Diagnostics: Page 3
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Deep Dive
5 steps to navigate the FDA’s new lab developed test rule
Laboratories face a series of upcoming deadlines to comply with stricter FDA oversight of in-house tests. Here are five strategies labs can take to be ready.
By Susan Kelly • Oct. 21, 2024 -
Sarah Silbiger via Getty Images
FDA prioritizes guidance on lab developed tests in 2025 plan
The Center for Devices and Radiological Health intends to develop final guidance on its enforcement discretion policy regarding special controls for LDTs, among other topics.
By Nick Paul Taylor • Oct. 18, 2024 -
Alxpin via Getty Images
Medtech Europe calls for urgent reform of MDR and IVDR
The trade group’s intervention follows news that the new commissioner for Health and Animal Welfare will assess the need for legislative changes.
By Nick Paul Taylor • Oct. 18, 2024 -
Courtesy of Metro Toronto Convention Centre
The Medtech Conference4 trends to watch at Advamed’s The Medtech Conference
As medtech companies, experts and regulators gather in Toronto, FDA leadership changes and the upcoming U.S. presidential election loom over the industry.
By Elise Reuter • Oct. 14, 2024 -
Courtesy of Exact Sciences
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 Nick Paul Taylor • Oct. 7, 2024 -
Stringer via Getty Images
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 Susan Kelly • Oct. 1, 2024 -
halbergman via Getty Images
Top medtech conferences in 2025
Some of the industry’s biggest events will take place in the second half of the year, including AdvaMed’s Medtech Conference, HLTH 2025 and TCT’s annual meeting.
By Ricky Zipp • Updated 11 hours ago -
Tom Brenner via Getty Images
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 Susan Kelly • Sept. 26, 2024 -
Sarah Silbiger via Getty Images
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 Nick Paul Taylor • Sept. 26, 2024 -
Courtesy of Roche
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 Nick Paul Taylor • Sept. 25, 2024 -
Courtesy of GE Healthcare
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 Nick Paul Taylor • Sept. 20, 2024 -
Kimberly White/Getty Images via Getty Images
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 Ricky Zipp • Sept. 19, 2024 -
Courtesy of Business Wire/Exact Sciences
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 Susan Kelly • Sept. 16, 2024 -
Courtesy of Inflammatix
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 Susan Kelly • Sept. 13, 2024 -
Courtesy of Spectrawave
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 Susan Kelly • Sept. 11, 2024 -
Adene Sanchez via Getty Images
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 Nick Paul Taylor • Sept. 9, 2024 -
Samuel Corum via Getty Images
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 -
iStock via Getty Images
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 Susan Kelly • Updated Sept. 11, 2024 -
Courtesy of Grail
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 Susan Kelly • Sept. 3, 2024 -
andresr via Getty Images
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 Susan Kelly • Aug. 30, 2024 -
Courtesy of Qiagen
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 Nick Paul Taylor • Aug. 29, 2024 -
Courtesy of Illumina
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 Nick Paul Taylor • Aug. 28, 2024 -
Sarah Silbiger via Getty Images
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 Nick Paul Taylor • Aug. 26, 2024 -
Courtesy of Roche
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 Nick Paul Taylor • Aug. 26, 2024 -
Courtesy of Quest Diagnostics
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 Nick Paul Taylor • Aug. 23, 2024
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