Diagnostics
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Ancestry takes on 23andMe, rolls out genetic health test services
The company will be working with Quest Diagnostics and Illumina to sell the laboratory developed tests. It does not currently have a relationship with LabCorp, according to an executive.
By David Lim • Oct. 15, 2019 -
Medical software makers get new guidance on MDR, IVDR
The European Commission's Medical Device Coordination Group aims to clarify which software will be subject to the new regulations, and how those products should be classified and placed on the market.
By Dana Elfin • Oct. 14, 2019 -
FDA clears first rapid Ebola virus diagnostic
Risk of flare up remains, but the United Nations called the outbreak responsible for killing 2,100 people over 14 months in the Democratic Republic of the Congo "significantly contained."
By Nick Paul Taylor • Oct. 11, 2019 -
CDS software, labels for staplers and breast implants among FDA 2020 guidance priorities
The annual publication comes days after the White House issued an executive order aimed at limiting agency use of the documents.
By David Lim • Oct. 11, 2019 -
Experimental cancer IVD trial guidance finalized
AdvaMed won many many of the changes it sought during the comment period, including ones related to communication with the FDA.
By Nick Paul Taylor • Oct. 10, 2019 -
Fresenius to pay $5.2M to settle Medicare overbilling allegations
DOJ alleged the company overbilled Medicare for more than seven years by ordering hepatitis B tests for patients it knew to be immune to the virus.
By Nick Paul Taylor • Oct. 10, 2019 -
Qiagen taps new CEO, restructures in 'clearly a bad day'
The company is also suspending next-generation sequencing-related instrument development as it pivots into a 15-year partnership with Illumina to develop in vitro diagnostic kits.
By David Lim • Oct. 08, 2019 -
Lantheus strikes deal to buy Progenics, sparking investor backlash
Velan Capital, a big shareholder in Progenics, accused management of selling at a "massive discount" and preventing investors from being heard.
By Nick Paul Taylor • Oct. 03, 2019 -
LabCorp Diagnostics names Ratliff as new CEO
John Ratliff, currently the CEO of LabCorp's drug development business, will take the helm of a diagnostics business that notched $1.76 billion in revenue during the second quarter.
By David Lim • Oct. 03, 2019 -
FDA designates AI software meant to boost ultrasound accessibility a breakthrough device
Led by Livongo and 23andMe veteran Andy Page, newly rebranded Caption Health anticipates pivotal data on its tech will be published in early 2020."
By Maria Rachal • Oct. 01, 2019 -
DOJ charges 35 people in $2.1B Medicare genetic testing fraud scheme
CMS also announced it took adverse administrative action against CGx testing companies and providers who filed more than $1.7 billion in claims to Medicare.
By David Lim • Sept. 30, 2019 -
AI just as effective as docs in medical imaging, study suggests
Still, researchers cautioned that the data is sparse and warned against sweeping conclusions, noting "the narrow public body of work comparing AI to human physicians."
By Rebecca Pifer • Sept. 25, 2019 -
EU changes for IVDs called a 'sea change,' revolutionary
The new in vitro diagnostic regulation, slated to come into effect May 2022, will for the first time subject as many as 90% of these diagnostics to review. Previously, most companies could self-certify.
By Dana Elfin • Sept. 23, 2019 -
Medtechs keep shareholders happy, potentially at pipeline's expense: EY
The industry recorded its highest revenues ever within the last year, an analysis by the consultancy shows. Even as R&D spending grew 11%, those investments fell short of the proportion of cash returned to investors.
By Maria Rachal • Sept. 23, 2019 -
FDA lowers Cologuard age to 45, adding 19M to Exact's screening market
The labeling change, which some analysts say represents a more than $3 billion annual revenue opportunity, brings Exact Sciences' flagship product in line with updated screening guidelines for colorectal cancer.
By Maria Rachal • Sept. 23, 2019 -
Adaptive lands deal to provide NGS-based cancer tests to Amgen
The giant biotech will pay annual development fees, sequencing payments and regulatory milestones that could amount to a notable source of revenue for Adaptive.
By Nick Paul Taylor • Sept. 19, 2019 -
Quest didn't steal Cedars-Sinai blood test in trade secrets row, jury says
Hospitals are increasingly using intellectual property to spur transition of early-stage discoveries into products that can be commercialized through licensing agreements.
By Dana Elfin • Sept. 16, 2019 -
Nurses, physician assistants rarely interpret diagnostic images, study finds
Researchers at Emory University said the analysis suggests a need for standardized, focused training programs for non-physician professionals to formally define their roles.
By Susan Kelly • Sept. 16, 2019 -
Abbott says AI technology can help diagnose heart attacks
A study in the journal Circulation concluded the algorithm, which aims to individualize testing by taking into account factors such as patient age and sex, performed better than the European Society of Cardiology rule-out pathway.
By Susan Kelly • Sept. 11, 2019 -
FDA finalizes guidance on HDEs after AdvaMed scrutiny
Industry advocates had criticized FDA's tight parameters on which humanitarian use devices are eligible to turn a profit, but the final guidance largely mirrors the draft.
By Susan Kelly • Sept. 06, 2019 -
Prescient gets FDA breakthrough status for colorectal cancer test
If eventually approved, the test's competition includes Exact Sciences' Cologuard and an older test for blood in fecal samples.
By Nick Paul Taylor • Sept. 05, 2019 -
Laboratory for Advanced Medicine's liver cancer test gets FDA breakthrough tag
The company secured the status after showing the test detects hepatocellular carcinoma with a specificity and sensitivity in excess of 95%.
By Nick Paul Taylor • Sept. 04, 2019 -
Abbott touts potential of 15-minute concussion detection
Highlighting research from the TRACK-TBI study, the company said its in-development point-of-care test could help diagnose concussion in patients whose CT scans miss signs of mild traumatic brain injury.
By Maria Rachal • Aug. 27, 2019 -
Deep DivePharmacogenetic test makers cheer UnitedHealth coverage. Other payers aren't there yet.
"I've been concerned that the hype around pharmacogenetics, at least for depression, has gotten out ahead of the data," James Potash, director of psychiatry at the Johns Hopkins University, said.
By Graison Dangor • Aug. 27, 2019 -
Lawmakers to update VALID this fall, but industry still clashing over details
With Republican Sen. Richard Burr as a new lead sponsor, Congress is working toward releasing an updated Leading-edge IVCT Development Act in the coming months, multiple sources familiar with the issue told MedTech Dive.
By David Lim • Aug. 26, 2019
