Brian Casey

Moderate Complexity Test
HHS: FDA review not needed for coronavirus LDTs
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
Infectious
AACC says December meeting will be all-virtual
In an email to members, AACC said the group's board of directors had made a "pivotal decision" to hold the annual meeting entirely as a virtual event. AACC 2020 will continue to be held December 13-17, the same dates as the in-person meeting.
August 18, 2020
2020 08 19 21 08 7377 Business Virtual Meeting Laptop 400
Lawsuit
Feds arrest president of blood testing firm on fraud charges
Mark Schena was arrested on charges that he and Arrayit allegedly misled investors, manipulated the company's stock price, and conspired to commit healthcare fraud by submitting over $69 million in fraudulent claims for allergy and COVID-19 tests. The arrest was announced in a June 9 press statement by the U.S. Attorney's Office for the Northern District of California.
June 9, 2020
2019 05 15 19 42 9457 Gavel3 400
PCR
What are the risks of false-negative COVID-19 tests?
In the article, the authors maintain that the sensitivity and other aspects of reverse transcription polymerase chain reaction (RT-PCR) testing for COVID-19 have not been clearly reported. RT-PCR testing is most useful when tests are positive, but it's less useful for ruling out infection with SARS-CoV-2, the virus that causes COVID-19. Therefore, a negative RT-PCR test does not mean a person is free of the disease, noted Dr. Priya Sampathkumar of the Mayo Clinic in Rochester, MN, in a release.
April 12, 2020
2019 07 26 20 46 7792 Lab Blood Woman 400
Health Topics
Testing delays hamper hospitals in COVID-19 response
Hospitals say that delays of up to a week in getting COVID-19 diagnostic test results are creating a crunch in intensive care units (ICUs) as patients must remain hospitalized until their results come back. And supplies for COVID-19 diagnostic kits are in such short supply that some facilities are dividing media in half to double their testing capacity.
April 9, 2020
2020 04 09 21 26 3552 Hospital Corridor Gurney 400
Health Topics
Did BodySphere jump the gun on '2-minute' COVID-19 test?
And in the end, it apparently was false. News reports have questioned the company's claims, and BodySphere's chairman and CEO has walked back the company's assertion that it had received the FDA's imprimatur. But the firm said it still intends to sell the test on the market.
April 2, 2020
2020 01 27 21 38 4451 Lab 2019 Coronavirus Test 400
Moderate Complexity Test
FDA gives states, vendors more power in coronavirus fight
The FDA has been under heavy pressure to ease its regulations on diagnostics to get more tests into the field for the SARS-CoV-2 coronavirus, which causes the COVID-19 respiratory disease. Clinicians and public health authorities have claimed that not enough tests are available to meet demand, so the agency has made a series of regulatory changes over the last several weeks that relax its oversight.
March 15, 2020
2019 02 13 19 24 5396 Fda Logo V2 400
PCR
FDA grants EUA to Thermo's coronavirus diagnostic test
The FDA granted the EUA to Thermo Fisher's TaqPath COVID-19 combo kit, a multiplex real-time reverse transcription polymerase chain reaction (RT-PCR) diagnostic test that can diagnose the SARS-CoV-2 virus, which causes COVID-19.
March 15, 2020
2020 01 27 21 38 4451 Lab 2019 Coronavirus Test 400
Infectious
TEST -- ignore
March 14, 2020
Moderate Complexity Test
Trump emergency plan boosts diagnostic testing rollout
In an address at the White House Rose Garden, Trump announced a series of sweeping measures designed to eliminate government regulations that may have been hindering the federal response to the coronavirus outbreak. Most of Trump's address was devoted to the administration's plans for making diagnostic testing more available across the country -- an issue that has become a flash point for criticism of the administration's response to the virus.
March 12, 2020
2020 03 13 20 59 0533 White House 400
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HIV vaccine trial begins enrollment in U.S., South Africa
A clinical trial for a preventive HIV vaccine has begun enrollment in both the U.S. and South Africa.
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Alzheimer’s drug approval poised to reshape APOE testing market
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AI model reveals kidney tumor features, potential for treatment response prediction
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NIH awarding $50.3M to establish multiomics consortium
The U.S. National Institutes of Health (NIH) announced that it will award $50.3 million over five years to establish a multiomics research consortium.
September 14, 2023
Research Money Social
Whistleblower claims CIA analysts were bribed to reject COVID-19 'lab leak' origin hypothesis
A whistleblower gave testimony to two panels of the House of Representatives alleging that six CIA analysts were bribed to reject the theory that the COVID-19 pandemic resulted from a research-related leak of a new coronavirus.
September 15, 2023
Infectious Diseases Research Social
Castle Biosciences Pittsburgh lab receives N.Y. state permit
Castle Biosciences has received a clinical laboratory permit from the New York State Department of Health for its Pittsburgh laboratory.
September 13, 2023
Lab Scientist Biosafety Social
Researchers link changes in lipids to human health, disease, and aging
Researchers have tracked changes to lipids during respiratory viral infection, insulin resistance, and aging, suggesting that the fats may play a role in immune homoeostasis and inflammation regulation.
September 13, 2023
Molecule Social
Autologous cell therapy improves outcomes in COPD patients in small trial
Treating chronic obstructive pulmonary disease (COPD) patients with their own cells improved outcomes in an early-phase clinical trial, encouraging the researchers to plan a larger study.
September 14, 2023
Lungs 3 D Research Social
Agilent to sell Resolution Bioscience to Exact Sciences
Agilent Technologies has announced that it is selling Resolution Bioscience, its cancer testing business, to Exact Sciences for an undisclosed sum.
September 12, 2023
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Identification of hundreds of blood pressure genes lays foundation for hypertension drugs
Researchers have found hundreds of genes that may affect blood pressure, setting the stage for further studies that could inform the development of new treatments for hypertension.
September 12, 2023
Cell Gene Therapy Dna Social
Navigate BioPharma, Becton Dickinson collaborate on CDx solutions
Navigate BioPharma and Becton Dickinson have formed a strategic collaboration to use flow cytometry to develop and commercialize companion diagnostics (CDx) and clinical decision-making solutions.
September 11, 2023
Lab Scientists Social
Study: Blood clotting proteins may contribute to COVID-19 'brain fog,' cognitive problems
The presence of blood clots may help explain cognitive problems such as "brain fog" in patients following COVID-19 infection, say researchers.
September 13, 2023
Covid Brain Visual Social
Researchers create low-cost, eco-friendly COVID-19 test
Scientists say they have engineered an accurate, low-cost, and eco-friendly COVID-19 test that could dramatically reduce environmental waste.
September 12, 2023
Nasal Swab Test Social
Ibex Medical Analytics launches AI-powered breast cancer biomarker scoring platform
Ibex Medical Analytics has launched a breast cancer biomarker scoring tool powered by artificial intelligence (AI) to help clinicians with treatment decisions.
September 11, 2023
Breast Specialist Ultrasound Exam Social
Researchers develop at-home device for diagnosing gingivitis
Researchers at the University of Cincinnati in Ohio are developing a device people can use at home to diagnose gingivitis.
September 12, 2023
Inflamed Gums Man Social
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