According to the FDA, IVD devices are tests performed on samples taken from the human body. They could be everything from blood tests processed in labs to home COVID-19 or pregnancy tests to continuous glucose monitors using tiny sensors stuck under to skin to measure blood glucose — and much more.
Here are five IVD innovation stories that have caught our attention so far this year:
5. Hologic wins FDA clearance for COVID-flu-RSV assay
Last winter, the U.S. and other countries dealt with a “tripledemic” of COVID-19, influenza, and RSV. So it was welcome news in May when Hologic announced FDA 510(k) clearance of its Panther Fusion SARS-CoV-2/Flu A/B/RSV assay. The news came months after the FDA granted an emergency use authorization for a COVID/flu/RSV test from BD.
Read the full story about Hologic here.
4. FDA approves BD HPV assay for use with Hologic ThinPrep Pap test
“Being able to identify high-risk HPV31 individually is critical to the detection and prevention of cervical cancer,” said Brooke Story, worldwide president of integrated diagnostics solutions for BD. “HPV31 poses the second-highest risk for cervical pre-cancer, and the BD Onclarity HPV Assay is the only FDA-approved assay that screens for it individually.”
3. Exact Sciences launches cancer therapy selection test
OncoExTra uses next-generation sequencing to assess a tumor’s RNA and DNA. According to Exact Sciences, it provides information that informs treatment decisions and uncovers variants possibly missed by only evaluating DNA.
2. Dexcom’s next-gen G7 CGM launches in the U.S.
Dexcom’s latest continuous glucose monitor (CGM) features a 60% size reduction from the previous generation, the G6. It includes a 30-minute warmup period, down from waiting two hours for glucose readings to begin in the past. Meanwhile, competitor Medtronic’s Diabetes business is working on a next-generation CGM sensor that is half the size of the company’s present sensor.
Read the full story about Dexcom here.
1. FDA clears Abbott’s blood test for concussion
The test is now widely available to U.S. hospitals, running on the Abbott Alinity i laboratory instrument. According to Abott, the test provides clinicians with an objective way to quickly assess mild TBIs, otherwise known as concussions.
