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CLIA in Medical News

Abbott Receives FDA CLIA Waiver for Use of Five Additional Cartridges on the i-STAT Handheld Blood Analyzer

PRINCETON, N.J., Jan. 19 /PRNewswire-FirstCall/ -- Abbott announced today that the U.S. Food and Drug Administration (FDA) has granted waived status under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) for five additional test cartridges used by its i-STAT handheld blood analy...

Tethys Bioscience Hits Key Milestones With Series C Funding, Opening of CLIA Laboratory

Biomarker discovery company builds strong financial and clinical foundation in preparation for release of technology enabling early detection of risk for diabetes EMERYVILLE, Calif., Jan. 10 /PRNewswire/ -- Tethys Bioscience today announced that it has reached two s...

StatSure's Patented HIV 'Barrel' Technology Receives CLIA Waiver From FDA

FRAMINGHAM, Mass., Nov. 5 /PRNewswire-FirstCall/ -- StatSure Diagnostic Systems, Inc. (OTC Bulletin Board: SSUR.OB) announced today that the U.S. Food and Drug Administration ("FDA"), through its Center for Devices and Radiological Health, has approved a waiver under the Clinical Laboratory Im...

Abbott Broadens Use of i-STAT Handheld Blood Analyzer with CLIA Waiver Granted by FDA for CHEM8+ Test Cartridge

EAST WINDSOR, N.J., Oct. 2 /PRNewswire-FirstCall/ -- Abbott (NYSE: ABT ) announced today that the U.S. Food and Drug Administration (FDA) has granted waived status under the Clinical Laboratory Improvement Amendements of 1988 (CLIA) for its handheld i-STAT CHEM8+ test cartridge, making it mor...

Ridge Diagnostics Wins Growth-Promoting Loan From Biotech Center

...Carolina Biotechnology Center. The funds will further develop the company's clia certified laboratory in Research Triangle Park, thereby supporting the comm...tric disease diagnostics. Ridge Diagnostics' tests are provided through its clia certified laboratory in North Carolina, with plans for diagnostic test kits...

LeadConfirm Professional, the First Oral Based Lead Test, Makes Getting the Lead Out Easier - Now Available at Amazon.com

...ded in the kit and the results can be accessed online or by phone within 5-6 business days after the lab receives the kit. The tests are analyzed clia by state-of-the-art Liquid Chromatography (HPLC) with Mass Spectrometry X2 (LC/MS/MS) technology to determine the amount of lead present in the body. ...

LeadConfirm Professional Now Available at Overstock.com--The First Oral Based Lead Test Makes Getting the Lead Out Easier

...ded in the kit and the results can be accessed online or by phone within 5-6 business days after the lab receives the kit. The tests are analyzed clia by state-of-the-art Liquid Chromatography (HPLC) with Mass Spectrometry X2 (LC/MS/MS) technology to determine the amount of lead present in the body. ...

LeadConfirm Professional Now Available at Drugstore.com - The First Oral Based Lead Test, Makes Getting the Lead Out Easier

...ded in the kit and the results can be accessed online or by phone within 5-6 business days after the lab receives the kit. The tests are analyzed clia by state-of-the-art Liquid Chromatography (HPLC) with Mass Spectrometry X2 (LC/MS/MS) technology to determine the amount of lead present in the body. ...

Boston Heart Lab Named 'Most Promising Early Stage Company' 2009 by Silicom Ventures

...Navigator) based on the latest peer-reviewed scientific data. A privately held company, Boston Heart Lab began clinical operations after receiving its clia license in July 2008. Media Contact: Caroline Grossman - 781.771.5579 - caroline.grossman@gmail.com " target="_new"> caroline.grossman@gmail.co...

Frost & Sullivan Recognizes Singulex for Erenna(R) Immunoassay System

...ix, CEO. "Singulex is also building on its diagnostic business by offering our proprietary Molecular Cardiac Troponin-I (cTnI) testing services in our clia laboratory for early detection and monitoring of cardiovascular disease risk." The Erenna Immunoassay System is a simple, easy-to-use bench-top a...
CLIA in Medical Technology

First Molecular Tem-PCR Test to Identify Multiple Forms of Staph and MRSA Obtains CLIA Certificate

Identifies deadly hospital pathogens A single, fast and accurate test identifies four Staph strains simultaneously HUNTSVILLE, Ala., Aug. 4 /PRNewswire/ -- Diatherix Laboratories, an independent clinical reference laboratory located in the Huds...

Rosetta Genomics Signs Agreement With West Coast CLIA Certified Lab to Develop and Validate Tests Applying Company's MicroRNA Technology

Tests Will be Developed and Validated Clinically at Clinical Laboratory Improvement Amendments (CLIA) Certified Laboratory at the University of California, Irvine School of Medicine Rosetta Genomics Expects Three Tests Applying its MicroRNA Technology to be Developed and...

Ridge Diagnostics, Inc. Clinical Data on Blood Test for Depression Presented at American Psychiatric Association Annual Meeting

.... Ridge intends to develop a comprehensive neuropsychiatric disease diagnostic platform. Ridge Diagnostics testing services are provided through its clia certified laboratory in North Carolina, and it is developing a kit version for future distribution. The company is located in San Diego, CA and Resea...

Cepheid Announces European Release of First On-Demand Molecular Test for Simultaneous Detection of Mycobacterium tuberculosis (TB) and Resistance to Rifampicin

... reduces hands-on time to about one minute. This new test configuration is also expected to form the foundation for Cepheid's projected future line of clia waived products." Appropriate therapeutic management has been a significant factor in the development of drug resistant TB strains. Optimal manag...

Ridge Diagnostics, Inc. Awarded Phase 2 National Science Foundation Grant

...the company completed the commercial launch of its clia certified laboratory in Research Triangle Park, NC...al development of our blood tests and build on our clia laboratory infrastructure to support our growing b...gnostics testing services are provided through its clia certified laboratory in North Carolina, then throu...

Midwest Research Institute Launches Clinical Molecular Diagnostics Laboratory

... Receives clia Certification and CAP Accreditation PALM BAY,...on or clinical trials, has created a need for more clia certified laboratories with the capability for con... reagents. "MRI anticipated the need for more clia certified laboratories required to support diagnos...

Quest Diagnostics ClariSure(TM) Postnatal Molecular Test Receives Clinical Laboratory Approval from New York State

...ervices are regulated under the federal Clinical Laboratory Clinical Laboratory Improvement Amendments (CLIA). Laboratory-developed tests must fulfill clia requirements, including validation studies, before they can be introduced to their markets. New York has the only state licensure program which requir...

Transgenomic and Power3 Medical Complete Agreement for Exclusive License of Neurodegenerative Biomarker Test

...heimer's disease (AD-NuroPro), in the third quarter of 2009 followed by completion of filing with the FDA. Power3 Medical operates a state-of-the-art clia certified laboratory in The Woodlands (Houston), Texas. Power3 Medical continues to evolve and enhance its IP portfolio, employing sensitive and spec...

Cepheid Molecular Diagnostic Test for Positive Blood Culture Bottles Categorized 'Moderate Complexity' by FDA

...or marketing last month, Xpert MRSA/SA BC is the first molecular diagnostic test for positive blood culture bottles to receive the moderate complexity clia categorization. The test runs on Cepheid's GeneXpert(R) System, the leading platform for on-demand detection of Healthcare Acquired Infections (HAIs)....

Johns Hopkins University Researchers to Clinically Assess Rosetta Genomics' miRview(TM) Squamous Assay

... Earlier This Year Rosetta Genomics is Expecting to Launch miRview(TM) Squamous Later This Year Through its Recently Acquired clia lab in Philadelphia REHOVOT, Israel and JERSEY CITY, New Jersey, October 2 /PRNewswire-FirstCall/ -- Rosetta Genomics, Ltd. (NASDQ: ROSG), a leader ...
CLIA in Medical Products

Paradigm II Compliance Software for CLIA compliance

Description: Paradigm II utilizes powerful Document Management and Records Management modules that provide complete flexibility for you to decide how you want to manage your Lab Quality system, while providing transparent accountability to all of your critical processes over the LAN or Intranet . Parad...
Company:Interax Group, Inc.

ADC CLIA WAIVED Cocaine Test Card

Description: The ADC drugs of abuse tests are highly accurate in detecting the presence of drugs at the SAMHSA recommended cut-off as confirmed by GC/MS testing. This assay provides a preliminary test result. A more specific alternative method (such as GC/MS) must be used in order to obtain a confirmed result. ...
Company:Inverness Medical Innovations

ThyroChek

Description:...ay that is easy to use, cost effective and accurate. It is ideal for physician office labs, pharmacy programs and health promotion. ThyroChek is clia waived and may be performed in either waived or moderately complex facilities without special staff training. ThyroChek requires one drop of blood fr...
Company:SD Canada

Flu A/B ASR

Description:...m. * Analytical and performance characteristics are not established. ASRs can only be sold to clinical laboratories regulated under the clia of 1988, as qualified to perform high complexity testing under 42 CFR part 493 or under VHA directive 1106. ** See specific ASR product datashe...
Company:Cepheid

mecA ASR

Description:...m. * Analytical and performance characteristics are not established. ASRs can only be sold to clinical laboratories regulated under the clia of 1988, as qualified to perform high complexity testing under 42 CFR part 493 or under VHA directive 1106. ** See specific ASR product datashe...
Company:Cepheid

Mycoplasma pneumoniae ASR

Description:...m. * Analytical and performance characteristics are not established. ASRs can only be sold to clinical laboratories regulated under the clia of 1988, as qualified to perform high complexity testing under 42 CFR part 493 or under VHA directive 1106. ** See specific ASR product datashe...
Company:Cepheid

RSV ASR

Description:...m. * Analytical and performance characteristics are not established. ASRs can only be sold to clinical laboratories regulated under the clia of 1988, as qualified to perform high complexity testing under 42 CFR part 493 or under VHA directive 1106. ** See specific ASR product datashe...
Company:Cepheid

Staphylococcus aureus (SPA) ASR

Description:...m. * Analytical and performance characteristics are not established. ASRs can only be sold to clinical laboratories regulated under the clia of 1988, as qualified to perform high complexity testing under 42 CFR part 493 or under VHA directive 1106. ** See specific ASR product datashe...
Company:Cepheid

ICON 25 hCG Test

Description:... test will reshape your thinking. It gives you fast, accurate results, plus Beckman Coulter confidence. For the physician's office, ICON 25 hCG offers clia waived simplicity for urine and a "moderately complex" catergorization for serum. For the hospital, it's the perfect complement to our ICON II HCG tes...
Company:Beckman Coulter, Inc

Tag-It Cystic Fibrosis ASPE Mix

Description:... The Tag-It™ Cystic Fibrosis ASR reagents can be used by high complexity clia approved laboratories for detection of up to 70 mutations and 6 variants (polymorphisms) in the cystic fibrosis transmembrane conductance regulator (C...
Company:Tm Bioscience Corporation

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CLIA in Medical Dictionary

Urine drug screen

... in the urine . ... ... American Screening Corp. American Screening Corporation - Drug Testing, Urine ... Alco Screen . 5 Panel Key Cup- clia WAIVED. ORALERT 6 Panel Saliva Drug Test ... The most reliable way to pass a urine drug screen is to use QCarbo Easy Cleanser. ... THC Mar...
CLIA in Biological News

GenWay Biotech obtains exclusive rights to AMDL's DR-70 cancer test in US and Canada

... cancer test in both the United States and Canada. GenWay Biotech will be the exclusive distributor of the DR-70 test for general cancer screening by clia laboratories in the United States and for lung cancer screening in Canada. The commercialization efforts include raising awareness of the disease and...
CLIA in Biological Technology

HemoCue Receives First FDA CLIA Waiver in Diagnostics Industry for Quantitative Point-of-Care Test for Microalbuminuria, a Kidney and Cardiovascular Disease Risk Marker

MADISON, N.J., June 18 /PRNewswire-FirstCall/ -- HemoCue(R) AB, a global point-of-care diagnostic test manufacturer and wholly owned subsidiary of Quest Diagnostics Incorporated (NYSE: DGX ), today announced that its HemoCue Albumin 201 System is the first quantitative point-of-care test for ...

SEQUENOM Reports Second Quarter 2009 Financial Results and Highlights

... near future. Diagnostics Business Commercial Launch Plans - The company is on track to launch three diagnostic products through its clia laboratory by the first quarter of 2010 - cystic fibrosis carrier screen (CFTR), RHD and fetal sex determination. The first of these tests - CFTR - is...

FDA Grants First Authorization of a Commercial 2009 H1N1 Flu Test for use During Pandemic Flu Emergency to Quest Diagnostics' Focus Diagnostics Business

...enza strain circulating in the U.S. this flu season." Quest Diagnostics is currently in the process of validating the test at a number of its clia high complexity laboratories around the U.S. capable of performing the test in compliance with the emergency use authorization. The Quest Diagnostics ...

Bio/Data Corporation Launches vW Select(TM) - The World's First and Only Complete Ristocetin CoFactor Assay

... Quality System Regulations as well as the ISO 13485:2003 (Medical Device) Quality Management System Standard. This simplifies test Implementation and clia compliance, while eliminating the onerous regulatory mandates for homebrew or lab developed tests. The analytical variability of existing Ristoce...

New England Journal of Medicine Study Highlights Need for Rapid, PCR-based Group B Streptococcus (GBS) Testing at Time of Admission for Labor and Delivery

... criteria for rapid intrapartum GBS testing. Xpert GBS is also the only PCR-based antepartum and intrapartum GBS test to receive 'Moderate Complexity' clia categorization by the U.S. Food & Drug Administration (FDA), enabling healthcare professionals such as labor and delivery nurses to run the test n...

Exiqon Diagnostics Partners With MedTrust Online to Promote KRAS Mutation Analysis and Other Innovative Molecular Oncology Diagnostic Services to Oncologists

...iagnostics (the tradename for Oncotech, Inc, a wholly owned subsidiary of Exiqon A/S), is a leader in personalizing medicine for cancer patients. As a clia and CAP-certified laboratory, Exiqon Diagnostics develops and performs novel molecular and cell-based oncology assays to help physicians individualize...

Agendia Supports Genentech's Citizen's Petition Urging FDA to Hold In-Vitro Diagnostic Tests to One Set of Scientific and Regulatory Standards

...ystems that ensure patient safety issues are addressed. Manufacturers of breast cancer recurrence assays that are not FDA-cleared operate solely under clia regulations and are free to make claims of superiority, safety or otherwise, regardless of scientific and clinical evidence. Consequently, physicians ...

Transgenomic and Power3 Medical Introduce NuroPro(R) Tests for Alzheimer's and Parkinson's Diseases at AAN Annual Meeting

...kinson's disease (NuroPro AD and PD), in the fourth quarter of 2009, followed by completion of filing with the FDA. Power3 operates a state-of-the-art clia certified laboratory in The Woodlands (Houston), and continues to evolve and enhance its IP portfolio, employing sensitive and specific combinations o...

SeqWright Expands into the Genetically-Targeted Therapy Field by Partnering with PharmaGenoma to Provide Next-Generation Hair Loss Treatment Genetic Testing

...OUSTON, April 28 /PRNewswire/ -- SeqWright Inc., a clia certified and GLP compliant provider of custom gen...clinical laboratory. This license, along with its clia certification, allows SeqWright to handle clinical...dividual's genetic make up. PharmaGenoma uses only clia certified laboratories (Clinical Laboratory Improv...

California Grants SeqWright License to Operate as a Clinical Laboratory

...order to provide genetic tests to California residents and represents a significant step forward in the shift towards personalized medicine. With its clia certification and a California clinical laboratory license, SeqWright is capable of performing validated genetic tests on individuals throughout the m...
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