New Products, Partnerships, Discoveries
1. FTC challenges Illumina-Grail deal, putting $7B merger in jeopardy
The Federal Trade Commission has moved to block Illumina's $7.1 billion takeover of Grail on the grounds it will "harm competition in the U.S. market for life-saving multi-cancer early detection (MCED) tests. Exact Sciences, a competitor in the same space, is expected to benefit.
2. Roche to buy GenMark for $1.8B to add multiplex testing
The Swiss company said the deal will give it access to a novel technology for testing a range of pathogens with one patient sample.
3. IQVIA pays Quest Diagnostics $760M to get full control of central lab joint venture
The laboratory services joint venture that IQVIA and Quest Diagnostics have operated for the past six years is moving under the full control of IQVIA in a $760 million transaction.
4. Liquid biopsies dominate FDA's latest breakthrough device nods
Liquid biopsy developers feature heavily in the latest round of FDA breakthrough designations, with Natera, Inivata and Bluestar Genomics all securing the status for their blood-based cancer tests.
5. New Liquid Biopsy Test Gives Revealing Look at Recurrent Colorectal Cancer
Guardant Health is launching a liquid biopsy test for the detection of residual and recurrent colorectal cancer.
6. Liquid biopsy device aiming to revolutionise cancer diagnosis
BioCaptiva has developed a medical device that captures cfDNA (circulating free DNA) from the blood of patients in much greater quantities than the current standard of a single blood draw can, overcoming a significant current limitation of cancer liquid biopsy testing.
7. Hillrom faces lawsuit after dropping planned $375M Bardy Diagnostics deal
Hillrom announced its decision on Monday after Medicare Administrative Contractor Novitas Solutions slashed reimbursement for long-term cardiac monitoring.
8. FDA Allows for First Point-of-Care Chlamydia and Gonorrhea Test
It will allow the use of the Binx Health IO CT/NG Assay at point-of-care settings, such as in physician offices, community-based clinics, urgent care settings, outpatient healthcare facilities and other patient care settings.
9. German Specialist society wants higher quality standards for tests for occult blood in stool
According to the German Society for Gastroenterology, Digestive and Metabolic Diseases, the immunological test delivers reliable results if it is used correctly. But there are currently around a dozen tests on the market that differ greatly in several respects.
10. NHS trials genomic testing to predict risk of heart disease
UK biotech firm Genomics plc is working with the NHS on a pilot study using genetic information to predict patients’ risk of heart disease. Around 1,000 people in north-east England who attend routine GP health checks, will take part in the trial.
Policy and Regulatory
1. Companion diagnostics in oncology: In the hospital only with improvisational skills
In Germany, companion diagnostics services and other biomarker analyses are not or only insufficiently taken into account in the flat-rate billing system for inpatient care.
2. European ecosystem for health tech launched by Sanofi, Capgemini, Generali and Orange
The project aims to bring together scientific and technological expertise across the region and to strengthen France's position in the health technology sector.
3. Germany’s DiGA - Secure data in the cloud?
A recent document released by the German Federal Institute for Drugs and Medical Devices (BfArM) has revealed that despite the invalidated Privacy Shield there are exemptions in place for Germany to allow data storage from digital health applications, so-called DiGAs, in European and even US clouds under specific terms.