News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups
Hosted by Robert Michel

News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups
Hosted by Robert Michel
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Best Practices in Molecular Assay Validation for Laboratory-Developed Tests

Best Practices in Molecular Assay Validation for Laboratory-Developed Tests

Feb 15, 2024 | White Papers

Seegene White Paper on Dark Daily website

Dark Daily’s free white paper, “Best Practices in Molecular Assay Validation for Laborator-Developed Tests,” is for the laboratory community and has been produced in partnership with Seegene USA. It is available for free download.

Molecular laboratory developed tests (LDTs) play a crucial role in providing accurate and timely patient care. These methods are designed to address those analytes or disease markers for which there is no commercially available test, so ensuring the safety and accuracy of these LDTs is not just an option – it’s a necessity.


This comprehensive white paper is designed to be your go-to guide, providing invaluable insights into critical success factors and essential functions crucial for maintaining compliance and delivering reliable results. Tailored for clinical molecular laboratory staff, this resource delves into the tangible aspects of compliant method validation, offering practical strategies for proving the accuracy and efficacy of laboratory-developed tests (LDTs).

Click here to download the free white paper. For additional information inquire at info@darkreport.com, or call Amanda Curtis at 512-264-7103.

Published February 15, 2024
Produced in partnership with

Seegene USA
Point of Care Testing for Infectious Diseases: Navigating CLIA Compliance and Ensuring Quality

Point of Care Testing for Infectious Diseases: Navigating CLIA Compliance and Ensuring Quality

Dec 19, 2023 | White Papers

Dark Daily White Paper HIV Drug Resistance Testing

Dark Daily’s free white paper, “Point of Care Testing for Infectious Diseases: Navigating CLIA Compliance and Ensuring Quality,”  is for the health laboratory community and has been produced in partnership with LGC Clinical Diagnostics. It is available for free download.

When it comes to point-of-care (POC) testing for infectious diseases, a meticulously crafted quality system is not just an option—it’s a necessity. Ensuring safety and satisfaction hinges on having the right practices in place.

This comprehensive white paper is designed to be your go-to guide, providing invaluable insights into critical success factors and essential functions crucial for maintaining compliance and delivering reliable results. Tailored for POC teams outside the clinical laboratory, this resource delves into the tangible aspects of good laboratory practice and regulatory compliance, offering practical knowledge applicable to both routine and urgent patient care settings.

Click here to download the free white paper. For additional information inquire at info@darkreport.com, or call Amanda Curtis at 512-264-7103.

Published November 20, 2023
Produced in partnership with

LGC Clinical Diagnostics Logo
Virus Surveillance: Empowering Communities Through Early Genotypic Testing for HIV Drug Resistance

Virus Surveillance: Empowering Communities Through Early Genotypic Testing for HIV Drug Resistance

Mar 28, 2023 | White Papers

Dark Daily White Paper HIV Drug Resistance Testing

Dark Daily’s free white paper, “Virus Surveillance: Empowering Communities Through Early Genotypic Testing for HIV Drug Resistance,” addresses several facets of HIV surveillance, including genotypic testing for drug-resistant mutations, virus cluster detection and response, and programs in action. The new white paper for the health laboratory community has been produced in partnership with Thermo Fisher Scientific and is available for free download.

As antiretroviral drugs are a primary HIV therapy, the World Health Organization (WHO) warns that all antiretrovirals, including those from newer drug classes, are at risk of becoming partially or fully inactive due to the emergence of drug-resistant virus—it’s just a matter of time. This is an important point because if not prevented, HIV drug resistance can jeopardize the efficacy of medicines used to treat HIV, resulting in increased numbers of HIV infections, HIV-associated morbidity and mortality, and the need to develop new antiretrovirals.

Health laboratory directors interested in reducing the impact of emerging and harmful HIV drug-resistant mutations can use this white paper educational supplement for a new look at:

  • Care gaps in viral load monitoring and drug resistance testing;
  • Recent developments signaling new paths forward with HIV-1 testing; and
  • Programs that monitor genetic evolution of drug-resistant mutations for people living with HIV.

This report specifically addresses drug-resistance testing needs, policy decisions influencing HIV testing, and insights from virus surveillance, cluster detection and response efforts. The white paper also includes a reference resource list.

Click here to download the free white paper. For additional information inquire at info@darkreport.com, or call Amanda Curtis at 512-264-7103.

Published March 27, 2023
Produced in partnership with

Dark Daily White Paper HIV Drug Resistance Testing
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