Grail announced that it entered into an agreement with Quest Diagnostics (NYSE:DGX) to collaborate on Grail’s Galleri multi-cancer blood test. Quest Diagnostics is slated to provide phlebotomy services in support of the Galleri multi-cancer early detection blood test, according to a news release. Menlo Park, Calif.-based Grail completed enrollment for the Pathfinder prospective study of Galleri in […]
Genomics/Molecular Diagnostics
Truvian closes $105M oversubscribed Series C
Truvian Sciences announced today that it closed an oversubscribed Series C financing round worth more than $105 million. TYH Ventures, Glen Tullman of 7wireVentures and Wittington Ventures led the funding round, the proceeds from which are earmarked for the development of Truvian’s automated benchtop blood testing system, according to a news release. The benchtop system […]
Hologic completes Biotheranostics acquisition
Hologic (NSDQ:HOLX) announced that it completed its previously announced acquisition of Biotheranostics for $230 million. Marlborough, Mass.-based Hologic last month announced that it was set to buy Biotheranostics and its two molecular diagnostic tests for breast and metastatic cancers, the Breast Cancer Index and CancerTYPE ID. Both laboratory-developed tests are not required to be cleared by […]
FDA issues guidelines to address COVID-19 variants
The FDA today issued guidance for medical product developers to address the emergence of variants of SARS-CoV-2, which causes COVID-19. Variants of the virus have been detected in multiple countries across the globe, including the U.S., and they pose a major threat to potentially ending the COVID-19 pandemic as protocols such as mask-wearing and hand-washing […]
BD, Scanwell Health collaborating on smartphone-enabled, home COVID-19 rapid test
Becton Dickinson (NYSE:BDX) announced today that it is collaborating with Scanwell Health to create an at-home rapid COVID-19 test. Scanwell Health, a developer of smartphone-enabled at-home medical tests, will offer its mobile app to pair with a BD antigen test for SARS-CoV-2, the virus causing COVID-19, according to a news release. As part of the collaboration, […]
MedTech 100 roundup: Slight dip after all-time best for industry
The medtech industry’s stocks rose higher than they ever had to begin last week before eventually dropping to a slightly more normal level. MassDevice‘s MedTech 100 index ended the week (Feb. 19) at 108.72 points, marking a -1.7% dip from the 110.63-point mark set at the end of the previous week (Feb. 12). On Monday (Feb. […]
FDA lets Everlywell sell its COVID-19 home collection kit direct to consumers
Everlywell announced today that it received FDA emergency use authorization for its COVID-19 test home collection kit DTC. Under EUA, the home collection kit made by Everlywell can now be used directly by individuals who are not experiencing symptoms and have no suspected exposure and who are without a doctor’s prescription, according to a news […]
FDA issues EUA for Thermo Fisher Scientific COVID-19, flu combo test
Thermo Fisher Scientific (NYSE:TMO) announced today that it received FDA emergency use authorization (EUA) for a COVID-19/flu combo test. Carlsbad, Calif.-based Thermo Fisher’s Applied Biosystems TaqPath COVID-19, Flu A, Flu B combo kit is a real-time PCR test for detecting and differentiating RNA from SARS-CoV-2, influenza A and influenza B viruses in nasopharyngeal and nasal swabs, […]
Visby Medical wins FDA authorization for point-of-care COVID-19 PCR test
Visby Medical announced today that it received FDA emergency use authorization (EUA) for its rapid COVID-19 test at point-of-care. San Jose, Calif.-based Visby’s rapid PCR COVID-19 test received EUA previously but can now be used by any organization with a Clinical Laboratory Improvement Amendments (CLIA) certificate of waiver, according to a news release. Visby’s testing […]
ProPhase Labs debuts single saliva test for COVID, flu
ProPhase Labs (NSDQ:PRPH) announced today that it is introducing a new saliva-based test for COVID-19, Influenza A, B and more. Garden City, N.Y.-based ProPhase Labs said in a news release that it filed for FDA emergency use authorization for its two new testing methodologies, which integrate the Spectrum Solutions saliva self-collection system with a new […]
Becton Dickinson beats The Street, raises 2021 guidance
Becton Dickinson (NYSE:BDX) shares dipped slightly despite first-quarter results that came in well above the consensus forecast. The Franklin Lakes, N.J.-based company posted profits of $981 million, or $3.35 per share, on sales of $5.3 billion for the three months ended Dec. 31, 2020, tripling its bottom-line on sales growth of 25.8%. Adjusted to exclude one-time […]
