Boutique Diagnostics

Digital Health Market Access Consulting Firm

Digital Health Solutions

May 2021: What’s new in the world of diagnostics?

Coverage, Policy, and Regulatory

 1.       US panel trims colorectal cancer screening age, broadening payer mandate

The U.S. Preventive Services Task Force has finalized its position on screening for colorectal cancer, confirming that adults aged 45 years and up should be tested. Exact Sciences has framed the guidance as a chance to drive growth by targeting 19 million people in the screening cohort.

2.       NICE’s Office for Digital Health opens its doors

The in-house team of advisors has been set up to spearhead its policy on digital health technologies (DHTs) – including apps, programs, and software.

3.       Bundestag passes another digitization law

The "Digital Supply and Care Modernization Act" (DVPMG) was passed by the Bundestag. The law provides further development of digital health applications, expansion of telemedicine, additional application options in telematics infrastructure and the promotion of digital networking.

4.       Illumina sues European Commission to block competition probe into Grail buyout

Illumina has filed for an annulment of the European Commission's decision to assess the proposed takeover of Grail. The manufacturer is trying to buy back Grail to boost its presence in the liquid biopsy.

5.       Government to develop global standards for genomic data sharing

The government aims to develop global standards and policies for genomic health data sharing, aiming to make the UK a global leader in the area.

6.       MDR challenges remain as regulation goes into effect: MedTech Europe

While the MDR went live on the 26th of May, MedTech Europe warned that hurdles still limit the industry’s ability to "seamlessly supply certified devices under the new rules." 

 

New Products, Partnerships, Discoveries

1.       Guardant’s Partnership with Janssen Bears Fruit

The company expanded its arsenal when it won a nod from FDA to use the Guardant 360 CDx as a companion diagnostic for Janssen Pharmaceutical’s Rybrevant (NSCLC).

2.       NeoGenomics inks $390M Inivata buyout to enter liquid biopsy space

The takeover will give NeoGenomics full ownership of InVisionFirst-Lung, a lung cancer panel that it already commercializes in the US.

3.       Japanese firms Sysmex and ThinkCyte team up to develop AI-powered tech for IVD
Sysmex has signed a deal with ThinkCyte for the production and sale of a new AI-based cell analysis technology for in-vitro diagnostics.

4.       Anthem, Epic launch data-sharing partnership

Anthem and Epic announced a collaboration expanding bidirectional data exchange to give providers more real-time data on patient behaviors such as medication adherence.

5.       Bayer backs Ada Health’s symptom checker app in $90m financing

Ada Health has received another endorsement for its app to help patients diagnose conditions from symptoms, raising an impressive $90 million in funding from investors including Bayer.

6.       CVS Health eyes early-stage companies with $100M digital health fund

CVS Health Ventures will target digital health solutions that focus on making healthcare more accessible, affordable and simple.

7.       Google AI tool can help patients identify skin conditions

Google has unveiled a tool that uses artificial intelligence to help spot skin, hair and nail conditions, based on images uploaded by patients.

8.       Babylon continues buying spree with another California-based practice

Babylon Health is making a big push into the U.S. with its purchase of another California-based practice.

9.       Vinehealth earns CE marks for cancer management apps

The UK digital health firm won a CE mark for a mobile app that helps cancer patients manage their medications and care, as well as its web-based app for clinicians.