Research & Development
Policy & Regulation
Trends & Finance
Labs and manufacturers face challenges with rollout of IVDR
Laboratories and medical device manufacturers have revealed how they face technical and workload challenges in gearing up to comply with stringent new European Union regulations.
October 2, 2023
USP proposes synthetic alternative to horseshoe crab blood in endotoxin testing
The U.S. Pharmacopoeia (USP) has published draft guidelines on using a synthetic alternative to reagents derived from horseshoe crabs, advancing efforts to provide an alternative way of performing endotoxin testing.
August 31, 2023
NGS working group provides recommendations for germline variant confirmation
A joint report provides eight recommendations for standardizing orthogonal confirmation practices for germline variants detected by next-generation sequencing.
May 19, 2023
NCI study outlines challenges, opportunities in achieving Cancer Moonshot goals
A National Cancer Institute study outlined challenges and opportunities in achieving President Biden’s Cancer Moonshot goal -- a 50% reduction in U.S. cancer death rates by 2047.
April 18, 2023
Report identifies bias factors in clinical genetic testing
ACMG committees worked together on a points-to-consider report in light of the potential for clinical, technical, and environmental biases to influence equitable access to clinical genetics testing.
April 14, 2023
AACC provides recommendations for detecting cervical cancer
The guidance aims to update healthcare and laboratory medicine professionals about the latest advancements in this field, and to help them select the most effective cervical cancer detection strategy for their patients, AACC said.
March 6, 2023
Agendia MammaPrint UltraLow Risk gene signature recognized in updated NCCN guidelines
The MammaPrint 70-gene signature identifies patients at low or high risk of distant recurrence within five years of a breast cancer diagnosis.
February 13, 2023
Study suggests race adjustment unnecessary for alpha fetoprotein prenatal testing
Researchers recommend that a longstanding race-based adjustment to test-result values of alpha fetoprotein from a common prenatal screening should be discontinued.
February 6, 2023
OIG report outlines challenges with CDC-supported COVID-19 vaccination programs
There were challenges with "vaccine logistics, such as large minimum order sizes for vaccines, requirements for ultra-cold storage, and insufficient ancillary supplies," OIG said.
January 31, 2023
Natera announces results for NIPT in twin-pregnancy clinical study
Using single-nucleotide polymorphism technology, the test analyzes fetal DNA obtained through a blood draw from the mother.
December 7, 2022
Stop: Don't order these tests
Industry organizations have collaborated on recommendations to ensure patients receive the right testing at the right time.
November 8, 2022
FDA proposes updates to breakthrough devices guidance focused on reducing disparities in healthcare
The agency is proposing updates to clarify considerations in designating devices, including eligible devices that may benefit populations impacted by disparities in healthcare.
October 20, 2022
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