Cold War law invoked for BD, Quidel to prioritize antigen test contracts

The Trump administration's use of the Defense Production Act comes amid rising demand for the tests that can be less accurate than traditional molecular diagnostics, but offer results within minutes.

By Nick Paul Taylor • Aug. 21, 2020

House panel demands HHS briefing on decision to nix premarket review for COVID-19 lab developed tests

On Thursday, Energy and Commerce Chairman Frank Pallone, D-N.J., insisted the department explain its "deeply concerning" decision to allow coronavirus LDTs to come to market without FDA review.

By Greg Slabodkin • Updated Aug. 21, 2020

Explore the Trendline➔

New medical devices are reshaping the medtech industry

From pulsed field ablation devices to glucose sensors and surgical robotics, new medical technologies are transforming patient care and how people manage their health.

By MedTech Dive staff

IDx rebrands, buys 3Derm to expand automated AI portfolio

The takeover gives the company, now known as Digital Diagnostics, control of two breakthrough device-designated autonomous artificial intelligence systems.

By Nick Paul Taylor • Aug. 20, 2020

LumiraDx lands FDA's third COVID-19 antigen test EUA, as demand for rapid diagnostics rises

William Blair analysts questioned the immediate impact from the nod to the relatively small medtech, and instead looked ahead to the next potential big player to enter the market: Abbott.

By Nick Paul Taylor • Aug. 20, 2020

Why it's taken Quest so long to clear its COVID-19 testing backlog

The lab giant trailed chief rival LabCorp in turnaround times for most of July, slowed down by geography and the makeup of its customer base. Quest finally caught up this week, reporting average test results in one to two days.

By Greg Slabodkin • Aug. 18, 2020

FEMA pitches voluntary DPA pact to bolster medical supply chain during pandemic

The Defense Production Act allows private companies to enter agreements with the government while avoiding antitrust liability. AdvaMed wants to participate but FEMA has not yet extended an invite.

By Greg Slabodkin • Aug. 18, 2020

Thermo Fisher COVID-19 test flagged for false positive and negative results

An FDA alert on Monday follows a quarter in which coronavirus-related products added $1.3 billion to the medtech's sales, and after it scored an HHS contract to provide processing instruments to labs.

By Nick Paul Taylor • Aug. 18, 2020

Abbott, Roche COVID-19 antibody tests may mislead on immunity, study suggests

The MD Anderson study is the latest to question the value of such tests and note the risk they may lead people to incorrectly believe they are immune from further infection.

By Greg Slabodkin • Aug. 17, 2020

FDA OKs Yale COVID-19 saliva test removing RNA extraction step

While the agency called the method potentially groundbreaking, one public health expert cautioned that the assay must be performed in highly specialized labs and is not considered a rapid test.

By Nick Paul Taylor • Aug. 17, 2020

HHS commits $6.5M to add Thermo Fisher, Beckman Coulter COVID-19 test supplies to Aegis, Sonic labs

The federal funding to scale testing, still dwarfed by government spending on vaccines, came the same week labs and providers urged the administration to update testing prioritization guidelines given limited resources.

By Greg Slabodkin • Aug. 14, 2020

Surgical robots, early cancer tests top CB Insights digital health startup list

The most promising, as aggregated in annual rankings from the firm, have raised over $20 billion in total funding for more than 600 deals with 900-plus investors.

By Hailey Mensik , Maria Rachal • Aug. 14, 2020

Myriad names new CEO, reports sales sank 57% amid COVID-19 shutdowns

The beleaguered molecular diagnostic company had competitive weaknesses prior to the pandemic that remain unresolved. But SVB Leerink analysts contend Paul Diaz’s appointment could help it "turn the corner."

By Nick Paul Taylor • Aug. 14, 2020

Thermo Fisher-Qiagen deal falls apart after failing to secure shareholder support

Thermo Fisher recently raised its bid for Qiagen shares, taking into account the company's COVID-19 testing gains. But when the offer expired Monday, less than half of shares were tendered.

By Nick Paul Taylor , Maria Rachal , Greg Slabodkin • Updated Aug. 13, 2020

Hologic jumps into COVID-19 pool testing, aimed at boosting lab capacity

LabCorp and Quest last month announced their own specimen pooling methods. Unlike Hologic, however, they have already been granted emergency use authorizations by FDA. 

By Nick Paul Taylor • Aug. 12, 2020

State coronavirus testing targets diverge, some plan declines by December

Monthly testing goals submitted to HHS show Connecticut and Illinois are among those looking to multiply monthly testing volumes, while Louisiana and Maine, for example, are projecting lower levels at the end of the year.

By Maria Rachal • Aug. 11, 2020

Guardant companion diagnostic gets FDA nod as 1st liquid biopsy with NGS

Cowen analysts noted Guardant360 will be reimbursed under an existing Medicare national coverage determination for genetic profiling using next-generation sequencing, predicting initial reimbursement at around $3,500.  

By Susan Kelly • Aug. 10, 2020

Notified bodies list for incoming EU regs hits 20 with designation of DQS for MDR

The 16 notified bodies now allowed to complete work under the Medical Device Regulation and the four OK'd under its In Vitro Diagnostic counterpart together meet the goal that authorities had hoped to achieve by the start of 2020.

By Nick Paul Taylor • Aug. 10, 2020

Healthcare gains jobs in July, but still down 800K from February

The latest report shows ambulatory, outpatient, and medical and diagnostic lab service jobs are creeping closer to last year's levels.

By Hailey Mensik • Aug. 7, 2020

Guardant growth slows in Q2 but still beats expectations

The precision oncology company reported a 23% increase in sales, yet refrained from reinstating full-year guidance amid ongoing uncertainty about the impact of COVID-19. 

By Nick Paul Taylor • Aug. 7, 2020

BD sales slide below expectations, as COVID-19 antigen test gains momentum

In the month since the launch of its antigen test, CEO Tom Polen said BD shipped more Veritor readers than in a typical year. Still, the medtech's stock fell 9% Thursday amid pressure on other business lines.

By Greg Slabodkin • Aug. 6, 2020

10 states now on board to buy Quidel, BD antigen tests

With the latest additions of Arkansas and Rhode Island, there are now five Democratic and five Republican governors each planning to acquire half a million of the rapid point-of-care diagnostics from the medtechs.

By Greg Slabodkin • Updated Aug. 19, 2020

Americas drag on Qiagen as Thermo Fisher deal goes down to the wire

A hedge fund that owns 8% of Qiagen "fully" expects the Thermo Fisher offer to fail, calling it “wholly inadequate.”

By Nick Paul Taylor • Aug. 5, 2020

CMS proposes eliminating inpatient-only list, in potential boon for ASCs

The agency would begin by removing about 300 musculoskeletal-related services, which could further accelerate ambulatory surgery centers' important role as medtech customers.

By Shannon Muchmore • Aug. 4, 2020

Device maker Q2 reports show optimism on COVID-19 recovery, but flare-ups keep guidance at bay

Since March and April lows, business volume has improved sequentially. Still, many medtechs are tightlipped on what that may mean for financial performance for the rest of the year.

By Maria Rachal • Aug. 3, 2020

Quidel says COVID-19 antigen test buoys 270% rise in rapid diagnostics unit, demand 'more than we can satisfy'

The company late Thursday reported second quarter total sales of $201.8 million, an 86% increase over the prior year, with strong demand for its PCR and antigen tests for the coronavirus.

By Greg Slabodkin • Updated July 31, 2020