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Big Sorrento Valley cash to be had from Zika

San Diego biotech unit gets emergency FDA permission to test virus diagnostic kits

Zika carrier Aedes aegypti during blood meal
Zika carrier Aedes aegypti during blood meal

The number of San Diego Zika virus infections continues its relentless growth, bringing the county to within one case of California Zika count leader Los Angeles, but at least one local big-money biotech outfit is looking to prosper from the worldwide breakout.

As of July 29, according to the latest report from the California Department of Public Health, San Diego has registered 23 infections, including one non-resident; L.A. has posted 24 cases.

Two weeks earlier, on July 15, Los Angeles was California's number-one Zika county by a wider margin, with 22 cases, while San Diego reported a total of 16. All of the 114 cases reported statewide so far in 2015 and 2016, including San Diego's, are travel-associated, according to state health officials.

San Diego's first Zika case was determined to be sexually transmitted this past February. "A San Diego man was visiting Colombia where he sustained some mosquito bites in January," according to a March 25 advisory from the county health department.

"Four days before his return to the county in early February, he had the onset of subjective fever, arthralgia, and maculopapular rash. Upon arrival in San Diego, he was still symptomatic with rash and arthralgia and he had unprotected sexual contact with a non-pregnant woman who had no travel outside the county."

The notice continued, "Seven days after initial sexual contact with the man, the woman developed fever to 101° F and a blanching, salmon to red colored, maculopapular rash on her trunk. The rash spread to her neck and extremities over the next two days and she developed arthralgia in her hands and feet."

The woman was subsequently determined to be infected with Zika, according to the federal Centers for Disease Control, and mosquito transmission was ruled out.

"Neither patient reported mosquito bites in San Diego and no Aedes species mosquitoes were detected in traps set by the San Diego County Vector Control Program around the residences of either patient," said the report.

Meanwhile, the onetime San Diego biotech start-up formerly known as Gen-Probe is looking to make hay with an experimental clinical test for the virus, which causes birth defects in babies of infected mothers.

Bought by Hologic, Inc. for $3.8 billion in cash back in 2012, the unit, still based in San Diego's Sorrento Valley on Genetic Center Drive, was issued an emergency-use authorization last month for its "Aptima® Zika Virus assay for the qualitative detection of RNA from Zika virus in human serum and plasma specimens," according to a June 17 letter to the firm from federal Food and Drug Administration commissioner of food and drugs Robert M. Califf.

"There is no adequate, approved, and available alternative to the emergency use of the Aptima® Zika Virus assay for detecting Zika virus and diagnosing Zika virus infection," according to the letter, which adds, "Hologic, Inc. will report to FDA any suspected occurrence of false positive and false negative results and significant deviations from the established performance characteristics of the test of which Hologic, Inc. becomes aware."

Adds the document, The known and potential benefits of the Aptima® Zika Virus assay for detecting Zika virus and diagnosing Zika virus infection outweigh the known and potential risks of such product.”

Four South Florida Zika cases found last week to be due to mosquito bites have ratcheted up the political pressure in Washington to provide more federal cash to combat the virus, ultimately translating to a potential windfall for Hologic.

But the news in San Diego is not all good for the company. In February of this year, Karmen Smiley, a former Genprobe accountant, sued Hologic in California superior court here, alleging she was harassed and let go after calling attention to illegal accounting practices by the firm last year, according to MassDevice.

“During her entire time working for Gen-Probe, and for the first few years working for Hologic, Ms. Smiley was never disciplined. In fact, she received numerous performance awards during her tenure. As recently as 2014, Ms. Smiley received a performance review stating she consistently meets and occasionally exceeds expectations,” the complaint said.

Hologic has denied the allegations, and the case has been moved to federal court, where it remains under litigation.

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Zika carrier Aedes aegypti during blood meal
Zika carrier Aedes aegypti during blood meal

The number of San Diego Zika virus infections continues its relentless growth, bringing the county to within one case of California Zika count leader Los Angeles, but at least one local big-money biotech outfit is looking to prosper from the worldwide breakout.

As of July 29, according to the latest report from the California Department of Public Health, San Diego has registered 23 infections, including one non-resident; L.A. has posted 24 cases.

Two weeks earlier, on July 15, Los Angeles was California's number-one Zika county by a wider margin, with 22 cases, while San Diego reported a total of 16. All of the 114 cases reported statewide so far in 2015 and 2016, including San Diego's, are travel-associated, according to state health officials.

San Diego's first Zika case was determined to be sexually transmitted this past February. "A San Diego man was visiting Colombia where he sustained some mosquito bites in January," according to a March 25 advisory from the county health department.

"Four days before his return to the county in early February, he had the onset of subjective fever, arthralgia, and maculopapular rash. Upon arrival in San Diego, he was still symptomatic with rash and arthralgia and he had unprotected sexual contact with a non-pregnant woman who had no travel outside the county."

The notice continued, "Seven days after initial sexual contact with the man, the woman developed fever to 101° F and a blanching, salmon to red colored, maculopapular rash on her trunk. The rash spread to her neck and extremities over the next two days and she developed arthralgia in her hands and feet."

The woman was subsequently determined to be infected with Zika, according to the federal Centers for Disease Control, and mosquito transmission was ruled out.

"Neither patient reported mosquito bites in San Diego and no Aedes species mosquitoes were detected in traps set by the San Diego County Vector Control Program around the residences of either patient," said the report.

Meanwhile, the onetime San Diego biotech start-up formerly known as Gen-Probe is looking to make hay with an experimental clinical test for the virus, which causes birth defects in babies of infected mothers.

Bought by Hologic, Inc. for $3.8 billion in cash back in 2012, the unit, still based in San Diego's Sorrento Valley on Genetic Center Drive, was issued an emergency-use authorization last month for its "Aptima® Zika Virus assay for the qualitative detection of RNA from Zika virus in human serum and plasma specimens," according to a June 17 letter to the firm from federal Food and Drug Administration commissioner of food and drugs Robert M. Califf.

"There is no adequate, approved, and available alternative to the emergency use of the Aptima® Zika Virus assay for detecting Zika virus and diagnosing Zika virus infection," according to the letter, which adds, "Hologic, Inc. will report to FDA any suspected occurrence of false positive and false negative results and significant deviations from the established performance characteristics of the test of which Hologic, Inc. becomes aware."

Adds the document, The known and potential benefits of the Aptima® Zika Virus assay for detecting Zika virus and diagnosing Zika virus infection outweigh the known and potential risks of such product.”

Four South Florida Zika cases found last week to be due to mosquito bites have ratcheted up the political pressure in Washington to provide more federal cash to combat the virus, ultimately translating to a potential windfall for Hologic.

But the news in San Diego is not all good for the company. In February of this year, Karmen Smiley, a former Genprobe accountant, sued Hologic in California superior court here, alleging she was harassed and let go after calling attention to illegal accounting practices by the firm last year, according to MassDevice.

“During her entire time working for Gen-Probe, and for the first few years working for Hologic, Ms. Smiley was never disciplined. In fact, she received numerous performance awards during her tenure. As recently as 2014, Ms. Smiley received a performance review stating she consistently meets and occasionally exceeds expectations,” the complaint said.

Hologic has denied the allegations, and the case has been moved to federal court, where it remains under litigation.

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