Diagnostics: Page 2

Comparisons of COVID-19 saliva, swab tests paint mixed picture

Study findings published the same day in the New England Journal of Medicine and Annals of Internal Medicine have conflicting messages on saliva tests, which FDA has greenlit from developers including Fluidigm and Phosphorus.

By Nick Paul Taylor • Aug. 31, 2020

Abbott gets $760M contract from HHS to deliver 150M antigen tests

The deal comes just one day after the company's antigen test received FDA emergency use authorization. BD, Quidel and LumiraDx previously got the agency's nod for their diagnostics.

By Greg Slabodkin • Aug. 28, 2020

Foundation Medicine wins FDA OK for pan-tumor test as liquid biopsy market heats up

The approval for the FoundationOne Liquid CDx follows the agency's nod earlier this month for Guardant Health's next-generation sequencing diagnostic.

By Greg Slabodkin • Aug. 27, 2020

Abbott gets EUA for rapid $5 COVID-19 antigen test

As the fourth company to get the FDA emergency nod, the medtech giant's scale makes it a "significant entry [that] could help democratize testing," said former agency head Scott Gottlieb.

By Nick Paul Taylor • Aug. 27, 2020

Freenome raises $270M to run pivotal trial of colorectal cancer liquid biopsy

The 14,000-subject study could set the company up to compete with Exact Sciences and Guardant Health for the colorectal cancer screening market.

By Nick Paul Taylor • Aug. 26, 2020

FDA-industry group touts real-world evidence framework to speed test development

The Medical Device Innovation Consortium, a collaboration between FDA and diagnostics makers like Abbott and Roche, offers a roadmap as COVID-19 accelerates use of newly generated data to update emergency authorizations. 

By Susan Kelly • Aug. 25, 2020

Q&A

MedTech Europe beats drum for virtual audits, IVDR delay

The one-year delay to the EU Medical Device Regulation has been crucial, but there's been "radio silence" from lawmakers on calls for a similar delay to the In Vitro Diagnostic Regulation, said regulatory lead Oliver Bisazza.

By Maria Rachal • Aug. 24, 2020

Ex-Trump FDA chief rails against new HHS policy on lab developed tests

Scott Gottlieb took to Twitter on Saturday criticizing last week's decision by the administration that FDA will no longer require premarket review of LDTs. "FDA’s ability to protect public health could be challenged," he warned. 

By Greg Slabodkin • Aug. 24, 2020

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 at 12:02 p.m.

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 at 11:39 a.m.

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