Women Executives Group Opens Doors To Middle Managers
Qualigen Inc. won its first governmental approval for a blood testing system that monitors the risk of prostate cancer.
The Carlsbad-based biotech start-up said July 11 it received Food and Drug Administration approval to bring its “FastPack System” , a test that detects total prostate specific antigen (Total PSA) , into doctor’s offices.
Continuous monitoring of PSA levels in patients who had their prostate removed or had surgery is important to diagnose recurrent cancer early, said Dorothy Deinzer, Qualigen’s director of quality assurance.
Michael Poirier, chairman and CEO of Qualigen, is optimistic doctors will receive the instrument favorably given its speed, small size, accuracy and user-friendliness.
The test allows doctors to take a sample of the patient’s blood, put it in a pouch for chemical testing, and place it into the machine for reading.
Test results are imprinted onto the pouch in less than 15 minutes, Poirier said.
Conventional testing requires patients to wait for laboratory results from a hospital or doctor’s office.
Qualigen’s system allows doctors to test in-house and thus generate testing fees that would otherwise go to outside labs, Poirier said.
He estimated private insurance will reimburse doctors between $35 and $50 per test; Medicare reimbursement will be $26 per test.
At $11,000 for the instrument and $9 per test, the Qualigen system is also less costly than other laboratory machines, which run between $50,000 and $500,000, Poirier said.
FastPack will be the first machine allowing private doctors to test for total PSA in-house, he said. Some 4,000 experimental tests comparing Qualigen’s system to lab testing in three doctors’ offices in the United States and two doctors’ offices in Europe have shown comparable results. FastPack was also twice as sensitive in its ability to detect minute amounts of total PSA than the leading laboratory system, he added.
“That is important for the detection of recurrent prostate cancer,” Poirier said.
The product will be sold by distributors in Europe starting mid-August and in the United States in October.
So far, five orders have been placed for distribution in Europe, Canada and the United States, Poirier said.
Qualigen signed an exclusive agreement with a major U.S. medical device firm.
He cited confidentiality issues that prevented him from offering details.
Poirier said, however, the agreement will boost Qualigen’s revenues significantly.
He projected annual revenues of more than $120 million by 2005.
He also predicted $3 million in annual revenues for the fiscal year ending March 31, 2001, and $20 million for fiscal 2002.
The annual market potential for blood testing is $1.9 billion, according to Qualigen.
Poirier hopes to gain FDA approval for 25 additional blood tests using the same instrument. They will test for various types of cancer, organ disorders and infectious disease.
By year-end, Qualigen will submit applications for two blood tests , one test to detect free prostate specific antigen (Free PSA) and another a prostate-related test on testosterone.
Doctors use the Free PSA test to detect cancer and differentiate cancer from non-cancerous disease, Deinzer said. The Free PSA test helps avoid unnecessary biopsies, she added
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Athena Expands Membership: Athena/UCSD Connect, an organization for senior women executives working in San Diego’s high-tech and life sciences industries, is taking a low-key approach to new memberships.
Athena recently announced it will open its doors to women working in middle management.
Martha Dennis, president of Athena, who is also president and CEO of WaveWare Communications Inc., said the time has come to help women move up the corporate ladder, not just offer ways for top executives to become better leaders.
Women wanting to join the 175-member organization must be sponsored by a current Athena member, and work in middle management and for a UCSD Connect member company.
Send items for inclusion in the biotech column to mwebb@sdbj.com.
