Diagnostics


  • A person wearing goggles and holding a clipboard looks at a tray in a laboratory.
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    Courtesy of Exact Sciences
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    Exact Sciences wins FDA approval for Cologuard Plus colorectal cancer test

    Exact Sciences expects to launch the updated test, which has higher specificity than its predecessor, with Medicare coverage and guideline inclusion in 2025.

    By Oct. 7, 2024
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    Stringer via Getty Images
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    GE Healthcare gets FDA nod for new PET imaging agent

    Called Flyrcado, the radiotracer could help improve cardiac imaging accuracy in patients with a high body mass index and women, the company said.

    By Oct. 1, 2024
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    Sitthiphong via Getty Images
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    Trendline

    Medical device industry continues to turn to AI

    While the industry continues to embrace artificial intelligence, there are still questions about how the new technologies need to be regulated and if they are effective.

    By MedTech Dive staff
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    halbergman via Getty Images
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    Top medtech conferences in 2025

    The lineup includes industry wide conferences and events covering the latest medtech trends in diabetes, orthopedics, cardiac care and surgical robotics.

    By Oct. 1, 2024
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    Tom Brenner via Getty Images
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    Congress again delays steep cuts in Medicare lab payments

    The American Clinical Laboratory Association welcomed the reprieve but said long-term reform of the Medicare payment system is still needed.

    By Sept. 26, 2024
  • A sign for the FDA is displayed outside the agency's headquarters in Silver Spring, Maryland.
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    Sarah Silbiger via Getty Images
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    FDA proposes reclassifying hepatitis B assays

    The FDA plans to move the assays from higher-risk class III devices to class II, making them eligible for the 510(k) pathway.

    By Sept. 26, 2024
  • A Roche logo is seen on the side of a building.
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    Courtesy of Roche
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    Roche launches test that detects 12 respiratory viruses

    Roche’s TAGS technology allows tests to simultaneously detect multiple respiratory viruses, including influenza A and B, RSV and the COVID-19 virus.

    By Sept. 25, 2024
  • A physician looks at computer screens that show brain imaging.
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    Courtesy of GE Healthcare
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    GE Healthcare wins FDA clearance for Alzheimer’s imaging software

    The clearance adds a Centiloid scale tool to GE Healthcare’s Mim software to help clinicians determine the density of amyloid plaque.

    By Sept. 20, 2024
  • Anne Wojcicki sits in a chair speaking with Marcus Wallenberg during an event.
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    Kimberly White/Getty Images via Getty Images
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    23andMe’s independent board directors resign

    In a letter to CEO Anne Wojcicki, the directors said they’d resign “rather than have a protracted and distracting difference of view with you” about the company’s future.

    By Sept. 19, 2024
  • Senior Research Associate Tanya Quint loads one of the instruments used to run Exact Sciences' Cologuard test at the company's headquarters in Madison, Wis. (Photo: Business Wire)
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    Courtesy of Business Wire/Exact Sciences
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    Exact Sciences says data support its colon cancer blood test

    Exact’s test could compete with Guardant Health’s Shield blood test, which received approval from the Food and Drug Administration in July.

    By Sept. 16, 2024
  • An image of Inflammatix's TriVerity Acute Infection and Sepsis Test.
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    Courtesy of Inflammatix
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    Inflammatix raises $57M to advance test for infection, sepsis

    Inflammatix has now raised over $200 million in private capital, in addition to more than $50 million in grants and contracts.

    By Sept. 13, 2024
  • An image of Spectrawave's Hypervue intravascular imaging system.
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    Courtesy of Spectrawave
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    J&J leads $50M financing for imaging company Spectrawave

    The Series B round will support commercial expansion and product additions for Spectrawave’s system used in the treatment of coronary artery disease.

    By Sept. 11, 2024
  • Two people in white coats work at a laboratory bench.
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    Adene Sanchez via Getty Images
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    Lab group urges lawmakers to rescind FDA final rule on LDTs

    A survey found 48% of labs will discontinue LDTs if they do not qualify for an exception under the FDA final rule.

    By Sept. 9, 2024
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    Samuel Corum via Getty Images
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    Illumina court ruling limits EU regulators’ merger review power

    The European Commission lacked oversight authority to examine the proposed sale of a cancer-detection company to biotech company Illumina, the court found.

    By Justin Bachman • Sept. 9, 2024
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    iStock via Getty Images
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    Diagnostic errors are common. Here are 4 ways to prevent them.

    A new, more holistic approach to testing is needed to avoid mistakes that can cause harm, said Marcus Schabacker, CEO of the patient safety group ECRI.

    By Updated Sept. 11, 2024
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    Courtesy of Grail
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    Illumina avoids fine for Grail purchase in European court victory

    Illumina will avoid a penalty of 432 million euros after a court ruled the European Commission did not have jurisdiction to challenge the company’s Grail acquisition.

    By Sept. 3, 2024
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    andresr via Getty Images
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    Pathology group sues to block FDA lab test rule

    The Association for Molecular Pathology is the second lab trade group urging the courts to void an FDA policy expanding oversight of diagnostic tests.

    By Aug. 30, 2024
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    Courtesy of Qiagen
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    Qiagen, AstraZeneca expand companion diagnostic pact beyond cancer

    The goal is to enable specialty care providers to perform genotyping while patients are undergoing routine clinical examination.

    By Aug. 29, 2024
  • The entrance to Illumina's San Diego campus.
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    Courtesy of Illumina
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    Illumina wins FDA approval for companion diagnostic cancer test

    Physicians can use the test to identify people eligible for treatment with Bayer’s Vitrakvi and Eli Lilly’s Retevmo, which target cancers that have specific genetic features.

    By Aug. 28, 2024
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    Sarah Silbiger via Getty Images
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    FDA seeks feedback on predetermined change control plans

    The guidance describes changes companies can make to medical devices without filing a new 510(k) or premarket approval supplement.

    By Aug. 26, 2024
  • A Roche logo is seen on the side of a building.
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    Courtesy of Roche
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    Roche to increase global laboratory capacity for mpox testing

    The World Health Organization has declared an mpox outbreak to be a public health emergency of international concern.

    By Aug. 26, 2024
  • Quest Diagnostics building
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    Courtesy of Quest Diagnostics
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    Quest inks deal for University Hospitals’ outreach lab services

    The deal continues Quest’s expansion in Ohio and extends a string of acquisitions that began in May.

    By Aug. 23, 2024
  • A picture of NowDiagnostics' syphilis blood test against a gray background.
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    Courtesy of NowDiagnostics
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    FDA OKs first at-home syphilis test

    NowDiagnostics’ over-the-counter test can return results in 15 minutes with a single drop of blood.

    By Aug. 19, 2024
  • Transmission electron micrograph of SARS-CoV-2 virus particles, isolated from a patient.
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    National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.
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    Routine lab tests fail to detect long COVID in 10,000-person study

    Even people with highly symptomatic long COVID may have “no clinically observable objective findings on routine laboratory testing,” according to a study published by the Annals of Internal Medicine.

    By Aug. 16, 2024
  • A Grail employee in a white coat works in a lab.
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    Courtesy of Grail
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    Grail to shed 350 workers in restructuring

    Less than two months after splitting from Illumina, the liquid biopsy maker is refocusing resources as it pursues an FDA submission for the Galleri multi-cancer early detection test.

    By Aug. 14, 2024
  • A person fills multiple pipettes at once in a laboratory.
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    Permission granted by C2N Diagnostics
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    Unilabs inks deal to sell C2N Alzheimer’s blood tests in Europe

    C2N Diagnostics announced the partnership after recently receiving an investment from the Japanese drugmaker Eisai, which developed the Alzheimer’s drug Leqembi with Biogen.

    By Aug. 12, 2024