Diagnostics
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Bio-Techne gains breakthrough status for liquid biopsy prostate test
The test analyzes a patient's exosomes to help doctors determine whether a prostate biopsy is needed in patients with an ambiguous PSA test result.
By Susan Kelly • June 18, 2019 -
Lloyd's exits notified body services, leaving UK with 3
The withdrawal comes as Europe faces major concerns about capacity ahead of the new MDR and IVD regs.
By Nick Paul Taylor • June 14, 2019 -
FDA issues draft advice on biotin interference with diagnostic testing
A 2017 agency safety communication reported a patient dying after high levels of biotin interference resulted in falsely low troponin results. Troponin tests are often used to detect heart attacks.
By David Lim • June 13, 2019 -
AMA adopts measures to shape development, uptake of AI systems in healthcare
The policies seek to ensure developers of AI, not physicians, are liable for medical errors involving the technologies.
By Nick Paul Taylor • June 13, 2019 -
OIG estimates Medicare overpaid $269M for sleep studies
OIG thinks the problems occurred because CMS failed to provide the oversight needed to stop payments for noncompliant claims.
By Nick Paul Taylor • June 13, 2019 -
Antibiotic resistance test for gonorrhea gets FDA breakthrough nod
Australia's SpeeDx received the expedited review for a molecular test that detects both N. gonorrhea and a patient's susceptibility or resistance to the antibiotic ciprofloxacin.
By Susan Kelly • June 12, 2019 -
Germany, Ireland push EU to assess device regs preparedness
The delegations think a significant reduction in notified bodies is likely but hope to avoid delaying implementation "unless absolutely necessary."
By Nick Paul Taylor • June 12, 2019 -
Pathology group sets expectations for DTC genetic tests
Amid a growing market for direct-to-consumer genetic tests, the Association for Molecular Pathology urged additional standards for test providers to meet.
By Susan Kelly • June 11, 2019 -
Roche Diagnostics names Schinecker as new CEO
The appointment concludes a transitionary period for the company's diagnostic unit following the August exit of former CEO Roland Diggelmann, who served in the position for 10 years.
By David Lim • June 11, 2019 -
Quest, LabCorp breach stirs questions of cybersecurity risk from outside vendors
The breach could result in new regulations and rules governing how U.S. companies select and assess their vendors, according to Moody's.
By Rebecca Pifer • UPDATED: June 11, 2019 at 10:49 a.m. -
Harvard's Wyss Institute receives $131M gift
The contribution comes from founder Hansjörg Wyss, the former CEO of Swiss device maker Synthes, whose vision for the institute has led to several medical breakthroughs over the past decade.
By Susan Kelly • June 10, 2019 -
Concussion test gets breakthrough nod in fast-growing field
Brain Box's test diagnoses and rates the severity of traumatic brain injury, the incidence of which is on the rise.
By Susan Kelly • June 07, 2019 -
Executives expect AI to transform healthcare within 3 years
Almost 90% of industry leaders are trying AI and other emerging technologies, and high percentages also believe health IT can help them identify unmet consumer needs, according to a report from Accenture.
By Nick Paul Taylor • June 06, 2019 -
LabCorp says 7.7M patients exposed in same data breach as Quest Diagnostics
The company Wednesday also announced Adam Schechter, current lead independent director of LabCorp's board and longtime Merck executive, will replace David King as CEO Nov. 1.
By David Lim • June 05, 2019 -
House committee passes 6% increase in FDA funding
The committee wants one FDA priority, the Transform Medical Device Safety, Cybersecurity, Review, and Innovation initiative, to make do with the same level of funding as it received in fiscal 2019.
By Nick Paul Taylor • June 05, 2019 -
Beckman Coulter buys Cytobank to add data analysis software
The Danaher-owned company said the software will complement its flow cytometer and help manage more complex workflows.
By Nick Paul Taylor • June 05, 2019 -
Multi-cancer blood test shows early promise at ASCO
Grail, with backers including Amazon, Bill Gates, Alphabet venture arm GV, J&J and Celgene, said it would move forward with testing based on positive early data presented in a poster at the cancer meeting.
By Susan Kelly • June 03, 2019 -
11.9M Quest Diagnostics patients potentially exposed to data breach
Financial, medical and other personal information, such as Social Security numbers, may have been exposed, the company reported Monday morning.
By David Lim • June 03, 2019 -
Resolution lands FDA breakthrough nod for liquid biopsy
The company says Resolution HRD could be the first approved test of its kind capable of detecting gene deletions from cell-free DNA.
By Nick Paul Taylor • May 31, 2019 -
Qiagen launches companion test for Novartis breast cancer treatment
The diagnostic test aids in identifying HR+/HER2- breast cancer patients with a PIK3CA mutation who may benefit from treatment with Novartis' newly approved Piqray.
By Susan Kelly • May 29, 2019 -
Verily creates machine learning tool to aid diagnostic development
DeepMass expanded the coverage of known biomarkers when applied to clinical data.
By Nick Paul Taylor • May 29, 2019 -
Extragenital tests for chlamydia and gonorrhea get FDA nod
The products from Hologic and Cepheid are the first authorized to test samples from the throat and rectum, methods that could help more people get screened and treated faster.
By Susan Kelly • May 24, 2019 -
Test kit to speed diagnosis of joint replacement infections wins De Novo
FDA thinks the product from CD Diagnostics, acquired by Zimmer Biomet in 2016, will help doctors decide if patients need to undergo revision surgery.
By Maria Rachal • May 24, 2019 -
FDA authorizes Zika test, mulls revoking emergency clearances
The agency granted the first non-emergency marketing authorization for a Zika virus diagnostic to InBios.
By Nick Paul Taylor • May 24, 2019 -
Faulty platelet counts trigger Class I recall of Beckman Coulter devices
FDA is aware of more than 2,000 U.S. laboratories that may be affected by the inaccurate platelet counting but, so far, the agency hasn't received any reports of serious adverse events.
By Nick Paul Taylor • May 24, 2019
