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Monday, July 6, 2020

Becton Dickinson (BDX) : Rapid antigen test for COVID-19 authorized by FDA

Becton Dickinson launches portable, rapid point-of-care antigen test to detect SARS-CoV-2 in 15 minutes, dramatically expanding access to COVID-19 testing.
  • Co is leveraging its global manufacturing network and scale and expects to increase capacity to be able to produce 2 million tests per week by the end of September. The company already expects to produce up to 10 million tests from July through September. This is the company's third diagnostic test to receive Emergency Use Authorization by U.S. FDA for detecting COVID-19 . 

Becton Dickinson's test can be used on its existing BD Veritor System platform, which is employed in about 25,000 healthcare facilities across the United States.

Antigen tests are a relatively new type of test for COVID-19 that work by scanning for proteins that can be found on or inside a virus.

The authorization was based on a robust sample size of 226 specimens from sites across the United States, Evercore ISI analyst Vijay Kumar said in a research note.

"We think the new antigen test will play a big role in the coming flu season as a rapid, rule out test," Kumar said.

The FDA has touted the rapid tests as an important tool for combating the pandemic because they can be produced quickly, at relatively low costs, and test patients in a variety of settings.

The regulator in May approved the first COVID-19 antibody test, which is made by Quidel Corp.

Wednesday, July 1, 2020

-=T2 Biosystems (TTOO) announces US launch of molecular diagnostic test for COVID-19

T2 Biosystems announces US launch of molecular diagnostic test for COVID-19
  • T2 Biosystems today announced the completion of validation of its COVID-19 molecular diagnostic test, the T2SARS-CoV-2 Panel. The test was developed by T2 Biosystems under a license agreement with the Center of Discovery and Innovation at Hackensack Meridian Health and is being commercially distributed after validation meeting requirements for an Emergency Use Authorization request to FDA.
  • The T2SARS-CoV-2 Panel, designed to detect SARS-CoV-2, provides sample-to-answer results in less than two hours, utilizing a nasopharyngeal swab sample. Clinical testing on known positive and negative patient samples showed a sensitivity of 95% and specificity of 100%. The T2SARS-CoV-2 Panel runs on the company's FDA-cleared T2Dx Instrument.

  • Tuesday, June 30, 2020

    -=Genworth Financial (GNW) sinks on further delay in closing of China Oceanwide transaction

    • GNW and Oceanwide have agreed to a fifteenth waiver and agreement of each party's right to terminate their pending merger agreement, extending the previous deadline of June 30 to no later than September 30. Co "continue[s] to believe the transaction represents the best and most certain value for [co's] shareholders." The transaction has now been moving toward closing for circa 3.5 years. Co indicated that given this latest delay, co is taking steps to address its near-term liabilities; steps are expected to include a debt offering and working toward launching a 19.9% IPO of its US Mortgage Insurance business, in the event the China Oceanwide transaction is terminated. The companies also agreed to additional interim milestones upon which co's right to terminate the merger as of August 31 may be contingent. At multi-year lows.

    Friday, June 26, 2020

    -=Luckin Coffee (LK) withdraws request for Nasdaq hearing; shares to be suspended on June 29

    • Luckin Coffee Inc (LK) said on Friday its shares would be suspended from trading on the Nasdaq from next week as it withdrew a request for a hearing with the U.S. stock exchange on the delisting notice.
    • The Nasdaq’s (NDAQ) reasons for delisting include public concerns raised by the fabricated transactions, company’s failure to disclose material information and to file its annual report.

    Luckin Coffee withdraws request for Nasdaq hearing; shares to be suspended on June 29
  • As previously disclosed, the company received two written notices from the Listing Qualifications Staff of the Nasdaq Stock Market, indicating the grounds of its decision to delist the company's securities from Nasdaq.
  • On May 22, the company requested an oral hearing before the Nasdaq Hearings Panel pursuant to Market Place Rule 4820. On May 23, Nasdaq informed the company of the scheduled hearing date of June 25, 2020.
  • On June 24, the company notified the Listing Qualifications Staff of the company's decision to withdraw its request for the aforementioned hearing and not to seek to reverse or stay the Listing Qualification Staff's determination of delisting the company from the Nasdaq Global Select Market. As a result, the Office of General Counsel of Nasdaq has notified the company that the company's shares will be suspended at the open of business on June 29, and Nasdaq will file a Form 25 Notification of Delisting when all appeal periods have expired.

  • Thursday, June 25, 2020

    -=Accenture Plc (ACN) reported earnings on Thur 25 June 20 (b/o)

    Accenture beats by $0.06, reports revs in-line; guides Q4 revs in-line; guides FY20 EPS in-line
  • Reports Q3 (May) earnings of $1.90 per share, $0.06 better than the S&P Capital IQ Consensus of $1.84; revenues fell 1.0% year/year to $10.99 bln vs the $10.89 bln S&P Capital IQ Consensus.
  • Co issues in-line guidance for Q4, sees Q4 revs of $10.6-11.0 bln vs. $10.92 bln S&P Capital IQ Consensus.
  • Co issues in-line guidance for FY20, sees EPS of $7.57-7.70 vs. $7.58 S&P Capital IQ Consensus, up from $7.48-7.70 previously
  • Co is also raising its range for FY20 free cash flow to $5.8-6.3 bln from $5.5-6.0 bln