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Guided Therapeutics (GTHP) 0.0595 $GTHP

Guided Therapeutics' Turkish Distributor Doubles Order for LuViva(R) Advanced Cervical Scan Single-Use Disposables for Turkish Ministry of Health
Business Wire - Wed Sep 09, 7:14AM CDT
Guided Therapeutics, Inc. (OTCQB: GTHP), the maker of a rapid and painless testing platform based on its patented biophotonic technology, announced today that its Turkish distributor, ITEM Medical Technologies, has received an increased order for disposable Cervical Guides from the Turkish Ministry of Health (MOH).

Guided Therapeutics Announces $550,000 Increase to $4 Million Private Placement and Accelerated Interim Closing
Business Wire - Thu Sep 03, 10:03AM CDT
Guided Therapeutics, Inc. (OTCQB: GTHP) announced today that it has entered into an amendment agreement to increase by $550,000 the gross cash proceeds from its previously announced private placement of convertible preferred stock and common stock warrants, as well as to accelerate the closing of $1.3 million of the total $4.55 million investment. Among those making the additional investment is a member of the Company's Board of Directors.

Guided Therapeutics Expands Access of the LuViva(R) Advanced Cervical Scan into Costa Rica
Business Wire - Tue Aug 25, 7:05AM CDT
Guided Therapeutics, Inc. (OTCQB: GTHP) announced today that access to the LuViva(R) Advanced Cervical Scan has been expanded to Costa Rica, bringing to 20 the number of countries where the Company has shipped its non-invasive, point-of-care cervical cancer detection technology.

Guided Therapeutics Submits Proposal to Kenya to Increase Cervical Cancer Screening Rates - Potential Screening Population of 12 Million Women
Business Wire - Thu Aug 20, 7:05AM CDT
Guided Therapeutics, Inc. (OTCQB: GTHP), in cooperation with its distributor, Stem World Enterprises, is working with the Kenyan National Ministry of Health (MOH) to help achieve First Lady Margret Kenyatta's Beyond Zero program goal of screening up to 12,000,000 Kenyan women for cervical cancer. President Uhuru Kenyatta himself has set a target of screening half the female population for cervical cancer each year.

Guided Therapeutics Advances LuViva PMA Application with FDA
Business Wire - Tue Aug 18, 7:05AM CDT
Guided Therapeutics, Inc. (OTCQB: GTHP) today announced that it has presented the U.S. Food and Drug Administration (FDA) with a plan for advancing the pre-market approval (PMA) application for the LuViva(R) Advanced Cervical Scan. In its "pre-submission" letter, the Company also requested a meeting with the agency to finalize the plan.

Strategies in the Global Tumor Marker Testing Market 2015 - Forecasts Sales of Major Tumor Markers by Country and Market Segment
M2 - Thu Aug 13, 10:24AM CDT
Research and Markets (http://www.researchandmarkets.com/research/vjr4qj/2015_strategies) has announced the addition of the "2015 Strategies in the Global Tumor Marker Testing Market: US, Europe, Japan" report to their offering. Highlights Identifies and evaluates major business opportunities emerging in the tumor marker market during the next five years. Examines trends in the U.S., Europe and Japan Reviews current and emerging tumor markers. Analyzes applications of emerging diagnostic technologies. Forecasts sales of major tumor markers by country and market segment. Profiles leading market players and potential entrants Companies Mentioned: - Abbott - AdnaGen - Agilent Technologies - Applied Gene Technologies - Arca/Nuvelo - Beckman Coulter/Danaher - Becton Dickinson - Biomedical Diagnostics - bioMerieux - Bio-Rad - CellSearch - Cepheid - Correlogic Systems/Vermillion - Decode - Diadexus - Diagnocure - Diasorin - Eiken Chemical - Epigenomics - Enterix - Enzo Biochem - Exact Sciences - Fujirebio/Innogenetics - Guided Therapeutics - Hologic/Gen-Probe - Kreatech - Kyowa Medex - Mackay Life Sciences - Myriad Genetics - Nanogen Elitech - OncoLab - Ortho-Clinical Diagnostics - Panacea Pharmaceuticals - Polartechnics For more information visit http://www.researchandmarkets.com/research/vj...strategies
MYGN: 38.46 (+0.07), ENZ: 3.04 (-0.03), A: 35.96 (+0.10), CPHD: 51.97 (+0.70), DHR: 86.84 (+0.79), HOLX: 40.11 (+0.72)

Guided Therapeutics Reports Second Quarter 2015 Financial Results; Closes $10 Million Deal
Business Wire - Wed Aug 12, 3:05PM CDT
--$10 million deal with Turkey Ministry of Health for cervical cancer screening

Guided Therapeutics Schedules Conference Call to Discuss Second Quarter 2015 Financial Results
Business Wire - Tue Aug 04, 1:02PM CDT
Guided Therapeutics, Inc. (OTCQB: GTHP), the maker of a rapid and painless testing platform based on its patented biophotonic technology, announced today that it will report its 2015 second quarter financial results following the market close on Wednesday, August 12, 2015. The Company has scheduled a conference call for Thursday, August 13, 2015 at 11:00 A.M. Eastern Time (ET) to review the results.

Guided Therapeutics' Distributor Signs New Four-year Deal to Sell $10 Million of LuViva(R) Advanced Cervical Scans to Turkish Ministry of Health
Business Wire - Tue Jul 28, 7:04AM CDT
Guided Therapeutics, Inc. (OTCQB: GTHP), the maker of a rapid and painless testing platform based on its patented biophotonic technology, announced today that its Turkish distributor, ITEM Medical Technologies, has been awarded a new, four-year contract to supply LuViva(R) Advanced Cervical Scans and single-use, disposable Screening Cervical Guides to the Turkish Ministry of Health (MOH). The contract will generate more than $10 million for Guided Therapeutics.

Guided Therapeutics Announces $4 Million Private Placement
Business Wire - Tue Jun 30, 7:30AM CDT
Guided Therapeutics, Inc. (OTCBB: GTHP) (OTCQB: GTHP) announced today that it has entered into a securities purchase agreement with certain accredited investors for the private placement of its convertible preferred stock and warrants to purchase shares of its common stock. Gross cash proceeds to the Company are expected to be approximately $4.0 million, prior to the payment of placement agent fees and expenses.

2015 Market Segmentation Analysis of the US Cancer Diagnostics Industry: Oncogenes, Biochemical Markers, Lymphokines, GFs, CSFs, Hormones, Immunohistochemical Stains--Hospitals, Commercial Labs, POC Locations
M2 - Mon Jun 29, 6:05AM CDT
Research and Markets (http://www.researchandmarkets.com/research/phj84s/2015_market) has announced the addition of the "2015 Market Segmentation Analysis of the US Cancer Diagnostics Industry: Oncogenes, Biochemical Markers, Lymphokines, GFs, CSFs, Hormones, Immunohistochemical Stains--Hospitals, Commercial Labs, POC Locations" report to their offering. 2015 Market Segmentation Analysis of the US Cancer Diagnostics Industry: Oncogenes, Biochemical Markers, Lymphokines, GFs, CSFs, Hormones, Immunohistochemical Stains--Hospitals, Commercial Labs, POC Locations is a new study of the major business opportunities emerging in the US cancer diagnostics market during the nextfive years. The report examines trends in the US market; reviews current and emerging assays; analyzes potential applications of new diagnostic technologies; forecasts sales of major tumor markers by market segment; profiles leading players and potential market entrants; and identifies specific business opportunities for suppliers. Rationale The cancer diagnostics market is on the verge of explosion, as the researchers approach major technological breakthroughs in tumor diagnosis and therapy, discover new specific antigens, and unlock the mystery of the genetic basis of the disease. During the next five years, the US cancer diagnostics market is promising to be an exciting, dynamic and rapidly expanding field. Anticipated technological breakthroughs will create numerous opportunities for determining genetic predisposition, detecting specific tumors, and monitoring biological response to cancer therapy. The rise in geriatric population will further compound the growing demand for malignancy assays and the rapid market expansion. US Market Overview - Five-year test volume and sales projections. - Comprehensive market segmentation analysis, including review of the market dynamics, structure, size, growth and major suppliers. - Estimated universe of laboratories performing cancer diagnostic testing. - Cancer statistics, etiology and recent developments in the US. Business Opportunities and Strategic Recommendations - Specific new product development opportunities with potentially significant market appeal during the next five years. - Design criteria for new products. - Alternative market penetration strategies. - Potential market entry barriers and risks. Over 200 Current and Emerging Cancer Diagnostic Test - Oncogenes - Biochemical Markers - Growth Factors - Colony Stimulating Factors - Hormones - Immunohistochemical Stains - Lymphokines Supplier Shares, Sales and Volume Forecasts - Sales and market shares of major cancer diagnostic product suppliers by individual test. - Five-year test volume and sales forecasts for major tumor markers by market segment, including: - Hospitals - Commercial/Private Laboratories - Physician Offices/Group Practices - Cancer Clinics - Ambulatory Care Centers Instrumentation Review - Analysis of major molecular diagnostic and immunodignostic analyzers used for cancer testing, including their operating characteristics, features and selling prices. Technology Assessment - Assessment of latest technologies and their potential applications for cancer diagnostic testing. - Review of competing/complementing technologies. - Extensive listings of companies, universities and research centers developing new cancer diagnostic tests and detection technologies. Competitive Strategies - Strategic assessments of major suppliers and start-up firms developing innovative cancer diagnostic technologies and products, including their sales, product portfolios, marketing tactics, collaborative arrangements, and new products in R&D. Companies Mentioned - Abbott - AdnaGen - Agilent Technologies - Applied Gene Technologies - Arca Pharma - Beckman Coulter/Danaher - Becton Dickinson - Biomedical Diagnostics - bioMerieux - Bio-Rad - CellSearch - Cepheid - Correlogic Systems/Vermillion - Epigenomics - Enterix - Enzo Biochem - Exact Sciences - Fujirebio - Guided Therapeutics - Hologic/Gen-Probe - Kreatech/Leica - Kyowa Medex - Mackay Life Sciences - Myriad Genetics - OncoLab - Ortho-Clinical Diagnostics - Panacea Pharmaceuticals - Polartechnics - Polymedco - PreMD - Veridex - Wako Pure Chemicals - Wallac/PE - Zilla For more information visit http://www.researchandmarkets.com/research/ph...015_market
MYGN: 38.46 (+0.07), ENZ: 3.04 (-0.03), A: 35.96 (+0.10), CPHD: 51.97 (+0.70), DHR: 86.84 (+0.79), HOLX: 40.11 (+0.72)

2015 Cancer Diagnostics: A Market on the Verge of Explosion--Technological Breakthroughs, Emerging Tests, Market Forecasts, Competitive Intelligence
M2 - Thu Jun 18, 12:14PM CDT
Research and Markets (http://www.researchandmarkets.com/research/x472n5/2015_cancer) has announced the addition of the "2015 Cancer Diagnostics: A Market on the Verge of Explosion--Technological Breakthroughs, Emerging Tests, Market Forecasts, Competitive Intelligence" report to their offering. The cancer diagnostics market is on the verge of explosion, as the researchers approach major technological breakthroughs in tumor diagnosis and therapy, discover new specific antigens, and unlock the mystery of the genetic basis of the disease.During the next five years, the worldwide cancer diagnostics market is promising to be an exciting, dynamic and rapidly expanding field.Anticipated technological breakthroughs will create numerous opportunities for determining genetic predisposition, detecting specific tumors, and monitoring biological response to cancer therapy.The rise in geriatric population will further compound the growing demand for malignancy assays and the rapid market expansion worldwide. Geographic Coverage France, Germany, Italy, Japan, Spain, UK, USA - The companies analyzed in the report include - Abbott - AdnaGen - Agilent Technologies - Applied Gene Technologies - Arca Pharma - Beckman Coulter/Danaher - Becton Dickinson - Biomedical Diagnostics - bioMerieux - Bio-Rad - CellSearch - Cepheid - Correlogic Systems/Vermillion - Decode Genetics - Diadexus - Diagnocure - Diasorin - Eiken Chemical - Elitech Group - Epigenomics - Enterix - Enzo Biochem - Exact Sciences - Fujirebio - Guided Therapeutics - Hologic/Gen-Probe - Kreatech/Leica - Kyowa Medex - Mackay Life Sciences - Myriad Genetics - OncoLab - Ortho-Clinical Diagnostics - Panacea Pharmaceuticals - Polartechnics - Polymedco - PreMD - Qiagen/Ipsogen - Quest Diagnostics - Radient Pharmaceuticals - Roche - Scienion - Sequenom - Siemens Healthcare - Takara Bio - Targeted Diagnostics & Therapeutics - Thermo Fisher - Tosoh - Veridex - Wako Pure Chemicals - Wallac/PE - Zila For more information visit http://www.researchandmarkets.com/research/x4...015_cancer About Research and Markets Research and Markets is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.
MYGN: 38.46 (+0.07), A: 35.96 (+0.10), DHR: 86.84 (+0.79), SQNM: 2.13 (-0.03), ENZ: 3.04 (-0.03), DGX: 65.62 (+0.16), CPHD: 51.97 (+0.70), HOLX: 40.11 (+0.72)

2015 New Frontiers in Cancer Diagnostics: Global Challenges, Emerging Technologies, Competitive Landscape
M2 - Wed Jun 10, 9:34AM CDT
Research and Markets (http://www.researchandmarkets.com/research/8s2gxv/2015_new) has announced the addition of the "2015 New Frontiers in Cancer Diagnostics: Global Challenges, Emerging Technologies, Competitive Landscape (Datapack)" database table to their offering. This is a new study of the major business opportunities emerging in the global cancer diagnostics market during the next five years. The report examines trends in the U.S., Europe and Japan; reviews current and emerging assays; analyzes potential applications of new diagnostic technologies; forecasts sales of major tumor markers by country and market segment; profiles leading players and potential market entrants; and identifies specific business opportunities for suppliers. Worldwide Market Overview: - Five-year test volume and sales projections by country. - Comprehensive market segmentation analysis, including review of the market dynamics, structure, size, growth and major suppliers by country. - Estimated universe of laboratories performing cancer diagnostic testing by country. - Cancer statistics, etiology and recent developments in the U.S., Europe, and Japan. Business Opportunities and Strategic Recommendations: - Specific new product development opportunities with potentially significant market appeal during the next five years. - Design criteria for new products. - Alternative market penetration strategies. - Potential market entry barriers and risks. Over 200 Current and Emerging Cancer Diagnostic Test - Biochemical Markers - Oncogenes - Growth Factors - Hormones - Colony Stimulating Factors - Lymphokines - Immunohistochemical Stains, and others. Companies Mentioned - Abbott - AdnaGen - Beckman Coulter/Danaher - Becton Dickinson - Biomedical Diagnostics - bioMerieux - Bio-Rad - Eiken Chemical - Elitech Group - Epigenomics - Enterix - Enzo Biochem - Exact Sciences - Fujirebio - Guided Therapeutics - Hologic/Gen-Probe - OncoLab - Ortho-Clinical Diagnostics - Panacea Pharmaceuticals - Polartechnics - Polymedco - PreMD - Qiagen/Ipsogen - Quest Diagnostics - Radient Pharmaceuticals - Roche - Takara Bio - Targeted Diagnostics & Therapeutics - Thermo Fisher - Tosoh - Veridex - Wako Pure Chemicals - Wallac/PE - Zilla For more information visit http://www.researchandmarkets.com/research/8s2gxv/2015_new
ENZ: 3.04 (-0.03), DGX: 65.62 (+0.16), DHR: 86.84 (+0.79), HOLX: 40.11 (+0.72)

2015 New Frontiers in the German Cancer Diagnostics Market: Business Challenges, Emerging Technologies, Competitive Landscape
M2 - Wed Jun 10, 9:34AM CDT
Research and Markets (http://www.researchandmarkets.com/research/njc9tc/2015_new) has announced the addition of the "2015 New Frontiers in the German Cancer Diagnostics Market: Business Challenges, Emerging Technologies, Competitive Landscape (Datapack)" database table to their offering. This is a new study of the major business opportunities emerging in the German cancer diagnostics market during the next five years. The report examines trends in the German cancer diagnostics markets, reviews current and emerging assays; analyzes potential applications of new diagnostic technologies; forecasts sales of major tumor markers by market segment; profiles leading players and potential market entrants; and identifies specific business opportunities for suppliers. German Market Overview: - Five-year test volume and sales projections. - Comprehensive market segmentation analysis, including review of the market dynamics, structure, size, growth and major suppliers. - Estimated universe of laboratories performing cancer diagnostic testing. - Cancer statistics, etiology and recent developments. Business Opportunities and Strategic Recommendations: - Specific new product development opportunities with potentially significant market appeal during the next five years. - Design criteria for new products. - Alternative market penetration strategies. - Potential market entry barriers and risks. Over 200 Current and Emerging Cancer Diagnostic Test: - Biochemical Markers - Oncogenes - Growth Factors - Hormones - Colony Stimulating Factors - Lymphokines - Immunohistochemical Stains, and others. Companies Mentioned - Abbott - AdnaGen/Alere - Agilent Technologies - Applied Gene Technologies - Arca Pharma - Beckman Coulter/Danaher - Becton Dickinson - Elitech Group - Epigenomics - Enterix - Enzo Biochem - Exact Sciences - Fujirebio - Guided Therapeutics - Hologic/Gen-Probe - Kreatech/Leica - Kyowa Medex - Mackay Life Sciences - Myriad Genetics - OncoLab - Ortho-Clinical Diagnostics - Panacea Pharmaceuticals - Polartechnics - Polymedco - PreMD - Targeted Diagnostics & Therapeutics - Thermo Fisher - Tosoh - Veridex - Wako Pure Chemicals - Wallac/PE - Zilla For more information visit http://www.researchandmarkets.com/research/njc9tc/2015_new
MYGN: 38.46 (+0.07), ENZ: 3.04 (-0.03), A: 35.96 (+0.10), DHR: 86.84 (+0.79), HOLX: 40.11 (+0.72)

2015 New Frontiers in the Italian Cancer Diagnostics Market: Business Challenges, Emerging Technologies, Competitive Landscape (Datapack)
M2 - Wed Jun 10, 9:29AM CDT
Research and Markets (http://www.researchandmarkets.com/research/t5ptkf/2015_new) has announced the addition of the "2015 New Frontiers in the Italian Cancer Diagnostics Market: Business Challenges, Emerging Technologies, Competitive Landscape (Datapack)" report to their offering. This is a new study of the major business opportunities emerging in the Italian cancer diagnostics market during the next five years. The report examines trends in the Italian cancer diagnostics markets, reviews current and emerging assays; analyzes potential applications of new diagnostic technologies; forecasts sales of major tumor markers by market segment; profiles leading players and potential market entrants; and identifies specific business opportunities for suppliers. Italian Market Overview: - Five-year test volume and sales projections. - Comprehensive market segmentation analysis, including review of the market dynamics, structure, size, growth and major suppliers. - Estimated universe of laboratories performing cancer diagnostic testing. - Cancer statistics, etiology and recent developments. Business Opportunities and Strategic Recommendations: - Specific new product development opportunities with potentially significant market appeal during the next five years. - Design criteria for new products. - Alternative market penetration strategies. - Potential market entry barriers and risks. Over 200 Current and Emerging Cancer Diagnostic Test: - Biochemical Markers - Oncogenes - Growth Factors - Hormones - Colony Stimulating Factors - Lymphokines - Immunohistochemical Stains, and others. Supplier Shares, Sales and Volume Forecasts: - Sales and market shares of major cancer diagnostic product suppliers by individual test. - Five-year test volume and sales forecasts for major tumor markers by market segment, including: - Hospitals - Commercial/Private Laboratories Instrumentation Review: - Analysis of major molecular diagnostic and immunodignostic analyzers used for cancer testing, including their operating characteristics, features and selling prices. Technology Assessment: - Assessment of latest molecular diagnostic methods, biochips/microarrays, biosensors, monoclonal antibodies, immunoassays, chromosome analysis, IT, artificial intelligence, flow cytometry, and other technologies and their potential applications for cancer diagnostic testing. - Review of competing/complementing technologies, including CT, MRI, NMR, PET and photonics spectroscopy. - Extensive listings of companies, universities and research centers developing new cancer diagnostic tests and detection technologies. Competitive Strategies: - Strategic assessments of major suppliers and start-up firms developing innovative technologies and products, including their sales, product portfolios, marketing tactics, collaborative arrangements, and new products in R&D. Companies Mentioned - Abbott - AdnaGen/Alere - Agilent Technologies - Applied Gene Technologies - Arca Pharma - Bckman Coulter/Danaher - Becton Dickinson - Biomedical Diagnostics - bioMerieux - Bio-Rad - CellSearch - Cepheid - Correlogic Systems/Vermillion - Decode Genetics - Diadexus - Diagnocure - Enzo Biochem - Exact Sciences - Fujirebio - Guided Therapeutics - Hologic/Gen-Probe - Kreatech/Leica - Kyowa Medex - Mackay Life Sciences - Polymedco - PreMD - Qiagen - Quest Diagnostics - Radient Pharmaceuticals - Roche - Scienion - Sequenom - Wako Pure Chemicals - Wallac/PE - Zilla For more information visit http://www.researchandmarkets.com/research/t5ptkf/2015_new
SQNM: 2.13 (-0.03), ENZ: 3.04 (-0.03), A: 35.96 (+0.10), DGX: 65.62 (+0.16), CPHD: 51.97 (+0.70), HOLX: 40.11 (+0.72)

Turkish Ministry of Health Expanding Usage of Guided Therapeutics' LuViva(R) Advanced Cervical Scan Driving Significant New Orders
Business Wire - Wed Jun 10, 8:26AM CDT
Guided Therapeutics, Inc. (OTCBB: GTHP) (OTCQB: GTHP) announced today that its Turkish distribution partner, ITEM Medical Technologies, has received a significant new order from the National Ministry of Health as it expands usage of the LuViva(R) Advanced Cervical Scan for screening in 2015. The new order of 100 LuViva devices and 100,000 single-use Cervical Guides supplements previous orders, and is also based in part on the Ministry of Health's acceptance of LuViva in government training centers and university hospitals. The orders are expected to be filled starting in October.

Guided Therapeutics Awarded Multiple Tenders for LuViva(R) Advanced Cervical Scan Systems from Governments in Bangladesh
Business Wire - Thu Jun 04, 7:30AM CDT
Guided Therapeutics, Inc. (OTCBB: GTHP) (OTCQB: GTHP) announced today that its distributor in Bangladesh has been awarded contracts for four additional LuViva(R) Advanced Cervical Scan systems for use in the country's cervical cancer screening program. The latest awards double the number of LuViva units purchased by various government agencies in Bangladesh to eight.

2015 Strategies in the Global Tumor Marker Testing Market
M2 - Fri May 29, 5:54AM CDT
Research and Markets (http://www.researchandmarkets.com/research/kj6pzz/2015_strategies) has announced the addition of the "2015 Strategies in the Global Tumor Marker Testing Market: US, Europe, Japan" report to their offering. Identifies and evaluates major business opportunities emerging in the tumor marker market during the next five yearsExamines trends in the U.S., Europe and JapanReviews current and emerging tumor markersAnalyzes applications of emerging diagnostic technologiesForecasts sales of major tumor markers by country and market segmentProfiles leading market players and potential entrants Companies Mentioned: - Abbott - Beckman Coulter/Danaher - Becton Dickinson - Biomedical Diagnostics - bioMerieux - Bio-Rad - CellSearch - Cepheid - Correlogic Systems/Vermillion - Decode - Diadexus - Diagnocure - Enzo Biochem - Guided Therapeutics - Hologic/Gen-Probe - Kreatech - Kyowa Medex - Mackay Life Sciences - Myriad Genetics - PreMD - Qiagen/Ipsogen - Quest Diagnostics - Radient Pharmaceuticals - Roche - Sequenom - Siemens Healthcare - Takara Bio - Targeted Diagnostics & Therapeutics - Tosoh - Thermo Fisher/Life Technologies - Veridex - Wako Pure Chemicals - Wallac/PE - Zila For more information visit http://www.researchandmarkets.com/research/kj...strategies
MYGN: 38.46 (+0.07), DHR: 86.84 (+0.79), SQNM: 2.13 (-0.03), ENZ: 3.04 (-0.03), DGX: 65.62 (+0.16), CPHD: 51.97 (+0.70), HOLX: 40.11 (+0.72)

Guided Therapeutics strikes out again with LuViva PMA
Seeking Alpha - at Seeking Alpha - Tue May 19, 5:10PM CDT


FDA Completes Review of Guided Therapeutics' LuViva(R) Advanced Cervical Scan PMA Application
Business Wire - Tue May 19, 3:05PM CDT
Guided Therapeutics, Inc. (OTCBB: GTHP) (OTCQB: GTHP) today announced that it has received notification from the U.S. Food and Drug Administration (FDA) regarding the pre-market approval (PMA) application for the LuViva(R) Advanced Cervical Scan. In its most recent communication, FDA advised the Company that its PMA amendment, filed in July 2014, was not approvable in its current form. While the agency advised the Company that more patient data would likely be necessary to amend the current application, the agency also stated its willingness to consider alternative approaches to move the product to approvable form.

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