News: Press Releases

PointCare Technologies featured in Worcester Telegram and Gazette

June 19, 2007

Lifesaving Tests — Device Helps Third World Fight AIDS
As reported by The Worcester Telegram and Gazette

By Lisa Eckelbecker TELEGRAM & GAZETTE STAFF

MARLBORO— When Petra B. Krauledat and husband W. Peter Hansen, fresh from selling a scientific equipment company, pondered whether to jump back into business with a venture aimed at developing affordable blood-testing equipment for HIV patients in poor countries, they paused.

Then they packed their bags and set out for a three-month trip through sub-Saharan Africa, where they talked to medical workers and patients about the need for a better way to analyze blood for the crucial immune-system cells that signal when a patient needs to begin taking anti-retroviral medicines.

They saw unused high-tech equipment donated by well-meaning westerners and clinics that lacked technicians to use the machines, Ms. Krauledat said, and concluded that a test for patients “at the end of the footpath” would need more than a low price tag.

“No matter how cheap, it was not a matter of money,” said Ms. Krauledat.

The couple returned to Massachusetts and founded PointCare Technologies Inc., which has installed 65 small blood-testing machines in developing countries and recently won a $198,300 grant from the World Bank to place its machines in Malawi. The privately held company, which has raised $5.9 million in angel capital and employs 25 people, is also developing a larger version of its equipment for hospitals and hopes to become profitable later this year or early in 2008.

The U.S. government estimates that about 40 million people worldwide are HIV-positive, but many live in poor countries in Africa and Asia. PointCare’s AuRICA machines are smaller, less costly, battery-operated versions of traditional flow cytometry instruments, bulky diagnostic machines that can cost $100,000.

Competition to create smaller, cheaper, tougher flow cytometry machines for poor countries has attracted both businesses and academic researchers, and it has generated controversy around what constitutes “affordability.”

PointCare officials say their machine sells for $24,500 and each test costs about $10 after adding in the vials, reagents, labels and other materials, which is comparable to the cost of traditional flow cytometry. Ms. Krauledat said the company has found that aid money exists to buy machines and costs per test might come down over time as testing volumes ramp up.

“We deliver a complete result for $10,” she said. “The customer doesn’t have to buy anything. You get everything you need to get a result.”

Researchers at Harvard University and University of Texas at Austin were awarded $1.1 million from the Bill and Melinda Gates Foundation in 2004 for the development of machines that test tiny amounts of blood loaded onto a chip. Former President Bill Clinton’s foundation last year signed a deal with privately held Guava Technologies Inc. to make Guava’s smaller CD4 counting machines available in Africa at a discount.

A group at Purdue University is working on a stripped-down instrument that would count only CD4 cells and rely on gravity to move certain parts.

“We have to have a very cheap, small, robust machine,” said J. Paul Robinson, professor and director of Purdue’s cytometry laboratories, who is aiming for a $5,000 machine that would perform analyses for about 25 cents to 50 cents a test. “Our machine is very unique because it does CD4s and nothing else. It is a minimalist technology. Very few things in it to break. We are not trying to give people every conceivable test.”

Yet microfluidics, or lab tests on chips, has traditionally been costly and some researchers are overly optimistic about finding a way to commercially produce low-cost machines, said Dr. Howard M. Shapiro, a cytometry consultant and author of “Practical Flow Cytometry.” In addition, he said, there is no consensus on what would work best in isolated areas.

The PointCare system “is much simpler than what you put in a centralized lab,” Dr. Shapiro said. “But it is somewhat more complex than what we would envision as the simplest possible machine. The problem is, you go out into the field, you get many different opinions.”

Flow cytometry is a technique used to count cells in a fluid, and it is used in AIDS medicine to analyze samples of patients’ blood for CD4 immune cells. HIV destroys CD4 cells, and doctors monitor patients’ CD4 levels to determine when to start drug therapies.

Traditional flow cytometry for CD4 analysis works by mixing a sample of blood with chemicals known as reagents. Antibodies carrying fluorescent tags latch onto CD4 cells in the blood. The mixture flows past a laser, and a detector counts the CD4 cells.

PointCare’s machine, about as big as a home bread maker and approved by the Food and Drug Administration, uses gold nanoparticles instead of fluorescent tags. Mr. Hansen said using gold eliminates the need for reagents that could quickly wilt in Africa’s heat and sunlight.

“The gold reagent, it allows us to get over the temperature-sensitivity issue, and it reduces the complexity of the flow cytometry,” Mr. Hansen said.

The AuRICA process starts when a technician loads a capped vial of blood and two vials of chemicals into a drawer in the machine. The machine plunges a needle into the three vials, mixes the contents in another vial and passes the mixture in front of a tiny laser.

PointCare’s software then crunches data on light scattered by the sample to come up with the number and percentage of CD4 cells in the sample. AuRICA machines, powered by a car battery, can also count other cells in the sample. A small, inkless printer, which uses paper rolls like those used in cash registers, prints out results. Bar codes on vials provide identification, and technicians never have to open the vials of patients’ blood.

“Not taking the cap off the blood is a very big deal, because this is very dangerous blood,” Ms. Krauledat said.

Ms. Krauledat and Mr. Hansen already have experience launching a scientific instrument, although not one aimed at poor countries. The couple formed and then sold Union Biometrica Inc., a company that developed a drug-screening instrument, to Harvard BioScience Inc. of Holliston.

“We really are thinking about all the people that don’t have access to Boston (style) medicine,” Ms. Krauledat said.