Guideline: Page 5

CAP seeks comments on IHC testing guidelines
By LabPulse.com staff writers
The updated guidelines, titled "Principles of Analytic Validation of Immunohistochemical (IHC) Assays," were drafted by an expert panel of pathologists, histotechnologists, and a methodologist. The updates primarily reflect CAP's recent decision to adopt the global evaluation method Grading of Recommendations Assessment, Development and Evaluation (GRADE).
August 4, 2021
2019 08 02 23 46 0673 Lab Vacutainer Test Tube 400
Natera nabs ADLT status
By LabPulse.com staff writers
The test can monitor treatment and is able to detect cancer recurrence up to two years before conventional imaging, according to the firm.
June 20, 2021
2019 09 16 18 27 8672 Quality Check Mark 400
USPSTF releases final research plan on TB screening
By LabPulse.com staff writers
The draft research plan was posted for public comment from March 11 to April 7, 2021. The task force reviewed all submitted comments before finalizing the research plan. The next step is development of a draft recommendation statement.
June 16, 2021
2019 12 03 00 00 5470 Tuberculosis Lungs 400
Patients approve of medical screening at dental offices
By Emily Hayes
In the survey of 573 people, 89% were willing to have their dentist take their blood pressure and 82.9% were willing to undergo lab investigations for medical conditions, researchers from Saudi Arabia reported in a paper published February 2 in the open-access journal Dovepress.
February 4, 2021
2018 10 11 20 26 7990 Patient Woman Doctor 400
CMS rejects Epi proColon payments, sets standards for cancer blood tests
By Emily Hayes
The Epi proColon product screens for the presence in the blood of methylated septin 9 (mSEPT9) DNA; it is the only blood test cleared by the U.S. Food and Drug Administration (FDA) for colon cancer screening.
January 20, 2021
2019 10 01 18 58 9423 Colon2 400
HHS outsources review of some lab-developed COVID-19 tests
By LabPulse.com staff writers
NDA Partners will conduct technical and regulatory reviews of applications for emergency use authorization (EUA) submitted for LDTs, the company said. The company will review EUAs submitted for the COVID-19 lab-developed tests, including tests that combine detection of the novel coronavirus and other respiratory pathogens, according to the contract awarded by the HHS Office of the Assistant Secretary for Health (OASH).
January 20, 2021
2019 10 24 21 35 9053 Lab Scientist 400
ADA lowers optimal blood sugar levels for kids
By LabPulse.com staff writers
The recommendation was published in Diabetes Care in a review article by Dr. Maria J. Redondo, a pediatric endocrinologist at Texas Children's Hospital and professor at Baylor College of Medicine, as well as Dr. Sarah Lyons, pediatric endocrinologist at Texas Children's and assistant professor at Baylor College of Medicine.
January 14, 2021
2021 01 15 21 20 2148 Kid Open Mouth 400
Datar highlights liquid biopsy study results
By LabPulse.com staff writers
The company-sponsored international study included blood samples from more than 30,000 individuals, including thousands of people with 27 types of solid organ cancers. The authors published the results on September 30 in the American Cancer Society's journal Cancer Cytopathology.
November 8, 2020
2019 04 22 18 53 8505 Lab Blood Liquid Samples 400
Exact to acquire early cancer detection firm for $2B
By LabPulse.com staff writers
Thrive has developed CancerSeek, a blood-based cancer detection test that utilizes mutation and protein biomarkers. An early-stage version of the liquid biopsy detected 10 different types of cancer, including seven with no recommended screening guidelines, Exact noted.
October 27, 2020
2020 05 15 23 50 8470 2020 05 14 Bloodtest 400
Holy Grail: Ilumina nabs cancer testing firm in $8B deal
By LabPulse.com staff writers
Grail's premier diagnostic, the Galleri, was able to identify more than 50 types of cancer, including 45 types that have no recommended screening in the U.S., according to the company.
September 20, 2020
2019 04 27 00 03 6781 Dna Sequence Shadow 400
Natera wins Medicare coverage for colorectal cancer test
By LabPulse.com staff writers
The LCD will be effective beginning on October 18, 2020, and applies to Medicare beneficiaries with current or prior stage II or stage III colorectal cancer. The future-effective coverage is consistent with Medicare's draft released in August 2019, the company noted.
September 2, 2020
2019 11 04 19 56 0311 Colorectal Cancer 400
HHS: FDA review not needed for coronavirus LDTs
By Brian Casey
In the guidance, the HHS said that the FDA will not require labs to go through premarket review of LDTs for COVID-19 before they can be used on patients. Labs can choose to seek emergency use authorization (EUA) from the FDA if they wish, and the agency will adjudicate these submissions.
August 19, 2020
2020 01 27 21 38 4451 Lab 2019 Coronavirus Test 400
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