FDA broadens the age range of Gardasil 9 to cover individuals 27 through 45 years old

The US Food and Drugs Administration (FDA) extended the use of Merck’s cervical cancer vaccine Gardasil 9 to include men and women aged 27 through 45 years.

"Today's approval represents an important opportunity to help prevent HPV-related diseases and cancers in a broader age range," Peter Marks, MD, Ph.D., director of the FDA's Center for Biologics Evaluation and Research, says in a news release.

"The Centers for Disease Control and Prevention has stated that HPV vaccination prior to becoming infected with the HPV types covered by the vaccine has the potential to prevent more than 90% of these cancers, or 31,200 cases every year, from ever developing," Marks says.

 "The CDC has made increasing HPV vaccination rates a public health priority,” said Jacques Cholat, M.D., president, Merck Vaccines, “and today’s recommendation for GARDASIL 9 is an important milestone in the shared effort to help further reduce the burden of HPV-related cancers and diseases.”

According to CDC, every year about 14 million Americans become infected with HPV; about 12,000 women are diagnosed with, and about 4,000 women die from cervical cancer caused by certain HPV viruses. Additionally, HPV viruses are associated with several other forms of cancer affecting men and women. 

FDA first approved Gardasil in 2006, to prevent certain cancers and diseases caused by HPV Types 6, 11, 16, and 18. Gardasil is no longer available in the US. Gardasil 9 received approval in 2014 for use in girls and women 9 through 26 years of age and boys 9 through 15 years of age for the prevention of the cancers and precancerous lesions of cervix, vulva, vagina, and anus caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58.

The approval is based on results of a study involving 3,200 women, aged 27 through 45 years, followed for an average of 3.5 years, Gardasil was 88 percent effective in the prevention of a combined endpoint of persistent infection, genital warts, vulvar and vaginal precancerous lesions, cervical precancerous lesions, and cervical cancer related to HPV types covered by the vaccine.

"The FDA’s approval of Gardasil 9 in women 27 through 45 years of age is based on these results and new data on long-term follow-up from this study," the FDA said.

Similarly, in men aged 27 through 45 years of age, vaccine effectiveness was inferred based on data described above in women, along with efficacy data of Gardasil 9 in younger men aged 16 through 25 years, and immunogenicity data from a clinical trial in which 150 men, 27 through 45 years of age, received a 3-dose regimen of Gardasil over 6 months.

In all the safety and efficacy of Gardasil 9 was evaluated in a total of 13,000 males and females, the most commonly reported side effect being injection site pain, swelling, redness, and headaches.

The FDA granted the Gardasil 9 application priority review status. This program facilitates and expedites the review of medical products that address a serious or life-threatening condition.

Important Information about GARDASIL 9 (Human Papillomavirus 9-Valent Vaccine, Recombinant)

GARDASIL 9 does not eliminate the necessity for women to continue to undergo recommended cervical cancer screening.

Recipients of GARDASIL 9 should not discontinue anal cancer screening if it has been recommended by a health care provider.

GARDASIL 9 has not been demonstrated to protect against disease from vaccine HPV types to which a person has previously been exposed through sexual activity.

GARDASIL 9 has not been demonstrated to protect against diseases due to HPV types other than 6, 11, 16, 18, 31, 33, 45, 52, and 58.

GARDASIL 9 is not a treatment for external genital lesions; cervical, vulvar, vaginal, and anal cancers; or cervical intraepithelial neoplasia (CIN), vulvar intraepithelial neoplasia (VIN), vaginal intraepithelial neoplasia (VaIN), or anal intraepithelial neoplasia (AIN).

Not all vulvar, vaginal, and anal cancers are caused by HPV, and GARDASIL 9 protects only against those vulvar, vaginal, and anal cancers caused by HPV 16, 18, 31, 33, 45, 52 and 58.

Vaccination with GARDASIL 9 may not result in protection in all vaccine recipients.

FDA press release

Merck news release

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KEYTRUDA gains FDA approval for treatment of recurrent or metastatic cervical cancer

The U.S. Food and Drug Administration (FDA) has approved Merck’s pembrolizumab (KEYTRUDA®), for the treatment of patients with recurrent or metastatic cervical cancer whose disease had worsened on or after chemotherapy and whose tumors express programmed cell death ligand 1 (PD-L1), as determined by an FDA approved test.

The US FDA has approved the Dako PD-L1 IHC 22C3 pharmDx assay for expanded use as a companion diagnostic test for Keytruda for cervical cancer.

The approval comes in way ahead of the previously decided date of June 28. Furthermore, the drug is approved under the FDA’s accelerated approval regulations based on tumor response rate and durability of response.

Continued approval in future will be based upon verification and description of clinical benefit in the ongoing trials ahead.

The accelerated approval was based on results of ongoing KEYNOTE-158, a multi-center, non-randomized, open-label, multi-cohort trial (NCT02628067). The trial enrolled patients with multiple types of advanced solid tumor, who have not responded to usual chemotherapy or are intolerant to it.

Patients with autoimmune diseases or requiring immunosuppression were excluded from the trial.

The patients received KEYTRUDA intravenously at a dose of 200 mg every three weeks until unacceptable toxicity or documented disease progression or for 24 months in patients without disease progression.

Among the 98 patients with advanced cervical cancer, 77 (79%) had tumors that expressed PD-L1 with a Combined Positive Score (CPS) ≥1 and have received at least one line of chemotherapy in the metastatic setting.

The objective response rate in these 77 patients was 14.3 percent, with a complete response in 2 patients (2.6%) and partial response in 9 patients (11.7%).

Ninety-one percent of patients experienced duration of response exceeding 6 months or longer. Eight patients discontinued the drug because of serious side effects like anemia, fistula, hemorrhage, and infection.

The other common side effects of KEYTRUDA are fatigue, musculoskeletal pain, diarrhea, pain and abdominal pain and decreased appetite (21%).

 No responses were observed in patients whose tumors did not have the PD-L1 expression (CPS<1).

KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells. This increases the ability of the body's immune system to help detect and fight tumor cells.

Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories said, “KEYTRUDA is now the first anti-PD-1 therapy approved for the treatment of advanced cervical cancer, providing an important new second-line option for certain patients with this disease. This approval also marks the first indication for KEYTRUDA in gynecologic cancer and reflects our ongoing commitment to bring forward innovative treatment options across a broad range of cancers, including cancers that disproportionately affect women,” in a news release.

KEYTRUDA has already been approved by FDA for treatment of melanoma, head and neck cancer, lung cancer, urothelial cancer, and gastric cancer.

Merck News Release 

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FDA labels Hologic Genius 3D Tomosynthesis Mammography superior for visualization of dense breasts

Hologic, a leading global healthcare and diagnostics company continues to expand its Breast Health portfolio through continued innovation and product development. As a breakthrough, FDA recently approved its Genius 3D Tomosynthesis Mammography as the only test superior to 2D mammography for routine breast cancer screening.

The Genius exams is available to public since 2011, but the newly approved labeling comes in wake of results of clinical studies showing “the exam improves invasive breast cancer detection while reducing unnecessary recalls among women of all breast densities, including those with dense breasts,” according to press release by Hologic.

To find out who offers Genius 3D mammography in your area in USA, click here. 

Among women between the age of 40 to 74 years, nearly 40% to 50% have dense breast. Dense breast also increases the likelihood of developing cancer by 5 to 6 times as compared to women with normal breast density.  Often the cancers are detected very late in women with dense tissue because of imaging difficulty.

Density of breast is a measure of amount of fibrous or glandular tissue in breast and can only be identified by imaging techniques. To make patients aware about it, 31 states in US requires notification to be sent to patients after a mammogram.

"Radiologists and referring physicians needed an answer for how to screen the roughly half of women with dense breasts, because until now, this patient population was confused and frustrated without a clear path forward," said Pete Valenti, Hologic's Division President, Breast and Skeletal Health Solutions. "We are pleased today to provide this definitive guidance from the FDA that the Genius exam is a superior screening solution for women with dense breasts. This is yet another reason referring physicians can feel confident in recommending Hologic's Genius exam."

Although Conventional 2D mammography is currently the gold standard, it has limitations in women with dense breast because the dense tissue can overlay on top of each other and potentially hide small cancers.

The main advantage of 3D tomosynthesis is it can clearly delineate the underlying breast tissue, irrespective of breast density.  This enables the diagnosis at very early stage and reduces false positives results, thereby avoiding unnecessary biopsy.  

It is also a method of choice in women who are at high risk for developing cancer or women who are referred for breast lump.

Another screening modality for women with dense breast is Innovative Breast Ultrasound system: the Invenia Automated Breast Ultrasound System(ABUS).

To get information on personalized breast screening click here 

Here is a video by Hologic about how Genius 3D mammography is performed.

Clarius Wireless, Handheld Ultrasounds receives clearance in Europe.

Clarius probe and smart phone screen 

Clarius wireless ultrasound  gets European CE Mark approval for its wireless C3 and L7 ultrasound scanners.

Mobile Ultrasound developed by Clarius Mobile Health got the FDA 510(k) clearance for its C3 and L7 Clarius wireless ultrasound scanners on December 14, 2016.It has been rated as top technical innovation of 2016, that can change the medical device industry.

Founded in 2014 by Laurent Pelissier, Clarius Mobile Health merges the power of mobile phones, advanced technology, and decades of collective ultrasound experience to produce high quality, point-and-shoot mobile ultrasound devices.

Clarius is based at VANCOUVER, British Columbia.

                                Clarius wireless ultrasound scanners

The device uses just about  any iOS or Android phone or tablet as the display. A Clarius app is used to control the transducers and displaying the visualizations.

Clarius’ultrasound scanners are mobile devices compatible with Apple iOS and Google Android devices, the company said.[i]

The scanners are powered by a rechargeable battery that  will last for more than 45 minutes of scanning and up to 7+ days of stand-by power.

Two batteries and a charger are delivered with each Scanner. Built with a magnesium case, Clarius Scanners are designed to withstand challenging environments and are water submersible for easy cleaning and disinfection.

With automated gain and frequency settings it is as easy to use as a mobile camera.

"Physicians have been asking for a portable ultrasound system that works with their iPhone for some time," said Laurent Pelissier, Chairman and CEO of Clarius Mobile Health.  "The challenge has been to make an affordable device that is small enough to carry around and that also produces great images.  I'm happy to say we've succeeded in creating a product that will enable more clinicians to use ultrasound anywhere to improve patient care. It's as easy to use as a mobile phone camera."

                                     Clarius: The new stethoscope

2016 was the 200th anniversary of the stethoscope and every doctor will eventually hold a hand-held ultrasound that can be used in daily practice, just like a stethoscope  believes Laurent Pelissier, CEO of Clarius.

"Clarius is the future of patient care. The image quality is amazing for any scanner, much less one that fits in my pocket," said Dr. Steven Steinhubl, Director of Digital Medicine at the Scripps Translational Science Institute.  "The ability to wirelessly connect it to any Apple or Android device means that anyone on my team can use it with whatever they already carry around in their pocket."

This mobile ultrasound startup is reshaping the $ 6 billion healthcare market. [ii]

In the United States, Clarius Ultrasound Scanners start at $6900.

Clarius will be available with Color Doppler on its premium offering, which will be priced higher than its entry-level black and white model.

[i] http://www.massdevice.com/clarius-wins-fda-510k-wireless-ultrasound-device/

[ii] http://www.forbes.com/sites/julianmitchell/2016/12/27/this-mobile-ultrasound-startup-is-reshaping-a-6-billion-healthcare-market/#4edb7bda4941

FDA clears marketing of first newborn screening system for detection of four, rare metabolic disorders.

Seeker Instrument 

The U.S.Food and Drug Administration permitted marketing of the Seeker System for the screening of four, rare Lysosomal Storage Disorders (LSDs) in newborns on February 3,2017.[i]

It is the first newborn screening test permitted by FDA to diagnose Mucopolysaxxharidosis type1 (MPS), Gaucher, Pompe and Fabry. These are a group of lysosomal disorders (LSD) and are often under diagnosed because of the multisystem involvement of many organs.

According to the U.S. Department of Health and Human Services’ Advisory Committee on Heritable Disorders in Newborns and Children, MPS I, Pompe, Gaucher and Fabry occur in approximately 1 in 1,500 to no more than 1 in 185,000 newborns and children, depending on the disorder. If not detected and treated in a timely manner, these disorders may cause permanent organ damage, neurological disability or death.

Currently each US state have its own newborn screening program that includes hearing test, screening for congenital heart diseases and endocrinal and metabolic disorders. Several state mandate Lysosomal storage disease screening however, until the Seeker System got clearance there were no FDA-authorized devices for screening of these disorders.

Seeker measures the activity of lysosomal enzymes from newborn dried blood spot specimens collected from heel prick 24-48 hours’ afterbirth. Reduced enzyme activity of these proteins may be indicative of a lysosomal storage disease listed above.

Seeker system received de novo clearance because of its novel technology, low risk  and lack of similar approved device in markets currently. FDA also evaluated data from a clinical study 154,412 newborns in Missouri whose dried blood samples were tested for protein activity associated with MPS I, Pompe, Gaucher and Fabry. The system correctly identified one of each four diseases in the newborns screened, with no false negative results after 15months of follow up.

The Seeker System was created with funding from the Small Business Innovation Research program in National Institutes of Health’s Eunice Kennedy Shriver National Institute of Child Health and Human Development. It is manufactured by Baebies Inc., located in Durham, North Carolina.

Seeker Workstation 

For more information contact:

 Sales Support
+1 (919) 328-8320
info@baebies.com

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[i] http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm539893.htm

YO, a FDA cleared smartphone based app that enables sperm test from comfort of your home.

Courtesy: yospermtest.com

Studies indicate that 30% of infertility cases are related to male reproductive issues. The impact of  being diagnosed as infertile or sub fertile and repeatedly going to pathology lab for tests is like a roller-coaster journey for men. They are often reluctant to get the needed pathological test done, especially the semen analysis.

Medical Electronic System (MES) recently announced the launch of its Yo Home Sperm Test, unsurprisingly the first sperm tester to be powered by a smartphone application.  

MES is a Los Angeles based company specializing in rapid automated sperm analysis systems. All the products are CE and FDA cleared and are sold through extensive worldwide network of   distributors. [1]

The YO Sperm Test uses an app and a detachable mini-microscope "clip" that fits on the top of your I phone or Samsung phone. The device uses phone’s light, focus and recording system.

The testing kit includes everything needed, including the sample collection cup, slide, pipette and liquefying powder.

The patient has to prepare a sample on the slide and insert it into the clip, and in 2 minutes you can actually visualize the motility of sperms on the screen and save the video. The result will be ready in another minute and will be stored in the app along with the video.

Marcia Deutsch, CEO of Medical Electronic Systems says "The technology is able to read the sperm sample 99 percent of the time, as long as the instructions are followed. [If it can read the test] the results are more than 97 percent accurate based on FDA studies of 316 participants."

The tests also report motility according to WHO guidelines of sperm motility as low, moderate or normal. [2]

The YO sperm test does not replace a lab results as it does not give us any idea about sperm morphology. But, it gives 97% accurate results for those who do not want to go to a doctor or lab.

It’s available from the Medical Electronic Systems website, two testing sets come together in a box and will cost $49. It will be available in the market from January 31, 2017.

The other sperm test SpermCheckFertility Home Sperm Test is available in US market since 2012.

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[1] http://www.newswise.com/articles/medical-electronic-systems-announces-the-release-of-the-new-sqa-vision-automated-sperm-quality-analyzer

[2] http://www.aab.org/images/aab/pdf/2014/crbppt14/who.pd