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CEMI

Chembio Diagnostics

$5.34

(0.00%)

08:17
11/04/19
11/04
08:17
11/04/19
08:17

Chembio Diagnostics receives WHO Prequalification approval for HIV self-test

Chembio Diagnostics announced its SURE CHECK HIV Self-Test has received World Health Organization Prequalification approval. The WHO Prequalification of In Vitro Diagnostics is a comprehensive assessment of individual IVDs through a standardized process that includes inspection of the manufacturing site, review of a product dossier, performance evaluation including operational characteristics, and labelling review. It signifies that the product meets global standards of quality, safety and performance, and is used by United Nations and other procurement agencies such as PEPFAR, UNITAID, and the Global Fund to make purchasing decisions. The SURE CHECK HIV Self-Test provides unparalleled ease of use -- using the world's smallest blood sample required by any rapid HIV test -- and provides results in 15 minutes. The unique design of the SURE CHECK HIV Self-Test integrates the capillary device and buffer solution, eliminating the need for separate collection devices and buffer solution bottles required by other HIV self-tests. The SURE CHECK HIV Self-Test, which detects antibodies to HIV 1 and HIV 2, demonstrated sensitivity of 99.4% and specificity of 100%, when comparing untrained HIV self-test users to trained professionals. The essential element of Chembio's newly WHO Prequalified HIV Self-Test is the company's SURE CHECK HIV 1/2 Assay that is FDA approved, CLIA waived, CE marked, WHO Prequalified, and trusted by health care professionals across the globe. Chembio's SURE CHECK HIV 1/2 Assay was also incorporated into two CE marked private label versions of HIV self-tests that both commenced European commercialization in 2015. In 2016, the WHO published global HIV self-testing guidelines, recommending that HIV self-testing be offered as an additional approach to HIV testing services. Chembio's SURE CHECK HIV Self-Test was evaluated by the HIV Self-Testing Africa Initiative that is funded by UNITAID, with the goal of accelerating self-test adoption by addressing market, regulatory and policy barriers. SURE CHECK HIV Self-Test was found to have superior acceptability and performance, facilitating widespread adoption.

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CEMI Chembio Diagnostics
$5.34

(0.00%)

12/19/18
DOTC
12/19/18
INITIATION
Target $12
DOTC
Buy
Chembio Diagnostics initiated with a Buy at Dougherty
Dougherty analyst Kyle Bauser initiated Chembio Diagnostics with a Buy and $12 price target.
01/04/19
ADAM
01/04/19
INITIATION
Target $9
ADAM
Buy
Chembio Diagnostics initiated with a Buy at Canaccord
Canaccord analyst Mark Massaro initiated Chembio Diagnostics with a Buy rating as he believes it is an underappreciated player in the very attractive point-of-care diagnostics space. The analyst said Chembio has best-in-class test accuracy and he likes its third party partnerships model. He also believes it can increase U.S. market share and make an even greater impact outside of the United States. Massaro has a $9 price target on Chembio Diagnostics shares.
06/17/19
BNCH
06/17/19
NO CHANGE
Target $9
BNCH
Speculative Buy
Chembio Diagnostics price target lowered to $9 from $14 at Benchmark
Benchmark analyst Bruce Jackson said he is taking a more conservative approach to his 2020 revenue estimates for Chembio Diagnostics and using a more conservative multiple, which lowered his price target on the stock to $9 from $14. Management guidance for 2019 is expected to be backend loaded and he cites the "binary nature" of potential contracts for his more cautious stance. Jackson keeps a Speculative Buy rating on Chembio shares.
07/09/19
BNCH
07/09/19
NO CHANGE
BNCH
Alibaba, Take-Two among Benchmark's Best Ideas for second half
Benchmark's analyst team laid out their Best Ideas for the second half of 2019, naming Alibaba (BABA), Take-Two (TTWO), BioTelemetry (BEAT), Biofrontera (BFRA), Chembio Diagnostics (CEMI), Ctrip (CTRP), Green Thumb Industries (GTBIF), II-VI (IIVI), LivePerson (LPSN), Nanometrics (NANO), Nexstar (NXST), Pegasystems (PEGA), Tabula Rasa HealthCare (TRHC) and Waitr Holdings (WTRH) to their list.

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