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Cepheid Molecular Diagnostics Company

 Cepheid Molecular Diagnostics Company

Cepheid is an American molecular diagnostics company. Its systems automate traditional nucleic acid testing (testing specific DNA or RNA sequences). These tests can be used to identify and analyze pathogens and genetic diseases. Cepheid markets clinical tests for health-related infections, infectious diseases, sexual health, oncology and genetics. The cartridges used in the Cepheid tester are disposable and must be purchased from the manufacturer. The company has been accused of making money, especially in developing countries, by overcharging ink cartridges and engaging in price discrimination. 

Cepheid is the flagship product, the GeneXpert rapid molecular diagnostic system. The system was developed in the 1990s. The design is largely unchanged from the turn of the century to 2020. Abbott and Roche then developed similar tests.

The GeneXpert system identifies organisms from DNA. It extracts the genetic material from the sample and, in the case of RNA viruses, first converts the RNA into DNA. GeneXpert tests are essentially automated versions of standard real-time PCR (polymerase chain reaction) amplification and detection. 

Each test sample is added to a single-use GeneXpert kit sold by Cepheid. After that the check is independent and fully automatic. The cartridges contain a series of injectable plastic chambers containing chemicals and samples. 

Several cartridges (also made by Cepheid, but reusable) were loaded into the desktop for testing. Microfluidics is used to move the samples and chemicals in the test chamber: in the middle is a rotary valve and some small pistons.

The piston forces the sample into the valve, the valve rotates to a new position, and the sample is drawn into the new chamber. 

The machine provides the necessary temperature cycle for PCR (similar to a programmable oven). This allows many copies of the DNA to match (amplify) the sample. Finally, the presence or absence of pathogens is determined using FISH probes. These are short fragments of DNA bound to fluorescent molecules. 

If the DNA in the sample matches the DNA of the FISH probe, the two will bind and the sample will fluoresce. The optical system determines the gloss or its absence.  

The new disease can be tested by simply changing the FISH probe that matches the sequence of the new disease.



Key technical innovations in GeneXpert technology, as well as early product and field testing, were performed at the University of California, Lawrence Livermore National Laboratory. It is funded by DARPA and the US Army Micro-Electro-Mechanical Systems (MEMS) program, as well as LLNL's internal budget. Founded in 1995, Cepheid was largely funded by the US military until the 2001 anthrax attack.

During the 2001 anthrax attacks, US federal agencies contracted Cepheid to track anthrax. 

In 2003, the company put health care on hold in preparation for a federal deal with defense contractor Northrop Grumman to install anthrax detection systems in U.S. post offices across the country.


For which Tests a GeneXpert cartridge were sold during 2021?

Tests for which a GeneXpert cartridge sold during 2021:


          Respiratory syncytial virus

         Chlamydia and gonorrhea

          Group B streptococcus

          Clostridium difficile

          Trichomonas vaginalis

          Human papillomavirus


          Methicillin-resistant Staphylococcus aureus

          Chronic myeloid leukemia

          Clotting disorders


          Other drug-resistant bacteria


Cepheid's Reagent Bead Dispenser received the 2006 Industrial Design Excellence Award.

The first clinical application of the GeneXpert system was introduced in 2006, when the US FDA approved XpertGBS, a rapid molecular diagnostic test for group B streptococci in pregnant women. That same year, the FDA classified XpertGBS as "moderately complex" under the Clinical Laboratory Improvement Amendments (CLIA). This is the first amplified molecular diagnostic test using real-time PCR to achieve this classification. As a result, more than 27,000 medium-complexity CLIA-registered facilities participate in the test, in addition to approximately 7,000 high-complexity test-registered facilities. 

In 2012, Cepheid won a contract from the US Department of Veterans Affairs for the MRSA test kit.

As of March 31, 2014, Cepheid sold 14 US FDA-approved clinical in vitro diagnostic (IVD) tests and 16 international IVD tests in the US, with 6,012 GeneXpert systems deployed worldwide. The long-term investment in TB testing infrastructure, as of March 2020 there were more than 23,000 GeneXpert machines worldwide, between 7,000 and 10,000 in Africa, Latin America and Southeast Asia, and more than 100 global funds in some African countries, including the others.

During the COVID-19 pandemic, Cepheid announced in February 2020 that it had partnered with Sherlock Biosciences to begin developing a CRISPR-based diagnostic test for the SARS-CoV-2 (then called "2019-nCov") virus to work with own. machine To run Cepheid's 20-year-old GeneXpert test, the hospital installed the machine.

In March 2020, the company announced a rapid diagnostic test for SARS-CoV-2; The US FDA granted emergency use authorization for the test.

The diagnostic is designed to run on all (over 23,000) existing Cepheid GeneXpert machines worldwide with a standard analysis time of 45 minutes. Price conflicts

Pricing for the Cepheid test kit has been controversial.

Cepheid said they will charge $19.80 for a COVID-19 test in developing countries (prices are higher in middle-income countries; for example, the GeneXpert TB test in Indonesia costs $55-$82 per box).

MSF said the cost was prohibitive in a country where people live on less than two dollars a day. They estimated that it cost Cepheid only $3 to provide the tests, and called the proposed prices profit-making, asking Cepheid to sell the tests for $5 for a more modest profit.

The Therapeutic Action Group (TAG) accepted the request, saying that the test's development, procurement and global rollout were done with public funds, while the owner of Cepeid (a Danaher company) made $3 billion in profits in 2019. They called for the same price cut for all tests with the same technology, including HIV, TB and hepatitis C, because the cost is the same regardless of the disease (see above). They noted that in March 2020, the cost of a cartridge to test for COVID-19 was nearly double the cost of a nearly identical TB cartridge. 

The International Alliance against Tuberculosis and Lung Diseases has also provided public support.

Since October 2019, dozens of organizations around the world have joined the Time for $5 campaign.



What is Cepheid  for Laboratory Technician?

Cepheid's comprehensive menu of tests includes the solutions you need, from specialized oncology to other major infectious diseases, virology and healthcare-associated infections. 

They offer you better options and meet your laboratory needs. Consolidating multiple tools and technology platforms into one reduces delivery requirements while increasing operational efficiency. And more internal testing means faster turnaround times and improvements

Clinician satisfaction. platform. Many tests. Now you can deploy up to 28 CE-IVD molecular tests on a single, highly scalable platform that is versatile enough to meet your needs in a variety of healthcare environments. 

Regardless of the time of day or healthcare environment, they are constantly striving to provide practical answers to patients.


What is Cpheid for Emergency Physician?

When emergency physicians like you need answers, you need them now. They design molecular point-of-care systems to deliver the most accurate results when they're needed, helping you stay ahead of urgent, life-threatening patient issues, triage patients faster, and help improve key quality metrics. Managers of alternative places and points of care.


As an alternative site and treatment manager, you work to help deliver better outcomes for patients in the local community. 

They know you need confidence in your test results to increase patient satisfaction, reduce unnecessary antibiotic use, and limit patient readmissions. 

Cepheid delivers accurate results quickly, meaning testing capabilities are available that can be used in any environment with no environmental restrictions and minimal training. 

Specialist in infection control

Infection preventionists like you work tirelessly to help stop infectious agents before they reach other members of your community. 

Cepheid solutions, such as our comprehensive HAI menu, help you take early action against infectious diseases, simplify the use of contact precautions, and improve your facility's quality scores. 

Antimicrobial stewards, pharmacists, microbiologists

Pharmacists, microbiologists and antimicrobial stewards work at the forefront of the fight against antimicrobial resistance. Their on-demand molecular testing solutions help improve antimicrobial stewardship, reduce unnecessary treatment costs, and minimize follow-up by optimizing early treatment, all of which improve patient outcomes.


What is the corporate status of Cpheid?

Cepheid was founded in March 1996 by Thomas Gutschall, Bill McMillan, Drs. Kurt Petersen, Dr. Greg Kovacs, Stephen Young and Dr. Allen Northrup.

The company was launched in 2000. The initial public offering took place on June 21, 2000 at $6 per share.

Cepheid's stock was listed on the Nasdaq under the ticker CPHD until it was acquired by Danaher in 2016.

The company's first CEO was Tom Gutschall, who held this position from 1996 to 2002. In April 2002, John L. Bishop was appointed CEO.

As of August 2016, the company's market capitalization was $2.66 billion. In late 2016, Danaher Corporation acquired Cepheid for $4 billion, citing the large number of test instruments installed and the extensive test menu that matches those instruments. Cepheid is headquartered in Sunnyvale, California.


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