Justin Saeks and Bruce Carlson

Infectious
Antigen tests drive COVID-19 test market to $10.5B
Even in the fall of 2020, there are capacity limitations, questions about testing accuracy, and challenges with sample collection. But creative solutions have been emerging at labs to help ease the load during a difficult time.
November 9, 2020
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Cancer
Invivoscribe, Complete Genomics partner to develop NGS tests for cancer research, detection
Under the terms of the deal, Invivoscribe will be responsible for the development of biomarker tests, including test controls and associated bioinformatics software. The tests will run on Complete Genomics' NGS platforms.
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Regulatory Approval
Seegene obtains IVDR certification for 30 diagnostic assays
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Policy and Regulation
Advocacy groups in letter urge FDA to develop regulations for lab-developed tests
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Collaboration
Nucleai, Adlai Nortye collaborate on biomarkers for clinical trials
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Invivoscribe, Complete Genomics partner to develop NGS tests for cancer research, detection
Under the terms of the deal, Invivoscribe will be responsible for the development of biomarker tests, including test controls and associated bioinformatics software. The tests will run on Complete Genomics' NGS platforms.
June 2, 2023
Dna Sequencing2 Social
Seegene obtains IVDR certification for 30 diagnostic assays
The newly certified assays include eight for gastrointestinal infections, seven for women's diseases, five for respiratory diseases, four for tuberculosis, three for meningitis, two for human papillomavirus (HPV), and one for drug resistance.
June 1, 2023
Test Tube Liquid Sample Social
Advocacy groups in letter urge FDA to develop regulations for lab-developed tests
The FDA should use its authority to develop laboratory-developed test regulations if Congress does not pass legislation requiring it, said the Center for Science in the Public Interest and other organizations.
June 1, 2023
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Nucleai, Adlai Nortye collaborate on biomarkers for clinical trials
The partnership will combine Nucleai's expertise in extracting and analyzing the quantitative spatial features of pathology images and Adlai Nortye's expertise in drug development and immunotherapy.
May 31, 2023
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Long COVID symptoms reported by 17% of unvaccinated people
One in six unvaccinated people report persistent health impacts from COVID-19 two years after a confirmed SARS-CoV-2 infection.
June 1, 2023
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One-third of U.S. adults with diabetes may have undetected cardiovascular disease
Researchers at Johns Hopkins University have generated evidence of how prevalent elevated levels of two biomarkers are in U.S. adults, with and without diabetes.
June 1, 2023
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Serum assay may enable the diagnosis of neurodegenerative diseases
An assay that detects minute concentrations of alpha synuclein seeds in blood serum may enable quicker diagnosis of neurodegenerative disorders.
May 30, 2023
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Asep Medical Holdings aims for Nasdaq listing
Sepset Biosciences, an Asep Medical business, is preparing for clinical studies aimed at the commercialization of a diagnostic test. The test leverages gene expression to predict the development of severe sepsis.
May 31, 2023
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Georgia doctor, clinics to pay $625K to resolve False Claims Act allegations
The defendants allegedly submitted improper claims to Medicare and Tricare insurance programs for evaluation and management services as well as medically unnecessary urine drug screening tests.
May 31, 2023
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Single-cell RNA sequencing data reveals T cells linked to cancer immunotherapy resistance
Scientists at the University of Texas MD Anderson Cancer Center have provided a new explanation for why checkpoint inhibitors are ineffective in some patients.
May 30, 2023
T Cell Social
Bacteria vary between early- and late-onset colorectal cancer tumors: Study
Bacteria types vary widely between early- versus late-onset colorectal cancer tumors, providing clues to the disease’s increase in younger people, according to a study.
May 30, 2023
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At ASCO meeting, Veracyte highlights prostate cancer study data using genomics database
The Decipher GRID database, which is used by Veracyte and its partners in urologic cancer research, comprises more than 100,000 whole-transcriptome profiles from patients with urologic cancers.
May 30, 2023
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