Calypte Only Company with Full Menu of Tests.

"Nobody is criticizing the city, because they've been very proactive on this," said Dr. Frederick P. Siegal, medical director of the H.I.V. center at St. Vincent's Hospital Manhattan in Greenwich Village. "We just think there's an even better direction we'd like to try, or a combination of directions."

Dr. Fred Valentine, director of the AIDS research center at New York University, who is also pushing the city to switch, said, "In the best of all worlds, you'd test everybody both ways," but that would require pouring much more money into testing.

Since the 1980's, standard testing for H.I.V., the human immunodeficiency virus, has meant drawing a vial of blood and using it to perform two types of laboratory tests. Typically, the subject is asked to return a week later for an answer, and that has been a serious problem.

"Overall, in the United States, in public testing sites, 32 percent of the people who test positive don't come back for their results," said Dr. Bernard M. Branson, of the Divisions of H.I.V./AIDS Prevention at the federal Centers for Disease Control and Prevention.

In 2002, a test became available that can produce initial results in as little as 20 minutes, using just a drop of blood, and last year, federal regulators approved a rapid test that uses an oral swab. People who test positive are still advised to have a conventional blood test for confirmation.

A number of state and local governments have adopted rapid testing, none more enthusiastically than New York City. The city has made rapid tests the standard in its sexually transmitted disease clinics, which will perform about 50,000 of them this year, and it has begun using them in its jails, said Dr. Scott Kellerman, assistant health commissioner for H.I.V. programs.

But rapid testing, like traditional blood tests, cannot detect the first phase of H.I.V. infection. Those tests do not look for the virus itself but rather for antibodies that the immune system makes to fight the infection. It takes time for the body to produce enough antibodies to be detectable.

Dr. Branson and other researchers say the newest, most sensitive tests, like those used by New York City, usually find antibodies within three to four weeks of infection, though some experts caution that an estimate of a month or more might be more realistic. But most government and private labs across the country still use older antibody tests that take longer to detect infection.

In the first weeks after infection, the virus multiplies at an astonishing rate, until the body builds up its defenses. Scientists say that on average, there are 1,000 times as many copies of H.I.V. in the blood during that phase as there are several months later.

"These are the most important people to find, because they have the highest viral load, which means they are most infectious, and these people are recently infected, which means they're an active part of the high-risk sexual network," said Dr. Jeffrey D. Klausner, director of sexually transmitted disease programs for San Francisco.

Some experts say that people in the first few months of infection may account for 40 percent to 50 percent of the new infections in others, but such high estimates are disputed.

A partial solution is to test for the RNA of the virus itself, which can be detected within 10 days of infection. Blood banks have done this for a decade.

The RNA test is expensive, so instead of a test on each blood sample, the samples are combined into pools of 10 to 100. Most pools test negative, meaning that all the samples in the pool are negative. If a pool tests positive, it is broken down into smaller groups and retested until the infected sample is found. Like conventional antibody testing, RNA testing takes several days.

North Carolina adopted this technique in 2003 for all publicly financed testing. San Francisco also made RNA testing standard in its sexually transmitted disease clinic in 2003, but it uses rapid antibody tests in other settings. No other public health agencies in the United States routinely use RNA testing, H.I.V. experts say.

In North Carolina, 4 percent of the infections found by RNA tests are not detected by antibody tests, said Dr. Christopher D. Pilcher, director of the testing program run by the state and the University of North Carolina. In San Francisco, Dr. Klausner said, the figure is 10 percent.

The problem of people not learning their test results is a fairly minor one in North Carolina, Dr. Pilcher said, so the state can afford to use tests that do not produce immediate results. Unlike states like New York, North Carolina does not guarantee anonymity in H.I.V. testing; the state knows the identity of each subject, and it tracks down those who do not return for their results.

Dr. Kellerman said New York City was interested in trying RNA testing in the future. But for now, he said, it probably does not make sense for the city.

The cost of RNA testing in North Carolina has worked out to $3.63 per person tested, Dr. Pilcher said. But in San Francisco, where more tests are needed because there are more H.I.V.-positive results, RNA testing costs around $30 per person, Dr. Klausner said.

New York City would likely fall somewhere in between, with a cost for RNA testing comparable to the cost of rapid antibody testing, about $10 per person.

   * Copyright 2005 The New York Times Company





Never argue with an idiot -- they drag you down to their level, then beat you with experience.

External validation trials of the Calypte blood, oral fluid and blood rapid HIV antibody assays began in April 2004 at the Thai Red Cross Anonymous HIV Clinic in Bangkok, Thailand. This study was completed in June 2004 and results have been provided to delegates of the XV International AIDS Conference currently in progress in Bangkok. This study tested a total of 1023 subjects, 392 seropositive subjects, including 37 seropositive subjects receiving anti-retroviral therapy, and 631 seronegative subjects. The true antibody status of these subjects was determined by testing of a blood sample using the standard testing method routinely used by the Anonymous Clinic for diagnostic testing. The Calypte blood rapid test was 100% concordant with the results of the standard blood tests. The Calypte oral fluid test demonstrated 99.5% sensitivity (390/392). The two false negative results were from two known positive subjects who were on anti-retroviral therapy. These patients are known to have diminished antibody levels and would not normally be seeking HIV diagnostic testing. The specificity of the oral fluid test was 100%. The Calypte urine assay was found to be 99.0% sensitive (388/392), 100% specific. The blood, oral fluid, and urine tests correctly identified 1023/1023, 1021/1023, and 1019/1023 for an overall accuracy of 100%, 99.8%, and 99.6%, respectively.

"We are having a successful meeting at the XV International AIDS Conference in Bangkok, Thailand this week, presenting the results of our field trials of our Thailand studies covering over 1,000 subjects," said Dr. Richard George, Calypte's President and Chief Executive Officer. "I am very pleased with the performance of these assays in their initial field testing. The performance of the blood rapid test is on a par with the best laboratory and rapid HIV antibody tests currently on the market. The Calypte assays that test non-invasive alternative fluids showed performance comparable to or better than other such assays currently available. Even though we have other validation studies either in progress or pending and we continue to improve these assays, this study validates our decision to begin manufacturing and commercialization of these assays for the international market. We believe the availability of these safe, accurate, and economical assays will increase the acceptance of HIV testing and will lead to more people knowing their HIV status and being enrolled in treatment programs."

Where we were in 2004...
by: sowerharvest


"Since then we have firmly and diligently addressed these critical elements by validating the technology in three independent clinical trials involving almost 3,000 subjects. Acquiring all the necessary IP licenses and firmly entering the regulatory process in China and in Africa. On the other end of our line of the Legacy Line of products were FDA approved and established in the market place. Our EIA and Western Blot Product lines are strong diagnostic tools with reliable customers that focus on a distinct opportunity in the HIV market. However, going forward we see considerable near term international growth opportunities in the Rapid HIV and BED Incidence Testing markets. Our decision to restructure is in keeping with our objective to distribute our resources toward our future - the Rapid HIV Testing Platform and the BED Incidence Test. As a Company that is spending heavily on Intellectual Property, on regulatory pursuits, manufacturing facilities and product launches I need to focus our resources on what we believe to be the greatest opportunity – our Rapid Test. To this end we have entered into a contract manufacturing agreement with Maxim Biomedical and we currently are expected to conclude a definitive agreement to complete the sale of our Legacy business. In addition to the Rockville restructuring later this summer we also plan to close the administrative offices located in Pleasanton, California and re-locate those activities to Lake Oswego, Oregon. Lake Oswego is a suburb of Portland. This location was selected to consolidate all of our US activities into one location. Our main R&D location was already in this area. When I came to Calypte we operating manufacturing facilities in California and Maryland; R&D was located in Maryland and Vancouver Washington. It was extremely expensive and very difficult to efficiently oversee these scattered operations. Whilst the restructuring is completed our US operation will be reduced to approximately 15 to 20 people located in the same city. And our burn rate will be reduced from $1,100,000 per month level of 2004 to approximately $500,000 per month. I anticipate staffing the US to remain at this level for the foreseeable future and anticipate near term personnel and expenditure growth to come out our Beijing, China site. This restructuring will clear the decks to permit the Company to focus its attention and resources on what we believe to be the future of the Company. Sixteen months after my appointment as CEO Calypte is a much different Company. We have completed the development of three important new Rapid HIV 1-2 assays. One for use with urine samples, one for use with oral fluid samples and one for use with blood samples; these assays have been fully validated. We have acquired all the licenses required to sell these products world wide. We have established manufacturing in Thailand. For the past six months Calypte has been conducting clinical studies in several countries in pursuit of regulatory clearances. We are also please to announce the receipt of the first letter from Uganda clearing the way for sales of Aware® HIV 1-2 Rapid Test for use with blood, oral fluid and urine. Our progress this reporting period has been remarkable. We are a very different Company from what we were in January of 2004. We have streamlined our operations, dramatically cut our costs and we are focused on those activities that will create revenue and move the Company forward. All of us here at Calypte look forward to the rest of 2005. Now I’d like to open this up for questions so operator, please go ahead."
"Since I became President, CEO in January of 2004 I have been diligently rebuilding the Company and trying to focus our attention and resources on the least resistant path to revenue and profitability through our current product line. In evaluating this path it became clear that each product line the Company possesses had its own set of challenges. In January of 2004 the Rapid Test had great promise but very little clinical data. No large scale or repetitive scientific validation, incomplete and restrictive IP issues and no regulatory strategy."


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C.O

Time & Sales  
Price Size Time
0.20 1000 15:35:47
0.20 1000 15:32:08
0.21 100 15:05:41
0.20 300 15:04:36
0.21 300 15:02:58
0.21 10000 15:02:14
0.20 5000 14:55:56
0.21 1000 14:46:29
0.21 11000 14:12:42
0.21 4800 13:37:29
0.21 900 13:34:08
0.21 700 13:34:04
0.21 100 13:33:55
0.21 7000 12:57:05
0.21 600 12:49:24
0.21 7500 12:47:05
0.21 11000 12:46:48
0.21 25000 11:53:51
0.21 1500 11:21:59
0.21 6000 11:17:36
0.21 1000 11:15:39
0.22 400 11:06:46
0.21 10000 10:33:02
0.21 5000 10:20:16
0.21 1000 10:19:28
0.21 500 10:16:32
0.22 3000 10:16:16
0.21 11500 09:48:39
0.21 500 09:48:38
0.21 1400 09:46:49