Qualigen’s POL PSA Test Cleared for Sale by FDA

Goal is to introduce in-office PSA testing to urologists in a fall marketing campaign

CEO SUMMARY: Qualigen, Inc. gained FDA approval to sell its FastPack™ System for PSA testing in the United States. Qualigen is one more example of a technology company that expects to shift diagnostic testing out of core laboratories and closer to the patient. Initially Qualigen will sell this system to urologists, where it believes the 15-minute turnaround time for PSA results will make it a winner.

AFTER ONLY FOUR YEARS of development, Qualigen, Inc. gained approval from the Food and Drug Administration (FDA) to sell its FastPack™ System for total PSA testing in the United States.

FastPack is actually a diagnostic instrument platform designed to perform a broad spectrum of quantitative immunoassay testing in a physician’s office laboratory or small lab setting. To establish a foothold in the lab testing marketplace, Qualigen will initially focus on urology tests such as total PSA, free PSA, and testosterone.

Concentrate On Urology

“Our business strategy is to concentrate on meeting the diagnostic testing needs of urologists,” said Nicholas Kuhn, Vice President of Sales and Marketing at Qualigen. “We expect to launch sales early in the fall. Right now we are scaling up manufacturing and finalizing distribution arrangements in the United States.

“We have high expectations for this product,” continued Kuhn. “The instrument was placed in a number of urology offices for evaluation and study. Urologists became very excited when they saw results from PSA tests were available in only 15 minutes!”

According to Kuhn, urologists also recognize the potential to improve specimen integrity. The test can be performed within minutes of the blood draw, minimizing the problems of specimen degradation, lost specimens, and accessioning errors that inevitably affect specimens transported for overnight testing at commercial labs.

Qualigen’s product has some interesting technical features. “Our assay uses plasma, as well as serum,” explained Kuhn. “Literature suggests that free PSA testing done on plasma may yield better results.

“For laboratorians concerned about quality issues, our instrument is designed to maximize the quality and reproducibility of results,” he continued. “For example, the instrument will not accept out-of-date reagents and calibrators. Nor will it run a test if the calibration period has expired.

“As a moderate complexity test, controls must be run daily. The instrument notifies operators when controls are out of range,” Kuhn noted.

Additional Income

List prices for the FastPack instrument and PSA test kits is expected to be $11,300 and $8.50, respectively. Since reimbursement for immunoassay tests are at much higher levels than routine chemistry tests, urologists should be able to generate additional income from in-office PSA testing.

Armed with its FDA approval, Qualigen becomes only the newest market entrant among a growing number of technology companies actively developing near-patient and point-of-care diagnostic products. Qualigen is one more sign in the marketplace that technology is nearing the point when the performance and economics of near-patient testing is at least as competitive as core lab testing.

Laboratory executives and pathologists will find several other intriguing aspects to the Qualigen story. First, it is bringing an immunoassay testing solution to the physician’s office environment. If Qualigen’s FastPack proves a hit with the urology profession, it will eventually divert a sizeable volume of lucrative testing away from commercial laboratories.

Lab Outsourcing Potential

Although it will probably be 24 months before it happens, both DIANON Systems, Inc. and UroCor, Inc. may be first to experience revenue drain from this phenomenon. Both companies do high volumes of PSA testing for urologists nationally. It will be interesting to see if their response will be to embrace in-office PSA test- ing and act as “lab managers” for urologists. Precisely that type of lab outsourcing is predicted by Bruce A. Friedman, M.D. in the newsmaker interview on pages 9-16.

Second, Qualigen’s FastPack will be a market test of whether urologists are willing to accept the responsibility for in-office PSA testing (including issues of test result quality), in exchange for the benefit of presenting the patient with his test results in 15 minutes.

Third, Qualigen’s entry into the clinical marketplace will demonstrate whether near-patient testing technology is ready for “prime time.” If so, the company can be expected to expand the immunoassay tests it offers on its FastPack system, as well as the physician specialties that it wants to convert to in-office testing.

In-Office Testing Benefits

Fourth, companies with point-of-care diagnostics for physician office use will be using arguments that physicians should do in-office testing because it: 1) enhances test result quality due to better quality specimens; 2) creates happier patients from faster test results; and 3) can generate additional income for the physician.

The competitive marketplace will determine whether Qualigen’s in-office testing technology is clinically and economically viable. What THE DARK REPORT considers noteworthy is that Qualigen represents that growing category of diagnostic vendors who are ardently committed to making near-patient and point-of-care testing a viable and sizeable part of the lab testing community.

The success of Cytyc Corporation in converting as much as 20% of the nation’s Pap smear testing to its ThinPrep liquid preparation product in only four years demonstrates that these new POC diagnostic vendors have the potential to cause significant changes in how and where diagnostic testing is performed.

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