Biomedex Inc., the upstart Spokane biotech company that will be among the first tenants in a new technology park on the West Plains, says it plans to take to market soon a new product that it envisions will sweep the country, fueled by consumer concern about mercury poisoning.
The product, developed by a Pullman, Wash., dentist in collaboration with a university research scientist there, is intended to provide dentists with a fast, inexpensive way to determine the level of mercury in their patients saliva.
Some research suggests that silver amalgam dental fillingswhich consist of roughly 50 percent mercurycan leach the toxic metal into the mouth, where it can be swallowed. Its unknown so far whether such leaching can cause health problems, but that risk has been getting increased attention in recent years and is the subject of a recent lawsuit filed against the American Dental Association by anti-amalgam groups.
Biomedex announced late last week that it and Todays Technologies, a Pullman concern headed by dentist Alfred Fairbanks, had signed a letter of intent calling for Biomedex to receive exclusive rights to manufacture and distribute the product, called the Oral Mercury Test. Todays Technologies has been working to develop the product in collaboration with Dr. Moris Silber, a Washington State University scientist and medical doctor who owns patents on the chemical solution. Silber worked on the project outside his role at WSU.
Biomedex, a contract manufacturing and consulting company that primarily serves the biopharmaceutical industry, also has exclusive manufacturing and distribution rights to a testing device used by allergists. The Spokane company currently employs 25 people and expects to have sales this year of about $3 million.
Company President George Coleman says the main component of the mercury test, a chemical solution, initially will be manufactured in a biotech lab at the Spokane Intercollegiate Research and Technology Institute, where Biomedex currently is housed. Biomedex also will distribute a device called a colorimeter, which is required for the test. A Dayton, N.J.-based manufacturer called United Products & Instruments Inc. will produce the custom-designed colorimeters that will be sold to dentists for use with the test.
The test will be administered in a dental office, and will require a patient to chew gum for a few minutes and then spit into a collection cup. A measured amount of the patients saliva then will be mixed with the chemical solution and that mixture will be read by the colorimeter, which instantly will determine the amount of mercury present in the patients saliva. The entire test is expected to take between five and seven minutes.
Using the results of the test, the patient and dentist then can discuss possible health risks and whether further testing or action, such as replacing silver amalgam fillings with another material, might be merited.
Silber and Fairbanks completed their work on the testing product late last year. A Spokane-based business consultant named Christopher Wood, of Ten X Strategies LLC, then introduced Todays Technologies, which is one of his clients, to Biomedex as a possible partner for commercializing the product.
I knew the first time we sat down with Dr. Fairbanks that things just felt right, says Coleman. They wanted to keep as much business in the region as possible, which is what Biomedex has been about since our inception. Their need for technical, controlled formulation and filling was a perfect fit.
Coleman says the next step will be for Biomedex to set up and test manufacturing of the product at SIRTI, a process that will take about 60 days to complete. He says he hopes to begin manufacturing and selling the solution by November or December.
Initially, enough solution for about 100 tests will be packaged together with the custom-made colorimeter and other testing supplies, and sold directly to dentists, who then will be able to buy additional packages of the testing solution and supplies from Biomedex as needed. No information is available yet on how much Biomedex will charge for the testing kits. Its also not yet known how much dentists would charge patients for conducting such a test, but that cost is expected to be low, perhaps $20 to $30.
Biomedex officials believe the test will be the first of its kind. Currently, testing for mercury isnt typically available in a dentists office, and would require that saliva or another bodily fluid be sent to an outside lab for testing, they say.
Coleman wont speculate on how much of the solution Biomedex might be able to sell, but says that the Spokane company expects its annual sales to more than triple next year to more than $9.6 million, and that the oral mercury test will be a significant reason for that projected increase. Biomedex likely will need an additional five to 10 employees to support the new product, he says.
This could be a very big deal, says Coleman.
To be successful, however, the company will have to convince dentists that there will be increasing market demand from consumers to learn if they are swallowing traces of mercury from their dental fillings, whether or not there is evidence yet that such leaching is harmful.
Mercury is a toxic metal that can cause immune, sensory, neurological, motor, and behavioral dysfunctions. Environmental and consumer-rights groups have called for bans on its use in thermometers and other products. A coalition of such groups and some dental patients filed suit June 12 against the ADA and the California Dental Association, claiming that the two organizations have misled the public about alleged dangers of mercury in amalgam fillings.
The ADA, however, has responded publicly that the suit is without merit and that dental amalgams have been used safely for more than 150 years.
Biomedex, formed in 1999 by a group of former executives of Bayer Corp. here, expects to break ground within weeks on a $15 million, 60,000-square-foot biotech plant in the planned Pacific Northwest Technology Park, which is to be located just east of the Boeing Co. plant on U.S. 2 near Airway Heights. The plant is expected eventually to employ about 120 people. Work on other structures there, including an office building, hotel, bank, restaurant, and day care, already is under way or planned to start soon.
Second plant eyed
With groundbreaking on its first biotech plant still a few weeks away, Biomedex Inc. says it already is talking with an international construction concern about the possibility of building a second one.
Also, the young Spokane biotech company says it has agreed to buy enough land in the planned West Plains technology park where it will be based to add a third building there in the future.
Biomedex President George Coleman declines to name the construction company that hes in discussions with, but says that company would build and own the building on the land Biomedex plans to buy in the park, which is to be located just east of the Boeing Co. plant on U.S. 2 near Airway Heights.
The planned 224-acre park, called the Pacific Northwest Technology Park, is being developed by Granite Investments LLC, which is headed by prominent Spokane developer Dick Vandervert. Granite expects to begin work soon on Biomedexs first plant, a 60,000-square-foot, $15 million building, and initially will lease it to Biomedex. Granite also has started work there or expects soon to start work on a $12.5 million, 110,000-square foot office building; a $10 million, 120-room Hilton Gardens hotel, a Bank of Whitman branch; a restaurant; and a 9,000-square-foot day-care facility. The park, which is situated just north of Spokane International Airport, is envisioned eventually to have perhaps dozens of buildings.
Coleman says the possible second Biomedex plant would have about 25,000 square feet of floor space and would be used for whats called mammalian cell cultures, a process in which proteins are manufactured for pharmaceutical products. He says construction of the facility could begin next year if the parties decide to go ahead.
Biomedex would use the plant to perform pilot-scale and scale-up production to big pharmaceutical companies. Pilot-scale refers to the amount of product needed to perform clinical trials as a pharmaceutical company is seeking U.S. Food and Drug Administration approval of a drug. Once FDA approval is received, such companies often need a temporary location to begin producing their new product for market while their own, bigger facilities are built or made ready for high-volume production, Coleman says. He says there is great demand for those services, and that Biomedex has the expertise to do well in that market.
The companys plan to buy its own land in the park from Granite Investments will give it the flexibility later to expand to a third building, as demand for such contract manufacturing grows, Coleman says. Biomedex also hopes to buy its first plant there from Granite. The company expects to have a continued presence in the Spokane Intercollegiate Research and Technology Institute near downtown, where it has been housed since its inception in 1999.
Subscribe today to our free E-Newsletters!SUBSCRIBE