Diagnostics
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Rapid diagnostic test detects Ebola, malaria in the field
The portable test can detect Ebola and other viruses in under 30 minutes from a single blood sample.
By Susan Kelly • Dec. 14, 2018
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Grand jury indicts physician over alleged medical testing fraud
The indictment came days before the government settled a separate fraud case with an audiology practice.
By Nick Paul Taylor • Dec. 13, 2018
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Apple EKG, artificial iris among FDA 2018 device decisions
De Novos are on the rise, but both premarket approvals and 510(k)s appear to be slightly down from 2017, according to nearly year-end data from FDA.
By Meg Bryant • Dec. 12, 2018
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Merck taps Roche for Keytruda companion diagnostic
Roche will develop a test to identify patients with a certain biomarker known to make solid tumors vulnerable to treatment with the checkpoint inhibitor.
By Nick Paul Taylor • Dec. 12, 2018
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Thermo Fisher gets FDA nod for plazomicin immunoassay
The antibiotic, marketed as Zemdri, is used to treat patients with complicated urinary tract infections.
By Susan Kelly • Dec. 11, 2018
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Hologic begins selling 3-in-1 uterine scope
The device is intended to improve the procedure for treating uterine conditions by avoiding the need to change from a diagnostic to an operative scope.
By Susan Kelly • Dec. 11, 2018
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FDA guide unveils vision for cancer diagnostics
The proposal came the same day lawmakers released an updated draft bill that would grant FDA authority to oversee in vitro clinical tests, such as test kits and laboratory developed tests.
By David Lim • Dec. 07, 2018
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FDA endorses open database for genetic variants
The agency said it hopes the move will encourage database administrators to submit genetic variant information to publicly accessible databases, with the aim of spurring advancements in precision medicine.
By Susan Kelly • Dec. 05, 2018
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ACLA appeals lab payment suit to higher court
A watchdog report on Medicare lab payments will not help the industry's case, analysts said.
By David Lim • Dec. 05, 2018
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Medtech R&D adapting under new pressures, industry study shows
The shift to value-based payment models and already tight profit margins are ratcheting up pressure, but the device makers are adjusting their R&D investment strategies in response.
By Susan Kelly • Dec. 04, 2018
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Medicare could overpay billions for lab tests: GAO
Medicare's new method of calculating payment rates for laboratory tests was intended to save the government money but could instead end up costing CMS as much as $10.3 billion over three years.
By Susan Kelly • Dec. 03, 2018
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FDA OKs first test to detect herpes in newborns
The Meridian Bioscience test uses a saliva swab to detect cytomegalovirus DNA and may help identify the virus in newborns more quickly.
By Susan Kelly • Dec. 03, 2018
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LabCorp cuts its profit outlook, citing volume shortfall
The announcement follows a profit warning just two days earlier from rival Quest Diagnostics.
By Susan Kelly • Dec. 03, 2018
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FDA offers more study options for CLIA waivers in redrafted guidances
The agency added new test design alternatives for manufacturers seeking waivers for IVD devices, a nod to a push from AdvaMed and others.
By Maria Rachal • Nov. 30, 2018
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NIST takes early step toward bringing photonic chips into healthcare
The technology opens up new avenues for research by transmitting data via light waves, not electric current.
By Nick Paul Taylor • Nov. 29, 2018
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Fighting for market share, LabCorp and Quest plan expansions
The laboratory testing giants are opening new sites on opposite coasts as they pursue market share gains.
By Nick Paul Taylor • Nov. 29, 2018
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Quest Diagnostics snaps up Midwest lab services business
The New Jersey-based diagnostics company has agreed to acquire Missouri-based Boyce and Bynum Pathology Laboratories, building off of three lab acquisitions last quarter.
By Susan Kelly • Nov. 28, 2018
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Metagenomic sequencing shows promise in diagnosing airway infections
The test zeroed in on causative pathogens in lower respiratory tract infections, which are the leading cause of infectious disease-related deaths globally yet have been notoriously challenging to diagnose.
By Nick Paul Taylor • Nov. 28, 2018
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Beckman initiates Class I recall of flow cytometers
FDA is concerned inaccurate results provided by the devices could lead to serious injuries or deaths.
By Nick Paul Taylor • Nov. 22, 2018
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Millennial to menopausal, women's health is fertile space for startups
Early-stage investors have increased support for female-specific devices and direct-to-consumer diagnostics in the last five years, as the women’s health market is poised to reach $50 billion globally by 2025.
By Maria Rachal • Nov. 14, 2018
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Deep Dive3D printing poised to disrupt healthcare
Health industry types are "100% convinced, and rightly so, that [3D printing] will be a core part of their business in five to 10 years," ISG's Michael Harmon said.
By Meg Bryant • Nov. 12, 2018
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Quest Diagnostics adds Apple Health integration for lab results
The move follows rival LabCorp's deal with Apple to add a similar integration for iPhone users.
By David Lim • Nov. 12, 2018
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FDA clears battery-powered Ebola test for emergency use
The regulatory decision adds to the testing capabilities of public health clinics and treatment centers.
By Nick Paul Taylor • Nov. 12, 2018
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LabCorp loses 2019 Horizon BCBSNJ exclusivity as Quest enters the fray
The deal means the two clinical laboratory giants will compete for some of the New Jersey insurer's members.
By Nick Paul Taylor • Nov. 09, 2018
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ACLA praises CMS for boosting data collection
The clinical lab trade group lauded the agency for taking steps to increase the number of laboratories submitting data informing Medicare payment rates.
By David Lim • Nov. 05, 2018