Diagnostics & Imaging Week

Cellestis’ (Valencia, California) efforts to bring its blood test for tuberculosis to the U.S. market have paid off with both reimbursement from the Centers for Medicare & Medicaid Services (CMS; Baltimore) and, as the company reported earlier this month, new guidelines from the Centers for Disease Control and Prevention (CDC; Atlanta) advising that Quantiferon-TB Gold can be used in all circumstances in which the traditional tuberculin skin test is currently used.

Quantiferon-TB Gold is described as “a simple, one-step blood test,” that offers the possibility of detecting TB with greater specificity than has been possible previously.

“We’ve waited a long time for the CDC to come out with the guidelines, but basically they fully recommend this test as an alternative for the skin test,” Mark Boyle, senior vice president of sales and marketing at Cellestis, told Diagnostics & Imaging Week. “That’s where all our efforts of getting the right product to the market, getting the right information to the market, getting the results of various studies [have led to] the CDC looking at it and saying, ‘Yes, we’re ready.’”

The guidelines, published in the CDC’s Dec. 16 Morbidity and Mortality Weekly Report, affirm that Quantiferon-TB Gold can be administered in the place of the standard TB skin test, which dates back to the 1890s.

Boyle told D&IW that the test would begin to be reimbursed by CMS beginning Jan. 1.

“That, again, is obviously going to help,” he said. “That will extend through the various states – through Medicaid, as well, so I mean this is where it really starts to roll out.”

Cellestis is pleased with the fee for laboratories set at $86.59 by CMS, Boyle said, although he noted that there may be somewhat of a “challenge” in persuading laboratories to adopt the blood test, since they have never had one before for TB.

The new test requires a sample of blood, in which T cells are activated that are specific to TB. The test uses synthetic peptides that have been identified as being totally specific to the TB organism.

With the standard skin test that has been used for decades, an antigen is injected under a person’s skin and the patient waits for a reaction, which must be interpreted by a healthcare worker and requires a trip back to the medical office, Cellestis has previously told D&IW. After 48 hours following injection, a bump develops on the skin and the healthcare worker interprets it to determine if there is infection by Mycobacterium tuberculosis. Currently, as many as 30% of people tested with the TST do not return for the required second screening.

The company has said over the past year and a half that the standard test can be unreliable because of false-positive and false-negative results. Typical, and often mandatory, TB tests include contact investigations, evaluation of recent immigrants, and infection control surveillance programs, such as yearly testing for healthcare workers.

Quantiferon-TB Gold is also able to detect latent or non-symptomatic TB in individuals while eliminating candidates who have had BCG vaccinations for TB, a common cause for false-positive readings with the TST. The company has said nearly 700,000 legal immigrants come to live in the U.S. every year, and the U.S. has about 7.1 to 9 million illegal immigrants, most of whom come from countries where TB is common. Not only that, but many of them have been vaccinated for TB, which is likely to result in a false positive result with the traditional skin test.

“One of the greatest problems in combating this disease has been the reliance on an antiquated detection method,” Dr. Tony Radford, managing director of Cellestis in the U.S., said in a statement. “These guidelines represent a significant advancement in the detection and potential elimination of TB in the U.S.”

The Cellestis TB test was approved by the FDA in December of last year.

Cellestis, a public company trading on the Australian Stock Exchange, has offices in Australia and Germany in addition to the U.S. office. The Valencia facility has eight employees, but the company, which will be responsible for all marketing of the product, expects to expand its work force, Boyle said, as its test comes to market. Boyle has said that in marketing the new product, the company will focus on public health programs, hospitals and jails and prisons.

“Quantiferon-TB Gold represents a breakthrough in TB diagnosis and control and offers several important advantages, including the fact that it is more accurate than the TST and only requires one visit,” said David DeBiasi, RN, director of community health and tuberculosis services for the American Lung Association of Virginia (Richmond). “New diagnostics such as Quantiferon-TB Gold are the key to the future success of eliminating TB, which continues to ravage the globe, causing nearly 2 million deaths a year.”

Quantiferon technology was developed by Australian researchers for the detection of TB infection in cattle. The test is now sold and used in more than 30 countries, Cellestis said.