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   Biotech / MedicalGuided Therapeutics - GTHP


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From: caly3/7/2011 9:46:00 AM
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Guided Therapeutics Granted Approval for Human Clinical Studies of Light-based Test for Barrett’s Esophagus Pipeline Product
Institutional Review Board rules test is non-significant risk to patients

GTHP.OB 1.33 0.00

Press Release Source: Guided Therapeutics, Inc. On Monday March 7, 2011, 8:30 am EST

NORCROSS, Ga.--(BUSINESS WIRE)-- Guided Therapeutics, Inc. (OTCBB & OTCQB: GTHP), developer of a rapid and painless testing platform that uses biophotonics for the early detection of disease, today announced that it has received Institutional Review Board (IRB) approval to begin testing its light-based detection technology in humans for Barrett’s Esophagus, a precursor for esophageal cancer. The IRB also categorized the technology as “non-significant risk,” which indicates the technology is fundamentally safe when used as directed.

“We are excited to move ahead with the second product based on our patented light-based, disease detection platform,” said Mark L. Faupel, CEO and president of Guided Therapeutics, Inc. “Receiving IRB approval, as well as being classified as “non-significant risk,” are both very important achievements for advancing this product extension. Our next milestones will be to complete the development of our prototypes and begin the first clinical study, which we expect to initiate in the second or third quarter of 2011.”

The new product for the detection of Barrett’s Esophagus, a precursor for esophageal cancer, is being co-developed with Konica Minolta Opto, Inc. of Japan and is based on the company’s LightTouch™ non-invasive cervical cancer detection technology, which is undergoing the U.S. Food and Drug Administration’s premarket approval process.

According to the World Health Organization (WHO), esophageal cancer ranks just below cervical cancer in newly diagnosed cases. New cases of esophageal cancer are estimated at 410,000 worldwide, with more than 16,000 new cases a year and more than 14,000 deaths in the U.S. alone. Barrett’s esophagus is believed to be caused by excessive acid reflux.

About The Technology Platform

The LightTouch disease detection platform, which consists of a base unit and single-patient-use calibration disposable, scans tissue with light to identify cancer and pre-cancer painlessly and non-invasively. The proprietary, patented biophotonic technology is able to distinguish between normal and diseased tissue by detecting biochemical and morphological changes at the cellular level. Unlike traditional tests, the Guided Therapeutics test does not require laboratory analysis or a tissue sample, is designed to provide results immediately and eliminate costly unnecessary testing.

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From: caly3/7/2011 10:37:08 AM
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And the reason for the dump today...

Guided Therapeutics Provides Update on FDA PMA Review of Cervical Cancer Test

Guided Therapeutics, Inc. (OTCBB & OTCQB: GTHP), today provided an update on the U.S. Food and Drug Administration (FDA) review process for its premarket approval application (PMA) for the LightTouch™ non-invasive test for the early detection of cervical pre-cancer. The PMA was accepted for filing as of September 23, 2010.

The FDA has inspected two clinical trial sites as part of its review process and raised no formal compliance issues. Advanced Scientifics, Inc. (ASI), the manufacturer of the Company’s single-patient-use disposable patient interface, also reported a successful FDA inspection.

As is typical in the FDA review process, the Company also received a series of questions from the FDA regarding the PMA, covering the clinical trial and various technical issues, for which the Company has 180 days to respond.

“We are pleased with the results of the FDA’s review of our clinical sites and that of our contract manufacturer, ASI,” said Mark L. Faupel, Ph.D., CEO and President of Guided Therapeutics, Inc. “We fully expect to answer the FDA’s questions in a timely manner. Given the timing of the FDA’s inspections and questions, though, it now appears less likely we will be part of the next Obstetrics and Gynecology Devices Panel meeting, tentatively scheduled for May 19-20, 2011.

“Still, we believe it is possible to meet our target for a year end 2011 or early 2012 launch in the U.S. with the next currently scheduled panel meeting date in September, 2011. This would assume the FDA’s questions are answered successfully, any additional inspections also are successful and final approval is granted. Meanwhile, we also continue to work toward an international launch, which could occur prior to approval in the U.S.,” Dr. Faupel said.

About The LightTouch™

The LightTouch, which consists of a base unit and single-patient-use calibration disposable, scans the cervix with light to identify cancer and pre-cancer painlessly and non-invasively. Guided Therapeutics’ patented biophotonic technology is able to distinguish between normal and diseased tissue by detecting biochemical and morphological changes at the cellular level. Unlike Pap or HPV tests, the LightTouch test does not require laboratory analysis or a tissue sample, is designed to provide results immediately and eliminate costly unnecessary testing.

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From: caly3/27/2011 10:14:58 AM
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The previously scheduled May meeting of the FDA's Ob/Gyn Devices Advisory Panel is now gone from the schedule and has been replaced by a Sept. 22-23 meeting.

fda.gov

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To: caly who wrote (94)3/30/2011 12:48:14 PM
From: caly
   of 118
 
Konica Minolta Opto, Inc. Extends Product Development Licensing Agreement with $750,000 Payment to Guided Therapeutics

Press Release Source: Guided Therapeutics, Inc. On Wednesday March 30, 2011, 9:05 am EDT

NORCROSS, Ga.--(BUSINESS WIRE)-- Guided Therapeutics, Inc. (OTCBB & OTCQB: GTHP), developer of a rapid and painless biophotonic testing platform for the early detection of disease, today announced that Konica Minolta Opto, Inc. of Tokyo has extended its licensing agreement to co-develop non-invasive cancer detection products.

Under terms of the agreement, Konica Minolta Opto will pay Guided Therapeutics a $750,000 fee to extend the agreement for one year. This is in addition to approximately $1.7 million the company expects to receive, over the course of the next 12 months, for the co-development of its first product in conjunction with Konica Minolta Opto for the detection and monitoring of esophageal pre-cancer called Barrett’s esophagus.

The products being developed with Konica Minolta Opto are based on the company’s non-invasive cervical disease detection technology, which is undergoing the U.S. Food and Drug Administration’s premarket approval process. In addition to the Barrett’s esophagus product, Konica Minolta Opto retains the rights to apply the technology to lung cancer.

“We continue to enjoy a strong working relationship with Konica Minolta Opto and believe that the continuation of our licensing agreement will likely lead to the first product line extension to be built upon our non-invasive cancer scanning platform technology,” said Mark L. Faupel, Ph.D., President and CEO of Guided Therapeutics, Inc. “With the recent approval to begin human clinical studies, we expect to begin enrolling subjects in the second or third quarter of this year, which will be a key milestone for the company.”

“We are pleased to continue our relationship with Guided Therapeutics to co-develop and market non-invasive cancer detection products,” said Akira Suzuki, General Manager, LC Business Department for Konica Minolta Opto. “We believe that these new technologies have the potential to improve the early detection of disease which is proven to save lives.”

According to the World Health Organization (WHO), esophageal cancer ranks just below cervical cancer in newly diagnosed cases. New cases of esophageal cancer are estimated at 410,000 worldwide, with more than 16,000 new cases a year and more than 14,000 deaths in the U.S. alone. Barrett’s esophagus is believed to be caused by excessive acid reflux.

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From: caly4/25/2011 12:56:59 AM
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atlanta.citybizlist.com

Posted April 24, 2011

By Richard Rabicoff

NORCROSS -- Steven Derby and his SDS Capital Management, LLC reported that they own 180,403 shares or 0.39 percent of Guided Therapeutics, Inc. (OTCBB and OTCQB: GTHP).

The holdings are worth $162,362 at the Guided Therapeutics Friday closing price of $0.90 per share.

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To: caly who wrote (96)4/26/2011 4:03:38 PM
From: Jeffrey Beckman
   of 118
 
Put a beard on him, and he's Conan O'Brien.

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To: Jeffrey Beckman who wrote (97)4/26/2011 5:02:07 PM
From: caly
   of 118
 
LOL! You're absolutely right. :)

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From: caly4/28/2011 11:40:32 AM
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Guided Therapeutics to Unveil Cervical Disease Detection Technology New Design and Branding at ACOG and EUROGIN Meetings
Principal investigators to present results of FDA clinical trials

Press Release Source: Guided Therapeutics, Inc. On Wednesday April 27, 2011, 9:05 am EDT

NORCROSS, Ga.--(BUSINESS WIRE)-- Guided Therapeutics, Inc. (OTCBB & OTCQB: GTHP), announced that it will present the new design and branding of its non-invasive and painless test for the early detection of cervical precancer at two upcoming international gynecology conferences. Additionally, attendees will be briefed on results of the pivotal clinical trial of the technology by two principal investigators.

“We are excited about the new design and branding for the cervical detection technology and believe it will be well received,” said Mark L. Faupel, Ph.D., CEO and President of Guided Therapeutics, Inc. “We are also pleased to have two of our principal investigators scheduled to present findings of our clinical trial to such prestigious medical conferences.”

Dr. Leo B. Twiggs, professor in the Department of Obstetrics and Gynecology at the University of Miami, Miller School of Medicine, is scheduled to present Study Results of a New Test for Cervical Dysplasia: Potential Impact on Patient Management, on Monday, May 2nd from 2 p.m. to 4 p.m. at The American College of Obstetricians and Gynecologists (ACOG) 59th Annual Clinical Meeting to be held April 30 - May 4, 2011 in Washington, DC. The company will display the design and brand at booth 621 beginning Monday, May 2nd.

Dr. Lisa Flowers, of Emory University and Grady Hospital of Atlanta, is scheduled to present Introducing a New Diagnostic Modality into the Standard of Care at the EUROGIN scientific meeting in Lisbon, Portugal on Tuesday, May 10th from 9:30 a.m. to 11:00 a.m. The company will display the design and brand at booth 4.13 beginning Sunday, May 8th.

The technology, which consists of a base unit and single-patient-use calibration disposable, scans the cervix with light to identify cancer and pre-cancer painlessly and non-invasively. Guided Therapeutics’ patented biophotonic technology is able to distinguish between normal and diseased tissue by detecting biochemical and morphological changes at the cellular level. Unlike Pap or HPV tests, the Guided Therapeutics test does not require laboratory analysis or a tissue sample, is designed to provide results immediately and eliminate costly unnecessary testing.

The technology is currently under U.S. Food and Drug Administration premarket approval review. In January 2011, Guided Therapeutics was awarded ISO 13485 certification for its quality system, a precursor for the CE mark required for sales in the European Union.

About ACOG

Founded in 1951 in Chicago, Illinois, ACOG has over 52,000 members and is the nation's leading group of professionals providing health care for women. Now based in Washington, DC, it is a private, voluntary, nonprofit membership organization. For more information, visit www.acog.org.

About EUROGIN

EUROGIN (EUropean Research Organisation on Genital Infection and Neoplasia) brings together clinicians and scientists whose work is related to genital infections and neoplasia. The aims of the organization are to promote and develop, at a European level, research, training, screening, prevention and information concerning genital infections, precancers and cancers in women. Developed as a result of a common European resolution, EUROGIN brings together representatives of all the specialist areas concerned: gynaecologists, dermatologists, pathologists, biologists, oncologists and basic scientists. For more information, visit www.eurogin.com/2011/.

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From: caly5/16/2011 4:00:02 PM
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10Q Filed:

sec.gov

LuViva™ (formerly LightTouch)

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From: caly5/18/2011 11:12:19 PM
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HPV test beats Pap for cervical cancer screening

news.yahoo.com

By MARILYNN MARCHIONE, AP Medical Writer – Wed May 18, 6:06 pm ET

Two big studies suggest possible new ways to screen healthy people for cervical or prostate cancers, but a third disappointed those hoping for a way to detect early signs of deadly ovarian tumors.

Researchers found:

_For women 30 and over, a test for the virus, HPV, is better than a Pap smear for predicting cervical cancer risk, and those who test negative on both can safely wait three years to be screened again.

_A single PSA blood test at ages 44 to 50 might help predict a man's risk of developing advanced prostate cancer or dying of it up to 30 years later. The PSA test is notoriously unreliable, but using it this way separates men who need a close watch from those who are so low-risk that they can skip testing for five years or more.

_Screening women with no symptoms for ovarian cancer with a blood test and an ultrasound exam is harmful. It didn't prevent deaths and led to thousands of false alarms, unneeded surgeries and serious complications.

The last study is a warning to people who get screening tests that aren't recommended, or who question whether screening can ever hurt.

"The answer is, it could hurt a lot," said Dr. Allen Lichter, chief executive of the American Society of Clinical Oncology. The group published these and 4,000 other studies Wednesday, ahead of its annual meeting next month.

Cervical cancer is easy to prevent. It's very slow-growing and screening finds precancerous cells and allows early treatment. The new study was the first big one to examine a newer screening tool, HPV tests, with or without Pap smears in routine practice.

For a Pap test, cells scraped from the cervix, the gateway to the uterus, are checked under a microscope. But this can miss problems or raise false alarms.

HPV tests detect the human papillomavirus, which causes most cases of cervical cancer. But HPV is "the common cold" of the nether regions — most sexually active young people have been exposed to it, said Debbie Saslow, the American Cancer Society's director of breast and gynecologic cancer. Most infections go away on their own; they're only a cancer risk when they last a year or more.

Younger women tend to have short-term infections, so Pap tests are a better way to screen them. HPV tests are approved as an option along with Paps for women 30 and older, and the cancer society says that if a woman tests negative on both, she can wait three years to be screened again. Few take this advice, though.

"Women still want their annual Pap and doctors still want to give them," and think it's rationing care to test less often, Saslow said.

The new study gives "very, very solid support" for screening less often, Lichter said.

Hormuzd Katki of the National Cancer Institute studied more than 330,000 women getting HPV and Pap tests through Kaiser Permanente Northern California for five years.

Only about three out of 100,000 women each year developed cervical cancer after negative HPV and Pap tests. HPV tests were twice as good as Paps for predicting risk. Adding a Pap after a negative HPV test did little to improve risk prediction.

However, if an HPV test was positive, a Pap test helped confirm or rule out the need for follow-up.

The study didn't look at the downside of HPV testing — how many false alarms and needless procedures it triggered. HPV tests cost $80 to $100 compared to $20 to $40 for Paps.

The prostate study sought a better way to use PSA tests, which are troublesome because PSA can be high for many reasons besides cancer, and doctors don't know which cancers need treatment or whether screening saves lives. Most groups don't recommend PSA tests, but most men over 50 get them anyway.
The new study "is not going to end the controversy, but it suggests a very interesting middle ground," Lichter said.
Researchers at Memorial Sloan-Kettering Cancer Center in New York used stored blood samples that 12,000 Swedish men gave for a heart study decades ago, when most were 44 to 50 years old. They also had second samples from some of them six years later, and samples from other 60-year-old men.

Looking 27 years later, researchers saw that 44 percent of cancer deaths occurred in men whose initial PSAs had been in the top 10 percent when they were 44 to 50 years old.
Conversely, scoring below the median meant very little cancer risk years later.

"They're identifying a group of guys who don't need to be screened, or need to be screened less often," said Dr. Otis Brawley, the cancer society's chief medical officer.
The results are "provocative," but this type of study can't prove that screening prevents deaths, said Dr. Matthew R. Smith of the Massachusetts General Hospital Cancer Center. Few of the Swedish men were treated for prostate cancer as most men are today, which can affect survival.

The National Cancer Institute, the Swedish Cancer Society and several foundations paid for the work, and one researcher holds patents for two PSA-related tests.

Baseline PSA tests for men in their 40s can't be recommended yet, Brawley said. The cancer society says men should be informed of the risks and benefits of PSA tests starting at age 50, and sooner for blacks and those with family history of prostate cancer.

The government-funded ovarian cancer study involved nearly 80,000 women. Half were screened annually with an ultrasound for four years and a blood test for six years. The blood test looked for CA-125, a substance often elevated in ovarian cancer.

After 13 years, there were no major differences in ovarian cancers found or deaths from the disease. Screening found only 212 cancers while giving 3,285 false alarms that led to 1,080 unneeded biopsy surgeries and 163 serious complications.
"So many people say `how can cancer screening be harmful?' This thing documents it," Brawley said.

The results don't apply to using these tests on women with symptoms of ovarian cancer or abnormal physical exams. That's still the best way to check for ovarian cancer in those cases.

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