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CLIA: Page 4
Applied Biology to enter CLIA lab market in Calif.
By
LabPulse.com staff writers
The company applied for CLIA accreditation with the California Department of Public Health, and it has appointed Dr. Daniel YK Chan as the laboratory director.
February 12, 2020
Lexent Bio partners on NGS with Illumina
By
LabPulse.com staff writers
Confera Dx is designed to monitor treatment response and the level of minimal residual disease (MRD) in cancer patients. The company plans to launch the product as a laboratory-developed test (LDT) with testing done at its own CLIA lab, and Lexent will also pursue clearance by the U.S. Food and Drug Administration (FDA) to enable use in the local labs of hospitals and health systems.
November 7, 2019
Veracyte nasal swab test holds its own in lung cancer detection
By
Emily Hayes
The South San Francisco, CA-based company is developing the nasal product as a laboratory-developed test for its own CLIA-certified facility and plans to introduce it commercially in early 2021, following additional analytical work and studies, according to Giulia Kennedy, PhD, chief scientific and medical officer. Development is ongoing as part of a broader partnership with Johnson & Johnson related to the early detection of lung cancer.
October 21, 2019
New AncestryHealth features physician-ordered tests in CLIA labs
By
LabPulse.com staff writers
The company's new AncestryHealth tests will complement its long-running AncestryDNA genealogy services. Health testing will be ordered by physicians and performed by independent CLIA-certified laboratories, the company noted in a statement. To complement testing, Ancestry will provide genetic counseling and other educational resources, along with reports that suggest how to act on the findings in consultation with health professionals. The new offerings may be accessed on a one-time basis or as part of a regular subscription service.
October 14, 2019
Genomic tests for melanoma in the spotlight
By
LabPulse.com staff writers
The article contains recommendations from a consensus panel of dermatologists and dermatopathologists on three reverse transcription quantitative polymerase chain reaction (RT-qPCR) tests for gene profiling that are CLIA-waived and cleared by the U.S. Food and Drug Administration (FDA):
September 17, 2019
AACC: How not to fail your lab inspection
By
Emily Hayes
More than 8,000 labs are accredited on a voluntary basis by the Northfield, IL-based College of American Pathologists (CAP) and must meet particular requirements for proficiency testing. In June, the organization published a list of 41 labs that had been continuously accredited since 1964. CAP may provide inspections instead of the U.S. Centers for Medicare and Medicaid Services (CMS), which has an oversight role for labs through CLIA.
August 7, 2019
PerkinElmer, FDNA team up on AI-enhanced genetic testing
By
LabPulse.com staff writers
The plan is to marry NGP, which enables the collection and rapid analysis of phenotypic and genotypic data -- including facial analysis -- for use in genomic profiling, with PerkinElmer's testing and laboratory services. PerkinElmer Genomics has two CLIA labs in the U.S., with services including newborn screening and biochemical profiling, as well as integrated labs in India, Malaysia, and China. The lab network focuses heavily on newborn screening and the detection of rare genetic diseases.
June 24, 2019
CAP showcases labs accredited for over 50 years
By
LabPulse.com staff writers
CAP noted that the program helps labs comply with regulations from the U.S. Centers for Medicare and Medicaid Services (CMS), which has an oversight role through the Clinical Laboratory Improvement Amendments (CLIA) of 1988. Accreditation includes onsite checks by laboratory peer inspectors every two years and compliance with quality and procedural checklists that are regularly updated. Through CAP accreditation, labs may also show that they are keeping up to date with new technologies in the pathology field, such as information technology, artificial intelligence, and liquid biopsies.
June 23, 2019
New world order for STD tests | Red flags on CLIA-waived products | FDA's burst of preholiday actions
By
Emily Hayes
Dear LabPulse Member,
May 27, 2019
Growth in number, complexity of CLIA-waived test kits raise red flags
By
Joseph Constance
Test kits that are waived from CLIA oversight are considered to be straightforward enough that they may be performed easily. But sometimes procedural mistakes occur when untrained clinical lab personnel work without the benefit of external quality assurance testing, and errors may not get picked up until the damage has been done.
May 21, 2019
CMS hikes user fees for CLIA labs by 20%
By
Brian Casey
Based on an analysis of financial data, the agency will require an increase in user fees to regulate CLIA labs under the requirements of the Clinical Laboratory Improvement Amendments (CLIA) of 1998. That statue requires CMS to assess user fees to cover its administration of the CLIA program.
January 2, 2019
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