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Guided Therapeutics seeks premarket approval from FDA for LuViva Advanced Cervical Scan

Guided Therapeutics, Inc. today announced that it met with the Food and Drug Administration (FDA) on July 20, 2012. The company believes the meeting was very positive and plans to work with FDA to finalize the path forward to gain premarket approval (PMA) for the LuViva Advanced Cervical Scan, a non-invasive device used to detect cervical disease that leads to cancer, instantly and at the point of care.

26 Jul 2012

CAP/ASCCP LAST Project recommendations for better diagnosis of HPV-associated lesions

The College of American Pathologists (CAP) and the American Society for Colposcopy and Cervical Pathology (ASCCP) jointly issued The Lower Anogenital Squamous Terminology (LAST) Standardization Project for HPV-Associated Lesions: Background and Consensus Recommendations.

4 Jul 2012

New guidelines on cervical cancer screening

Many women over the last few decades have gone in for their Pap smear tests each year. Now, two influential groups of medical experts say that having cervical cancer screening once a year is not necessary and, in fact, should be discouraged. Many women can wait as long as five years between screenings, the new guidelines say.

15 Mar 2012

ACS, ASCCP and ASCP release new screening guidelines for cervical cancer

The American Cancer Society (ACS), the American Society for Colposcopy and Cervical Pathology (ASCCP), and the American Society for Clinical Pathology (ASCP) have released new guidelines for the prevention and early detection of cervical cancer.

15 Mar 2012

HPV and smear tests offer more effective approach for cervical screening

Testing for the human papillomavirus (HPV) - a virus most women will encounter at some point in their lives - followed by a smear test if they are HPV positive, provides the most effective approach for cervical screening, new research shows today.

1 Mar 2012

Guided Therapeutics seeks CE Mark approval for LuViva Advanced Cervical Scan

Guided Therapeutics, Inc. today announced that it has submitted the application for CE Mark approval for LuViva Advanced Cervical Scan. The CE Mark is required to market LuViva in the 27 nations that comprise the European Union (EU).

23 Jan 2012

Polarized filter may improve ability to detect precancerous changes, reduce unnecessary biopsies

The same filtered light that enables sunglasses to reduce glare may improve a physician's ability to detect early signs of cervical cancer, reducing unnecessary biopsies and surgery.

30 Nov 2011

New guidelines for prevention and early detection of cervical cancer

The American Cancer Society (ACS), the American Society for Colposcopy and Cervical Pathology (ASCCP), and the American Society for Clinical Pathology (ASCP) have proposed new guidelines for the prevention and early detection of cervical cancer.

20 Oct 2011

HPV testing for cervical screening saves women from more invasive tests

Testing for the human papillomavirus (HPV) as part of cervical screening reduces the number of women unnecessarily going on for further tests by over a third, new research shows today.

28 Sep 2011

Fewer doses of Cervarix vaccine may be as efficacious as standard three-dose regimen

Fewer than three doses of the human papillomavirus (HPV) vaccine Cervarix may be just as effective as the standard three-dose regimen when it comes to preventive measures against cervical cancer, according to a new study published September 9 in the Journal of the National Cancer Institute.

9 Sep 2011

Repeat HPV testing would reduce unnecessary treatment for women

Doing the human papillomavirus (HPV) test twice with a short interval between tests would reduce the number of women having unnecessary treatment, new research shows.

24 Aug 2011

mtm’s p16 and Ki-67 dual staining test identifies high-grade cervical disease in women with ASC-US and LSIL

mtm laboratories, a privately held diagnostics company developing, manufacturing and globally commercializing in vitro diagnostics for cervical cancer early detection and diagnosis, today announced the publication of a new paper showing that dual staining for p16 and Ki-67 can pinpoint the underlying high-grade cervical disease with a high degree of sensitivity and specificity in women with ASC-US or LSIL cytology results.

31 Mar 2011

Scientists receive AACR Team Science Award for HPV research

The Fifth Annual AACR Team Science Award will be given to a team of internationally renowned molecular biologists, epidemiologists, biostatisticians and clinicians from Fred Hutchinson Cancer Research Center and University of Washington who have worked together on human papillomavirus for more than 20 years.

28 Mar 2011

International research team receives AACR award for innovative, meritorious science

8 Feb 2011

FDA clears STI Medical Systems' ImageSense technology for use in colposcopy

STI Medical Systems, an industry leader in medical imaging systems and machine vision software, announced today that the U.S. Food and Drug Administration has given clearance to the Company's precedent-setting ImageSense technology for use in colposcopy.

6 Jan 2011

FDA accepts to file PMA application for LightTouch Cervical Scanner

Guided Therapeutics, Inc. announced that it was notified by the U.S. Food and Drug Administration (FDA) that the company's premarket approval application (PMA) for the LightTouch Cervical Scanner, for patients at risk for cervical cancer, is suitable for filing.

3 Dec 2010

Gen-Probe's APTIMA HPV assay effective for cervical cancer screening: FASE study

In a study published today in the International Journal of Cancer, Gen-Probe's APTIMA HPV Assay provided a better combination of sensitivity and specificity than HPV DNA- or cytology-based tests for cervical cancer screening.

18 Nov 2010

S.A.N.E. Vax calls for federal approval of reliable HPV genotyping test in cervical cancer prevention programs

In a letter addressed to Dr. Harold E. Varmus, director of the NCI, and Dr. Margaret Hamburg, FDA commissioner, Ms. Norma Erickson, president of S.A.N.E. Vax, Inc., requested that these two federal agencies recommend a reliable human papillomavirus (HPV) genotyping test to support the national virology-based cervical cancer prevention program for patient care. Erickson stated: "The NCI knows reliable HPV genotyping is based on using a PCR system with short target sequencing."

9 Nov 2010

S.A.N.E. Vax requests temporary suspension of Gardasil sales as cervical cancer preventive

In a letter addressed to Dr. Margaret Hamburg, the FDA commissioner, Ms. Norma Erickson, president of S.A.N.E. Vax, Inc. stated her research team has revealed the fact that in November 2001 the VRBPAC (Vaccines and Related Biological Products Advisory Committee) mistakenly allowed the vaccine manufacturer to use "CIN 2/3, AIS, or cervical cancer; i.e. CIN 2/3 or worse by histology- with virology to determine the associated HPV type- as the primary endpoint in the evaluation of a vaccine to prevent cervical cancer."

25 Oct 2010

Annual conventional Pap smear is cost effective to reduce cancer incidence and mortality

A study of the options for reducing cancer incidence and mortality among women who have been treated for precancerous cervical lesions found that an annual conventional Pap smear is a cost effective strategy.

21 Oct 2010