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Genomics/Molecular Diagnostics

Grail, Quest Diagnostics to collaborate on Galleri multi-cancer early detection blood test

February 24, 2021 By Sean Whooley Leave a Comment

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 […]

Filed Under: Blood Management, Business/Financial News, Diagnostics, Featured, Genomics/Molecular Diagnostics, Oncology Tagged With: Grail, Quest Diagnostics Inc.

Truvian closes $105M oversubscribed Series C

February 24, 2021 By Sean Whooley Leave a Comment

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 […]

Filed Under: Blood Management, Business/Financial News, Diagnostics, Featured, Funding Roundup, Genomics/Molecular Diagnostics Tagged With: Personnel Moves, Truvian Sciences

Hologic completes Biotheranostics acquisition

February 23, 2021 By Sean Whooley Leave a Comment

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 […]

Filed Under: Business/Financial News, Diagnostics, Featured, Genomics/Molecular Diagnostics, Mergers & Acquisitions, Women's Health Tagged With: bioTheranostics, Hologic

FDA issues guidelines to address COVID-19 variants

February 22, 2021 By Sean Whooley Leave a Comment

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 […]

Filed Under: Business/Financial News, Diagnostics, Featured, Food & Drug Administration (FDA), Genomics/Molecular Diagnostics, Pharmaceutical, Regulatory/Compliance Tagged With: BioNTech, coronavirus, COVID-19, COVID-19 vaccine, COVID-19 variants, FDA, Moderna, Pfizer

BD, Scanwell Health collaborating on smartphone-enabled, home COVID-19 rapid test

February 22, 2021 By Sean Whooley Leave a Comment

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, […]

Filed Under: Business/Financial News, Diagnostics, Digital Health, Featured, Genomics/Molecular Diagnostics, Health Technology, Research & Development, Software / IT Tagged With: BD, becton dickinson, coronavirus, COVID-19, Scanwell Health

MedTech 100 roundup: Slight dip after all-time best for industry

February 22, 2021 By Sean Whooley Leave a Comment

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. […]

Filed Under: Business/Financial News, Diagnostics, Featured, Food & Drug Administration (FDA), Funding Roundup, Genomics/Molecular Diagnostics, Mergers & Acquisitions, Regulatory/Compliance, Wall Street Beat Tagged With: Butterfly Network, coronavirus, COVAX, COVID-19, FDA, Henry Schein One, Joe Biden, Mainstay Medical, MedTech 100 Index, Medtronic, Personnel Moves, Retractable Technologies Inc., Zimmer Biomet

FDA lets Everlywell sell its COVID-19 home collection kit direct to consumers

February 17, 2021 By Sean Whooley Leave a Comment

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 […]

Filed Under: Diagnostics, Featured, Food & Drug Administration (FDA), Genomics/Molecular Diagnostics, Regulatory/Compliance Tagged With: coronavirus, COVID-19, Everlywell, FDA

FDA issues EUA for Thermo Fisher Scientific COVID-19, flu combo test

February 16, 2021 By Sean Whooley Leave a Comment

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, […]

Filed Under: Diagnostics, Featured, Food & Drug Administration (FDA), Genomics/Molecular Diagnostics, Regulatory/Compliance Tagged With: coronavirus, COVID-19, FDA, Thermo Fisher Scientific

Visby Medical wins FDA authorization for point-of-care COVID-19 PCR test

February 10, 2021 By Sean Whooley

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 […]

Filed Under: Diagnostics, Featured, Food & Drug Administration (FDA), Genomics/Molecular Diagnostics, Regulatory/Compliance Tagged With: coronavirus, COVID-19, FDA, Visby Medical

ProPhase Labs debuts single saliva test for COVID, flu

February 9, 2021 By Sean Whooley

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 […]

Filed Under: Diagnostics, Featured, Genomics/Molecular Diagnostics Tagged With: coronavirus, COVID-19, FDA, ProPhase Labs, Spectrum Solutions

Becton Dickinson beats The Street, raises 2021 guidance

February 4, 2021 By Sean Whooley

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 […]

Filed Under: Business/Financial News, Diagnostics, Featured, Genomics/Molecular Diagnostics, MassDevice Earnings Roundup, Wall Street Beat Tagged With: BD, becton dickinson, coronavirus, COVID-19

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