FDA approves first DNA test for two types of HPV

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Mar 15 2009

The U.S. Food and Drug Administration has approved the first DNA test that identifies the two types of human papillomavirus (HPV) that cause the majority of cervical cancers among women in the United States.

The test, called Cervista HPV 16/18, detects the DNA sequences for HPV type 16 and HPV type 18 in cervical cells. Differentiating these HPV types gives health care professionals more information on a patient’s risk of subsequently developing cervical cancer.

A positive Cervista 16/18 test result indicates whether HPV type 16, 18 or both types are present in the cervical sample.

The FDA also approved yesterday the Cervista HPV HR test, which is the second DNA test that detects essentially all of the high-risk HPV types in cervical cell samples. The Cervista HPV HR test uses a method similar to the Cervista HPV 16/18 test to detect the DNA sequences of these HPV types.

In women age 30 and older or women with borderline cytology, the Cervista HPV 16/18 test can be used together with cytology and the Cervista HPV HR test to assess risk of cervical disease.

“Results from these two tests, when considered with a physician’s assessment of the patient’s history, other risk factors, and professional guidelines, can help physicians better determine risk and could lead to better patient management,” said Daniel G. Schultz, M.D., director of the FDA’s Center for Devices and Radiological Health.

HPV is the most common sexually transmitted infection in the United States. The U.S. Centers for Disease Control and Prevention estimates that more than 6 million Americans become infected with genital HPV each year and that more than half of all sexually active women and men become infected at some time in their lives.

For most women, the body's own defense system clears the virus and infected women do not develop related health problems. However, some HPV types can cause cell abnormalities on the lining of the cervix that later can become malignant. While there are many different types of HPV, types 16 and 18 cause about 70 percent of all cervical cancers.

Cervista HPV 16/18 and Cervista HPV HR are manufactured by Madison, Wis.-based Third Wave Technologies.

Source:

http://www.fda.gov

Posted in: Pharmaceutical News

Tags: B Cell, Cancer, Cell, Cervical Cancer, Cervix, Cytology, DNA, Food, Health Care, Human Papillomavirus (HPV), Malignant, T-Cell, Virology, Virus

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DNA of pathogenic antigens

Nguyen Xuan Hoan says:

October 19, 2009 at 5:25 AM

Hi, I'm Mr Hoan, I am working in the research and development department of Viet A Technology Corporation in Vietnam.
Now, we need some DNA samples of pathogenic antigens to do some biological research projects in Vietnam. Our experiment is polymerase chain reactions, so we need some pathogenic antigens that are positive samples. Unfortunately, We don’t have enough positive DNA samples of pathogenic antigens for our experiment and we can’t find anywhere to purchase these products. I think you can produce these pathogenic antigens and provide them for us.
We want to purchase some DNA samples of the pathogenic antigens products in human, including:
−  The positive HPV specimen
−  The positive HBV specimen
−  Lamivudine-resistant rtM204I/V HBV, Lamivudine-resistant rtM180L HBV.
−  Adefovir-resistant rtN236T HBV, Adefovir-resistant rtA181T/V HBV
−  The positive HCV specimen
−  HPV genotype high risk (16, 18, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68, 82) and low risk (6, 11, 42, 43, 61, 70, 71, 78)
−  HBV genotype A, B, C
−  HCV genotype 3
−  The positive CMV specimen.
−  The positive specimen of  Isoniazid-resistant M. tuberculosis in mutant codon 315 of katG gene.
−  The positive specimen of  Rifampin-resistant M. tuberculosis in mutant condon 516, 526, 531 of rpoB gene
−  The positive specimen of  Ethambutal-resistant M. tuberculosis in mutant codon 306 of embB gene

We also want to purchase some DNA samples of the pathogenic antigens in shrimp or fish, including:
−  The positive WSSV (White spot syndrome virus) specimen
−  The positive shrimp HPV (Hepatopancreatic  Parvo-like  virus) specimen
−  The positive YHV specimen
−  The positive TSV specimen
−  The positive IHHNV (infectious Hypodermal  and  Haematopoietic  Necrosis) specimen
−  The positive MBV(Nonodon Baculo Virus) specimen
−  The positive NNV (Nervous Necrosis virus) specimen
Please, supply us with these products if you have one.
Actually, We have succeeded in the detection of pathogenic antigens in human and shrimp or fish by PCR technique.
Now, we want to apply this successful to production process kit for the purpose of diagnosis in human and shrimp or fish. We have commercialized these products in heath sector. So, We need a manufacturer to provide us with these pathogenic antigens that are positive specimens in polymerase chain reactions.
Please let us know the price of each product that we want to purchase,  and let us know how to pay the bill.
Sure, We will cooperate with the manufacturer for long time in future, so you don’t hesitate to produce these pathogenic antigens to provide us.
Thank you for your cooperation.
Please, contact us by email: [email protected] or [email protected]

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