Diagnostics: Page 2

Dispute over monkeypox test reimbursement rates may hurt effort to halt disease’s spread: experts

The CMS says regional administrators can set prices, even as lab group warns fees are too low for commercial firms to conduct testing.

By Elise Reuter • Aug. 31, 2022

Illumina opens first manufacturing facility in China to supply gene sequencing products

The company aims to produce all gene sequencing instruments and consumables locally within five years in a bid to expand its presence in the growing Chinese market.

By Nick Paul Taylor • Aug. 31, 2022

Explore the Trendline➔

Medical device industry continues to turn to digital health, AI

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

By MedTech Dive staff

Olympus to sell microscope unit for $3.1B as it bolsters focus on medical technology

Bain Capital has taken the other side of the deal, paying $3.1 billion for a business it said is “at the frontier of digital optical technology in life sciences and industrial end markets.”

By Nick Paul Taylor • Aug. 30, 2022

Labcorp adds to hospital lab buying streak with New Jersey acquisition

The purchase comes as hospitals work to trim costs and testing firms seek stable revenue streams as COVID-19 testing winds down.

By Peter Green , Rebecca Pifer • Aug. 25, 2022

Lab group ACLA warns ‘inadequate’ payment rates may limit access to monkeypox testing

The trade group urged the CMS to ensure monkeypox testing claims are paid at its “reasonably derived” recommended rate to ensure access to testing.

By Nick Paul Taylor • Aug. 23, 2022

Abbott blood test predicts death, unfavorable outcomes in traumatic brain injury patients, study finds

Abbott is pursuing FDA clearance for the breakthrough-designated TBI test to expand access to a diagnostic that predicted death and severe disability.

By Nick Paul Taylor • Aug. 12, 2022

As monkeypox cases increase, disease experts lament lack of testing access

“It’s the same problem that happened with COVID-19. This is exactly identical,” said Amesh Adalja, a senior scholar at the Johns Hopkins Center for Health Security in Baltimore.

By Elise Reuter • Aug. 10, 2022

Roundup: Medical device industry confident it can ride out recession, wary of slowing capital sales

While companies may weather a recession, they still face challenges like hospital staffing shortages, supply chain disruption and inflation, RBC Capital Markets analysts wrote.

By Nick Paul Taylor • Updated Aug. 10, 2022

Senate passes $740B bill to lower healthcare costs after months of wrangling

While Republicans successfully challenged a planned $35 insulin price ceiling for patients on private insurance, the law still has implications for makers of diabetes devices.

By Nick Paul Taylor • Aug. 8, 2022

FDA’s breakthrough device designations poised for another record year

At the midpoint of the year, the FDA had granted 129 designations, suggesting it will break the previous full-year record of 206.

By Nick Paul Taylor • Aug. 8, 2022

QuidelOrtho reports 37.5% sales growth in first quarter since $6B merger

The testing firm is increasing sales after Quidel merged with Ortho, opening opportunities to cut costs and increase point-of-care and molecular diagnostics revenue.

By Nick Paul Taylor • Aug. 5, 2022

Biden administration declares monkeypox a public health emergency

Federal health officials said Thursday that U.S. monkeypox testing capacity is at about 80,000 tests per week, although only 10% of capacity is currently being used.

By Ricky Zipp • Aug. 4, 2022

BD’s base business growth in Q3 offset by drop in COVID-19 testing

The company reported a year-over-year drop of about $224 million in COVID-19 testing revenue compared to 2021, with the testing slowdown expected to continue. 

By Ricky Zipp • Aug. 4, 2022

Siemens Healthineers stumbles as lockdowns, falling COVID-19 sales and rising costs hit business

Lockdowns in China caused a steep decline in equipment orders and a big setback to the firm’s core diagnostic business, even as the company expects to meet full year revenue targets.

By Nick Paul Taylor • Aug. 3, 2022

North American Diagnostics latest to recall COVID-19 tests, gets Class I label from FDA

The recall adds to a list of medtech firms that have been forced to withdraw illegally distributed COVID-19 tests, amid concerns they could yield false results.

By Ricky Zipp • Aug. 2, 2022

Illumina vows to fight EU efforts to block $8B Grail merger

Illumina acquired the liquid biopsy company in 2021, despite pending anti-competitiveness investigations on both sides of the Atlantic.

By Elise Reuter • Updated Aug. 2, 2022

FDA reauthorizes Meridian’s COVID-19 test after changes to enable omicron detection

The renewed emergency use authorization comes as SD Biosensor works to close its $1.53 billion takeover of Meridian.

By Nick Paul Taylor • Aug. 1, 2022

Core diagnostic growth offsets falling COVID-19 sales at Hologic, Thermo Fisher, Qiagen

Rising demand for core diagnostics offset better-than-feared declines in COVID-19 test sales, shedding light on the companies’ post-pandemic futures.

By Nick Paul Taylor • July 29, 2022

Labcorp lowers forecast after Q2 slowdown, will spin off drug development unit

A drop in COVID-19 testing contributed to the company’s second quarter decline, while its base business grew by 1.2% compared to last year.

By Ricky Zipp • July 28, 2022

MedTech Europe pushes for semiconductor prioritization as US moves to increase local supply

The trade group wants political action to stop patient harm from “a growing divergence” between semiconductor supply and demand.

By Nick Paul Taylor • July 27, 2022

Philips shares hit 10-year low as supply chain challenges weigh on revenue

Sleep apnea machine recall adds to woes as sales forecast is slashed for remainder of 2022. 

By Elise Reuter • July 25, 2022

Johns Hopkins sepsis alert tool reduced patient deaths, studies find

Three prospective studies of a machine learning tool developed by a Johns Hopkins spinout found it led to earlier antibiotic treatment and reduced patient mortality.

By Elise Reuter • July 22, 2022

Friday Q&A: Matthew Binnicker, Mayo Clinic's director of clinical virology, talks COVID-19, monkeypox testing

With cases of both viruses rising across the U.S., clinical laboratories are bringing in staff to ramp up monkeypox testing, even as demand falls for clinical diagnostics of COVID-19.

By Elise Reuter • July 22, 2022

Roche CEO Schwan, who guided company as cancer drug powerhouse, to step down next year

The drugmaker’s current diagnostics chief Thomas Schinecker will take over as CEO in March, while Schwan will seek election as chair of Roche’s board.

By Jonathan Gardner • July 21, 2022

Test makers urge House, Senate to include diagnostic reforms in user-fee bill

AdvaMedDx, Abbott and Roche are among companies asking lawmakers to address the “urgent public health issue.”

By Nick Paul Taylor • July 21, 2022