir, which reduces
the duration of a cold
only one day, anticipates
a "Not Approvable" letter
from FDA
PDLI Protein Design Labs $12.27 $12.28 0% Zamyl, acute myeloid
leukemia treatment,
failed to show
statistical significance
against placebo in
Phase III
EMIS Emisphere $10.96 $5.16 -53% Oral Heparin,
anticoagulant/antithrombotic
agent, fails against
incumbent drug in
Phase III
May - Good News
BGEN Biogen $40.36 $49.47 23% Amevive, novel psoriasis
drug, is recommended for
approval by FDA Panel of
experts
UTHR United $13.65 $14.71 8% Remodulin, for treatment
of pulmonary arterial
hypertension, approved by
FDA after design of
Phase IV
Average effect of good news 19%
Average effect of bad news -40%
Ratio Bad News to Good News 13 to 7 Nearly 2:1 prevalence of bad to good news -
know howd on biotechis investeerimiseks küll tarvis, eriti kui olete long. ise hoian eemale enamustest suurtest tegijatest nagu amgen, genentech, biogen etc. viimased paar nädalat olen suunanud hulga raha mlnm, hgsi ja imgn suunas. nad kõik on odavad praegu, umbes 1.5Xbook value. Eriti julmalt on alla löödud mlnm, kuigi neil on väga hea pipeline. eelmise nädala uudis fast track approvalist ei suutnud isegi ära hoida fondide sell offi. arvan et kolme aasta pärast on nad plussis ja selleks ajaks on neil peale integrillini veel kaks ravimit toodangus. immunogenil on hea tehnoloogia kuigi parajalt riskantne. tema osakaal portfellis ei tohiks olla suurem kui paar protsenti.
olen mõelnud shortida celerat aga olen vist hiljaks jäänud. see on ikka üks tobe farma-to-be. pole neil ju midagi ette näidata ja nende ip on ka päris nõrk ja pipeline on täitsa tühi. Sama kehtib ka incyte kohta. -
Biotehnoloogia on tõesti huvitav ja targale investorile ilmselt ka tulutoov.
KUID, tark investor biotehnoloogia vallas olema lõpetanud ilmselt nii majandus- (et hammustada läbi ettevõtete bilanssidest) kui ka arstiteaduskonna (et eristada "terasid sõkaldest - millised biotechid kujunevad edukaks).
Minule käib viimane punkt üle jõu ja seega ei julge üksikutesse biotehnoloogia aktsiatesse pikaajaliselt investeerida. Aga 10-20% portfellist biotehnoloogia indeksisse (kas BTK või IBB) panna oleks minu meelest riskialtile investorile küll hea mõte. -
ka ML holdersid BBH ja PPH pole pahad
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Pikaajaliselt on mõttekas indeksitesse investeerida, kuna tegu on ühe riskantseima sektoriga üldse. Selleks, et üksikuid firmasid valida, oleks mõttekas vaadata pipeline's ainult 3. - NDA faasis olevaid ravimeid. Praegu enam õhku ei osteta.
Samas ei ole pipeline hindamiseks vaja head meditsiinilist haridust - selleks on olemas analüütikud, kes teevad musta töö ära. Bilansi uurimine ei anna ka erilist tulemust, kuna kõik on rajatud ootustele ehk approvalitele ning finantsaruanded on USA's nagu nad on - pro forma you know :) IMHO. Ainuke asi, mida tasub vaadata on rahakäibe aruanne ja likviidsete vahendite hulk.
Mind huvitab, mida vaadata fundamentaalist? Ise vaatan ainult PEG'i.
Optsiooni fännidele ka väike küsimus :) Kas keegi on proovinud enne panel'i otsust osta straddle't ja kas see ära ka tasub. Biogen'I puhul oleks tasunud, kui oleks 2-3 päeva ennem ostnud. 1 päev ennem enam ei oleks tasunud.
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kas mõnda uuemat industry overviewd ei ole kellegi lauanurga peal?
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Täna oodatakse MedImmune(MEDI) kylmarohu FluMist kohta FDA otsust:
variante on kolm:
I approval
II non-approval
III complete response (letter) - CRL
esimene tõstab kõvasti aktsiahinda nagu ka II variant kukutab, sest Flumist peaks mõjutama firma tulusid 10-15% võrra
analüütikud ootavad III variandi realiseerumist, mis muudab turureaktsiooni segaseks
CRL on kolm taset:
unclassified, mis tähendab, et asi vaadatakse üle 2 nädala jooksul
class 1 - 2kuu pärast
class 2 - 6kuu pärast
ilmselt mida kiiremini taotlus uuesti läbi vaadatakse seda positiivsem mõju aktsia hinnale -
Medi liikus pärast CRL 22>26 ni
Täna saab näha, mida teeb Amgeni(AMGN) aktsia kui tuleb FDA otsus Aranespi kasutamise kohta vähi taastusravis (vähihaiged saavad kemoteraapiat, mis rikub vere ära. Aranespi soovitakse kasutada vere parendamiseks) -
Ootaks, et JNJ hüppab, kui AMGN saab negatiivse otsuse. JNJ Eprex on Aranespi peamine konkurent. (samas ei ootaks, et JNJ eriti kukuks kui AMGN saab positiivse otsuse osaliseks.)
Samas on huvitav see, et Aranesp saab konkurendiks ka JNJ Procritile, mida AMGN ise JNJ jaoks toodab. Jään huviga tänast uudist ootama. -
Kas mitte ei sõltu sektori lähitulevik Aranespi otsusest. Amgen omab väga head reputatsiooni ning kui juba Amgen ei suuda saada FDA approvalit, kes siis veel saab - Selline küsimus võib pärast neg. otsust investoritel peas mõlkuda?
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aranespi läheb ju ikka müügiks - vaata või suusaässasid (võib-olla annaks patustajaid aranespi reklaamis kasutada:))
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Kui ainult lund rohkem oleks:)
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Amgen on vaatamata turu nõrkusele tugev ning käive on ka suur juba.
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The Industry Handbook: Biotechnology
The Columbia Encyclopedia defines biotechnology as "the use of biological processes, as through the exploitation and manipulation of living organisms or biological systems, in the development or manufacture of a product or in the technological solution to a problem." Since the discovery of DNA (short for Deoxyribonucleic Acid) in 1953, and the identification of DNA as the genetic material in all life, there have been tremendous advances in the vast area of biotechnology. The discovery of DNA in 1953, however, was not the start of the biotech industry. In fact, most of today's basic purposes for biotechnology are the same as they were over 1000 years ago. Biotech has a wide range of uses including food alterations, genetic research and cloning, human and animal health care, pharmaceuticals, and the environment.
The biotech arena has not been without its controversy. In the 1970s researchers were forced to stop doing certain types of DNA experiments, and other countries banned the use of genetically modified agricultural products. More recently, we've seen the controversy over cloning as well as stem-cell research. Perhaps the biggest development in the biotechnology field (as far as investors go) occurred when, in the 1980s, the U.S. Supreme Court ruled to allow for patenting of genetically modified life forms. This means that intellectual property will always be at the forefront of biotechnology--some argue that the scope of patent protection actually defines the industry.
Because of extremely high research and development costs, coupled with very little revenue in the years of development, many biotechnology companies must partner with larger firms to complete product development. Over the past decade the biotech industry, with hundreds of smaller companies operating in it, has been dominated by a small handful of big companies; however, any one of these smaller companies can potentially produce a product that sends them soaring to the top.
Common Applications of Biotechnology:Agriculture
Improved foods, pest control, plant and animal disease control, improved food production.Industry
Oil/mineral recovery, environmental protection, waste reduction. Improved detergents, chemicals, stronger textiles.Health Care
Drugs, vaccines, gene therapy, tissue replacements.Research
Understanding the human genome and better detection of diseases.
There are still a lot of unknowns in biotechnology, but high profile analysts, politicians, and CEOs have all been quoted as stating that biotechnology is the future of health sciences. In a New York Times interview Bill Gates was quoted as saying, "people ask me what field I'd be in if not computers. I think I'd be working in biotechnology. I expect to see breathtaking advances in medicine over the next two decades, and biotechnology researchers and companies will be at the center of that progress."
Key Players:
Amgen - It focuses primarily on nephrology, cancer, inflammatory disorders, and metabolic and neurodegenerative diseases
Genentech - Its two largest products are lymphoma and breast cancer drugs.
Applera Corporation - It owns Applied Biosystems and Celera Genomics.Key Ratios/Terms
Food & Drug Administration (FDA) Approval ProcessPhase I (approx. 1 year) This is testing on 20-80 healthy individuals. The purpose of this phase is to determine the dosage and safety of the drug.
Phase II (approx. 1-3 years) As testing on 100-300 patients suffering from disease or condition, this phase mainly determines effectiveness and potential side effects.
Phase III (approx. 2-3 years) As testing on 1000-5000 patients suffering from disease or condition, this phase monitors side effects brought on by long-term usage. This stage is by far the most stringent and rigorous. Some of the patients receive the drug and the others receive a placebo (like a sugar pill) to determine effectiveness.Note: It has been estimated that only 1-2 out of 20 drugs that enter the FDA testing process actually gain final approval.
Research and Development (R&D) as a percentage of Sales = (R&D Expenditures)/(Revenue)
Generally speaking, the higher the percentage spent on R&D, the more there is being spent developing new products. Thus, the lower this is, the better. This ratio is useful when comparing one company to another or to the industry in general.Medicare/Medicaid
This is the U.S. national health insurance program, which is responsible for reimbursing individuals for certain health related costs. Any sudden changes in funding and reimbursement rates can have profound effects on the biotech industry.Orphan Drugs
These are drugs designed to treat people with rare diseases and infections (occurring in less than 200,000 individuals). Once the drugs are marketed to the public, orphan drug makers might not benefit from huge demand, but governments will usually subsidize many of the costs to producing these drugs.
Analyst Insight
Analyzing even a blue-chip company is no easy task. The job is even more difficult when the company in question has very little revenue and its livelihood hinges on one or two potential products. Like for analyzing any company, estimating earnings is key. Because of the long R&D phase with little revenue coming in, determining the prospective earnings of a biotech company is tricky. You can start by looking at the company's products in both development and production. For a company that is already selling products, looking at the sales trends makes it easy to determine the growth rates and market potential for the drug. For products "in the pipeline" you need to look at the disease that the drug/product intends to target and how large that market is. A drug that cures the common cold, cancer, or heart disease is more lucrative than an orphan drug targeting an obscure disease affecting less than 100,000 people in North America; furthermore, most analysts prefer companies who are developing treatments as opposed to vaccines.Treatment drugs are used continuously and repeatedly, whereas vaccines are a one time shot and not nearly as lucrative from a financial perspective (though no doubt important from a social perspective).
Ideally you want a company to have several products in development. That way, if one does not make it through the approval process, there are other products to balance the blow. At the same time, there is a happy medium between a company being too focused, and a company having so many developing ideas and products that it loses focus and spreads itself too thin.
Next, you want to take a look at is how far the company's products are in the stages of clinical development, and how close the product is to FDA approval. All companies wishing to sell drugs and/or biotech products in the States require FDA approval. If a company is relatively new at the FDA process, you can expect it to take longer for them to gain approval. It is for this reason that many small biotech companies will partner with a larger, more experienced one. The difference of one year in gaining approval can mean millions of dollars.
As the key to any successful biotech company is solid financing, you also must consider from where the company is getting its money. Take a look under current assets on the balance sheet; the company should have plenty of cash. By looking at the current ratio/working capital ratio you should be able to determine whether they are cash stricken. Because ratios vary wildly across different industries, compare the ratios only to those of similar companies within the biotech industry. The reason for the variation is that most biotech companies use equity financing instead of borrowing, partly because equity is cheaper and partly because many banks and creditors usually refuse to finance such high risk ventures for which there is a gross lack of collateral.
The other question you need to answer: where is the money being spent? Research and development should be the answer. Most biotech firms spend a majority of their money on R&D of new products. Some believe that the more a company spends on R&D, the better the company. Even more important, however, is finding a company that does a lot of research while still controlling expenses to make cash last years ahead. For companies with sales, the process is a little easier: you can look at R&D expenditures in relation to revenue, employees, or some other measure, and then compare it to similar biotech firms. This gives insight into how frugal the company is with their money.
For considering investing in biotech, doing a simple stock screen based on earnings, revenue, or some other financial figure might not uncover the diamond in the rough. You need to research the potential market for a drug, determine whether there are competitive products, and most importantly, predict whether the product will gain final approval. This doesn't mean you need to be a doctor to analyze a biotech stock, but you do need to understand the area of biotechnology in which the company is situated, and whether or not the risk of investing in the company is worth the reward.
Porter's 5 Forces Analysis (Learn More)
1. Threat of New Entrants - Because the biotech industry is filled with lots of small companies trying to hit the jackpot, the barriers to enter this industry are enough to scare away all but the serious companies. Biotech firms require huge amounts of funding to finance their large R&D budgets. Having ample cash is one of the biggest barriers, so when interest rates are low, or the equity markets are receptive to initial public offerings, the barriers are lower. Specialization also creates barriers. For instance, knowledge about cancer and heart disease is quite high, whereas a company focusing on methemoglobinemia would likely have a low threat of new entrants because there are very few experts in this field.2. Power of Suppliers - Biotech companies are unique because most of their value is driven from intellectual property. The nature of their business does not force them, unlike other industries, to rely on suppliers. Scientific tools, materials, computers, and testing equipment is highly specialized, but the likelihood of these companies invading on their line of business is not very high. One snag is that marketing alliances have often proven to be problematic. Small biotech firms don't have the distribution capabilities to promote their new drugs, so they are forced to license their drugs to other suppliers.
3. Power of Buyers - The bargaining power of customers tends has different levels in the biotech arena. For example, a company that sells pharmaceutical drugs has thousands of individuals as their customers and doesn't need to worry too much about a buyer revolt. After all, when is the last time you were able to bargain with the pharmacist for a better deal? On the other side are the biotech firms who sell highly specialized products to governments and hospitals. These large organizations have a lot more bargaining power with biotech companies.
4. Availability of Substitutes - The threat of substitutes in the biotechnology field, again, really depends on the area. While patent protection might stop the threat of alternative drugs and chemicals for a period of time, eventually there will be a company that can produce a similar product at a cheaper price. Generic drugs, for instance, are a problem: a company which spends millions of dollars on the creation of a new drug must sell it at a high price to recoup the R&D costs, but then along comes a generic drug maker who simply copies the formula and sells it for a fraction of the cost. This is big problem in foreign countries where there is a lack of government control.
Organizations will illegally produce patent protected drugs and sell them at much lower prices.
5. Competitive Rivalry - There are over 1,000 biotech companies operating in North America. With the top 1% of these companies making up a majority of the revenue, it's a tough industry to make a mark. The fight to see who can cure a disease or condition has researchers work day and night. Trade secrets are also extremely valuable. In short, the rivalry is extremely intense!
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WASHINGTON (Reuters Health) - The US Food and Drug Administration (FDA) said Thursday that it has cleared for marketing a rapid HIV test that government officials said could revolutionize the battle against the virus that causes AIDS.
The OraQuick Rapid HIV-1 Antibody Test requires only a drop of blood and can give accurate results in as little as 20 minutes. That's an improvement over tests used widely now, which require complex analysis that can take up to 2 weeks for results, said Secretary of the Department of Health and Human Services, Tommy Thompson.
"It's simple, accurate and very fast," said Thompson, who announced the FDA's decision at a Washington, DC news conference. "Countless more Americans will be able to learn their HIV status."
About 950,000 people in the US are HIV infected, but one in every four is unaware they have the virus, Thompson said, making an easier test that can be widely used an important public health tool. Efforts to stem the AIDS epidemic are now focusing both on preventing new cases of the disease as well as keeping those with the virus from spreading HIV, an endeavor that should be made easier with OraQuick.
FDA and National Institutes of Health officials said that the approval will overcome one of the most daunting problems with the current state of HIV testing--the lag between the test and the results. The lag time not only drives patients to avoid testing altogether, but about 8,000 patients a year are tested but never return for their results.
"We have a problem with some of the tests we have now--there's a wait of up to 14 days," said Murray Lumpkin, the senior associate commissioner at the FDA. "Having this test will address this kind of situation."
Lumpkin noted that the test appears more than 99% accurate, both in spotting positive results and in identifying negative results. The test's lone drawback is that because it detects a protein made by the body in response to the virus, not the virus itself, it may take as long as 3 months after infection for the OraQuick test to come back positive.
There is another FDA-approved rapid HIV test, but the product needs to be refrigerated before use and requires blood to be drawn from a vein. The OraQuick test needs no refrigeration, and the blood can be obtained from a single finger stick similar to those used in blood-donation screening.
The test can now only be used by experienced technicians in certified laboratories, but Thompson and Lumpkin urged OraQuick's maker to apply for a waiver that would allow wider use of the test.
The company that makes the product, OraSure Technologies, specializes in diagnostic tests. OraQuick will be distributed by medical product giant Abbott Laboratories. -
S6ren, et anda su viimasele s6numile jumet, siis kirjeldan, mis juhtus syndmusega seotud aktsiatega
HHS SAYS US FDA APPROVES ORASURE, ABBOTT ORAQUICK HIV TEST
(Reuters 11/07 13:02:43)
OSUR 5.72 t6usis 7 minutiga 6.50 -ni
ABT liikus aga suures nihkes ja hyppas alles kl. 13:15 45.39>45.57 ja seej2rel t6usis paarikymne minuti jooksul 45.89-ni -
jah, ma ei viitsinud ise otsida. eks see mõjutab turgu kaugemaski perspektiivis.
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Ärge siis arvake, et biotechidega ainult pappi kokku aetakse. Tavaliselt tuuakse esile ainult võitjaid, kuid väga tihti juhtub ka nii:
ARYX Therapeutics May file for bankruptcy, to wind down operations immediately after FDA announced additional delay
- The FDA has informed the company of an additional delay in providing needed guidance on the Phase 3 development of ARYxs product candidate for the treatment of various gastrointestinal disorders, naronapride. In this latest communication with ARYx, the FDA suggests a response will not be forthcoming until July 2011 at the earliest -
Huvist biotehnoloogia vastu... New Scientist ja Statoili ideevõistluse (lühikirjeldus järgmist 30 aastat kõige rohkem muutva tehnoloogiast) finaali on sadadest ideedest valitud välja viis finalisti. Ma oleksin ennustanud (tänu esitatud ideede hulgale ning ka Statoili taustale) vähemalt poole osas energia või vähemalt geoengineeringu ideid, siis valitud 5 on minu jaoks üllatavalt tugevalt biotehnoloogia ja üldiselt inimese poole kaldu.
