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Issues And Trends In Healthcare Delivery System01:29

Issues And Trends In Healthcare Delivery System

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The issues and trends in healthcare delivery are constantly changing. The COVID-19 pandemic is one recent issue that wreaked havoc on healthcare systems, causing a shortage of healthcare workers, high demand for medicines and supplies, and increased medical expenditure due to a lack of insurance. Other issues include rising healthcare costs and care fragmentation.
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Genomics02:02

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Genomics is the science of genomes: it is the study of all the genetic material of an organism. In humans, the genome consists of information carried in 23 pairs of chromosomes in the nucleus, as well as mitochondrial DNA. In genomics, both coding and non-coding DNA is sequenced and analyzed. Genomics allows a better understanding of all living things, their evolution, and their diversity. It has a myriad of uses: for example, to build phylogenetic trees, to improve productivity and...
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Genetic screens are tools used to identify genes and mutations responsible for phenotypes of interest. Genetic screens help identify individuals or a group of people at risk of developing  genetic diseases and help them with early intervention, targeted therapy, and reproductive options.
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Diploid organisms inherit genetic material through chromosomes from both parents. Copies of the same gene are known as alleles. In most cases, both alleles are simultaneously expressed and allow various cellular processes to function optimally. If one of the alleles is missing or mutated, the expression of the other allele can compensate; however, this is not true for all genes.
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Updated: Jan 4, 2026

Targeted Next-generation Sequencing and Bioinformatics Pipeline to Evaluate Genetic Determinants of Constitutional Disease
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Current Policy Challenges in Genomic Medicine.

Roger D Klein1

  • 1Center for Law, Science, and Innovation, Sandra Day O'Connor College of Law, Arizona State University, Tempe, AK.

Clinical Chemistry
|November 9, 2019
PubMed
Summary

Policy challenges in molecular genetic testing, including payment, FDA oversight of lab-developed tests, and gene patenting, impact genomic medicine advancement and patient access. These issues require careful consideration for continued progress.

Area of Science:

  • Genomic Medicine
  • Molecular Diagnostics
  • Health Policy

Background:

  • Molecular genetic testing faces policy hurdles in privacy, reimbursement, and regulation.
  • Recent Medicare changes to test pricing and coverage for next-generation sequencing (NGS) in cancer patients introduce significant restrictions.
  • The US Food and Drug Administration (FDA) and Congress are exploring new regulatory frameworks for laboratory-developed tests (LDTs).

Purpose of the Study:

  • To review current policy issues impacting genetic and genomic testing.
  • To analyze the implications of payment policies, laboratory oversight, and gene patenting.
  • To discuss the potential effects on diagnostic innovation and genomic medicine.

Main Methods:

  • Literature review of policy documents and scientific publications.

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  • Analysis of recent legislative and regulatory developments.
  • Discussion of landmark court cases related to gene patenting.

    • Main Results:

    • Coverage and reimbursement policies pose significant challenges to genetic testing.
    • Potential FDA regulation of LDTs threatens diagnostic innovation and laboratory viability.
    • Reinstatement of gene patents could impede genomic medicine's progress.

    Conclusions:

    • Navigating complex payment and regulatory landscapes is crucial for genetic testing.
    • The future of genomic medicine depends on balancing innovation with oversight.
    • Policy decisions regarding LDTs and gene patents will shape the accessibility and advancement of genetic and genomic testing.