Sunday, 30 September 2018

Euromonitor International: Indonesia´s middle class consumers growing


 
KUALA LUMPUR, Sept 25 (Bernama) -- According to global market research company, Euromonitor International, Indonesia has the largest number of middle class households in ASEAN, representing 30 per cent of households in 2018.

A Euromonitor conference on how companies can tap into the Indonesian market held at Pullman Jakarta Central Park today, also revealed that big cities in Sumatra will have the highest penetration of middle class households by 2030.

“Medan, Bandar Lampung and Padang will be the top three big cities in Indonesia, with almost 50 per cent of its population enjoying annual incomes of between US$10,000 and US$25,000 (US$1 = RM4.13),” said Euromonitor research manager, Adhitya Nugroho, in a statement.

Travel is set to be one of the fastest-growing categories in the country, increasing by 49.2 per cent by 2023.

Led by millennials who are more inclined to splash out on travel than any other demographic, spending on convenience and experience will see unprecedented growth in Indonesia.

Smartphone penetration, which reached 142 per cent of households in 2017, is also supporting the tendency to spend more on holiday-planning.

Euromonitor International is the world’s leading provider for global business intelligence and strategic market analysis.

It has more than 40 years of experience publishing international market reports, business reference books and online databases on consumer markets.

-- BERNAMA

Bombardier gets FAA nod for servicing schedule


KUALA LUMPUR, Sept 25 (Bernama) -- The Federal Aviation Agency (FAA) has granted approval for the maintenance intervals escalation of the CRJ700, CRJ900 and CRJ1000 aircraft.

The line maintenance interval (A-check) is extended to 800 flight hours and the heavy maintenance interval (C-check) to 8,000 flight hours, a statement today said.

“We are thrilled that our operators are benefiting from our continuous improvement mindset as with this evolution, the CRJ Series operators can now take advantage of 14 per cent less maintenance days, meaning more days of revenue flying,” said Bombardier Commercial Aircraft CRJ Series programme head, Charles Comtois.

The maintenance intervals have doubled since the launch of the CRJ aircraft family. The new maintenance intervals are applicable for new production deliveries as well as all CRJ700, CRJ900, and CRJ1000 aircraft in service.

For more information, visit www.bombardier.com.

-- BERNAMA

TIME DOTCOM SELECTS JUNIPER NETWORKS TO POWER VIRTUAL MANAGED SERVICES FOR MALAYSIAN ENTERPRISES

KUALA LUMPUR, Malaysia, Sept 24 (Bernama-GLOBE NEWSWIRE) -- Juniper Networks (NYSE: JNPR), an industry leader in automated, scalable and secure networks, today announced that TIME dotCom Berhad (TIME), a leading communications solutions provider from Malaysia, has used Juniper’s vSRX in rolling out its latest suite of virtual managed services for Malaysian enterprises.

TIME has closely partnered with Juniper Networks for years to deliver broadband connectivity to end users across Malaysia. As businesses increasingly
move workloads into the cloud however, TIME recognized a need to give Malaysian enterprises greater flexibility to easily add, drop or change
services seamlessly through a simple online portal.

To address this industry-wide demand, TIME has introduced two new virtual managed services leveraging Juniper’s vSRX designed to provide end
users with on-demand provisioning – TIME Managed Virtual Router and TIME Managed Virtual Firewall. These services optimize network scalability
and mobility, while reducing the high costs of physical infrastructure.

Through TIME’s new virtual managed cloud services, Malaysian enterprises and their customers are able to implement cost-effective network scalability,
while retaining robust security protection.

Supporting Quotes
“Businesses are increasingly looking to the cloud for their next-generation network, which allows for automated, cost-effective and secure scalability. We are delighted to continue our strong partnership with Juniper Networks, which has allowed us to offer the Malaysian market these new Virtual Managed Services. Our customers no longer need to purchase or maintain costly, physical hardware infrastructure – without having to sacrifice high-performing networking capabilities.”

— Ang Thing Jiun, chief technology officer, TIME dotCom Berhad

“TIME dotCom’s continuous growth, momentum and steady stream of innovative products into the Malaysian market has been nothing
short of impressive. Over the course of our relationship, we have always been excited by TIME’s shared commitment toward removing the constraints and complexities across networking. We are delighted to have been selected for yet another key strategic initiative, this time with Juniper’s vSRX powering their new virtual router and virtual firewall managed services.”

— Ang Thiam Guan, vice president & general manager, Juniper Networks ASEAN

http://mrem.bernama.com/viewsm.php?idm=32771

TOSHIBA LAUNCHES POWER AMPLIFIER FOR CAR AUDIO WITH STRONG RESISTANCE TO POWER SURGES




TOKYO, Sept 25 (Bernama-BUSINESS WIRE) -- Toshiba Electronic Devices & Storage Corporation has launched a new 4-channel power amplifier for car audio, "TCB503HQ” that delivers strong resistance to power surges. Sample shipments start today with mass production scheduled to begin in the first quarter of 2019.
This press release features multimedia. View the full release here:https://www.businesswire.com/news/home/20180924006129/en/ 


Building on Toshiba’s proven development capabilities in ICs for car audio, the new product achieves a higher reliability with an analog fine process resistant to power surges. It also supports 6V operations suitable for vehicles equipped with idling reduction systems, which have become popular in recent years. This feature suppresses popping sounds that occur when power voltage fluctuates.

Other features include a built-in filter to improve resistance to extraneous high-frequency noise, and to prevent generation of abnormal noise even when there is high-frequency noise from mobile phone radio waves and adjustment of door mirrors.

Using the clip detection signal to control the volume and tone control circuit, the sound quality of the set can be improved.
Main specifications
Part numberTCB503HQ
Maximum output50Wx4ch (Vcc=15.2V, RL=4Ω, JEITA max)
Supply voltage6V to 18V
Output offset voltage70mV
Output noise voltage45μV (BW=A-weight)
Functions and features• High output power and low distortion
• Built-in mute and standby functions, offset detection, short circuit detection, and output clip detection
• 6V operations (engine idling reduction capability)
• Built-in protection circuits (overheat, overvoltage, short to the power supply, short to the ground, and load shorted)
PackageHZIP25-P-1.00F
Sample price
(tax included)
500 yen
For further information about the new product, please visit:
https://toshiba.semicon-storage.com/ap-en/product/assp/audio-ic/detail.TCB503HQ.html

Customer Inquiries
Mixed Signal IC Sales and Marketing Department
Tel: +81-44-548-2876
https://toshiba.semicon-storage.com/ap-en/contact.html

Information in this document, including product prices and specifications, content of services and contact information, is current on the date of the announcement but is subject to change without prior notice.

About Toshiba Electronic Devices & Storage Corporation

Toshiba Electronic Devices & Storage Corporation combines the vigor of a new company with the wisdom of experience. Since becoming an independent company in July 2017, we have taken our place among the leading general devices companies, and offer our customers and business partners outstanding solutions in discrete semiconductors, system LSIs and HDD.

Our 19,000 employees around the world share a determination to maximize the value of our products, and emphasize close collaboration with customers to promote co-creation of value and new markets. We look forward to building on annual sales now surpassing 700-billion yen (US$6 billion) and to contributing to a better future for people everywhere.

Find out more about us at https://toshiba.semicon-storage.com/ap-en/company.html

View source version on businesswire.com: https://www.businesswire.com/news/home/20180924006129/en/ 


Contact
Media Inquiries:
Toshiba Electronic Devices & Storage Corporation
Chiaki Nagasawa, +81-3-3457-4963
Digital Marketing Department
semicon-NR-mailbox@ml.toshiba.co.jp

Source : Toshiba Electronic Devices & Storage Corporation

--BERNAMA

NEXTDECADE RECEIVES FERC SCHEDULING NOTICE FOR RIO GRANDE LNG

THE WOODLANDS, Texas, Sept 5 (Bernama-BUSINESS WIRE) -- NextDecade Corporation (“NextDecade”) (NASDAQ: NEXT) announced today that the Federal Energy Regulatory Commission (“FERC”) has issued a notice of schedule for environmental review of NextDecade’s Rio Grande LNG project in South Texas, as well as the associated Rio Bravo Pipeline to originate in the Agua Dulce area.

According to the notice, FERC will issue its final Environmental Impact Statement (EIS) on April 26, 2019, based on issuance of a draft EIS in October 2018. FERC has established a 90-day Federal Authorization Decision Deadline on July 25, 2019.

Assuming a favorable FERC order, NextDecade anticipates a final investment decision on the project in 3Q 2019.

Rio Grande LNG and Rio Bravo Pipeline regulatory timeline
Section 3(a) & 7(c) FERC ApplicationMay 5, 2016
Draft Environmental Impact StatementOctober 2018
Final Environmental Impact StatementApril 26, 2019
Federal Authorization Decision DeadlineJuly 25, 2019
About NextDecade Corporation

NextDecade is an LNG development company focused on LNG export projects and associated pipelines in Texas. NextDecade intends to develop a portfolio of LNG projects, including the 27 mtpa Rio Grande LNG export facility in Brownsville, Texas and the 4.5 Bcf/d Rio Bravo Pipeline that would transport natural gas from the Agua Dulce area to Rio Grande LNG. NextDecade’s common stock is listed on the Nasdaq Capital Market under the symbol “NEXT.” NextDecade is headquartered in The Woodlands, Texas.

Located at the Port of Brownsville in South Texas, NextDecade’s Rio Grande LNG project is expected to be a leader among second wave U.S. LNG projects. NextDecade believes its customers and shareholders will benefit from the project’s experienced leadership, proven approach, and optimal location. NextDecade’s technology selections are expected to foster operational reliability and afford NextDecade’s customers access to reliable, low-cost, abundant natural gas from the Permian Basin, Eagle Ford Shale, and other basins.

Learn more at www.next-decade.com.

CAUTIONARY INFORMATION ABOUT FORWARD-LOOKING STATEMENTS

This press release contains forward-looking statements within the meaning of U.S. federal securities laws. The words “believe,” “expect,” “intend,” “plan,” “potential,” and similar expressions are intended to identify forward-looking statements, and these statements may relate to the business of the Company and its subsidiaries. These statements have been based on the Company’s current assumptions, expectations, and projections about future events and involve a number of known and unknown risks, which may cause actual results to differ materially from expectations expressed or implied in the forward-looking statements. These risks include uncertainties about the Company’s Rio Grande LNG and Rio Bravo pipeline projects and other matters discussed in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the year ended December 31, 2017 and other subsequent reports filed with the Securities and Exchange Commission, all of which are incorporated herein by reference.

Any development of the projects remain contingent upon completing required commercial agreements; acquiring all necessary permits and approvals; securing all financing commitments and potential tax incentives; achieving other customary conditions; and making a final investment decision to proceed. The forward-looking statements in this press release speak as of the date of this release. Although the Company believes that the expectations reflected in these forward-looking statements are reasonable, the Company can give no assurance that the expectations will prove to be correct. The Company may from time to time voluntarily update its prior forward-looking statements, however, it disclaims any commitment to do so except as required by securities laws.

View source version on businesswire.com: https://www.businesswire.com/news/home/20180904005211/en/ 



Contact
NextDecade
Investors:
Patrick Hughes
+1 (832) 209-8131
phughes@next-decade.com
or
Media:
Ashley Helmer
+1 (281) 249-5453
ahelmer@next-decade.com

Source : NextDecade Corporation

--BERNAMA

Friday, 28 September 2018

A.M. BEST ASSIGNS CREDIT RATINGS TO PETROLIMEX INSURANCE CORPORATION

SINGAPORE, Sept 28 (Bernama-BUSINESS WIRE) -- A.M. Best has assigned a Financial Strength Rating of B+ (Good) and a Long-Term Issuer Credit Rating of “bbb-” to Petrolimex Insurance Corporation (PJICO) (Vietnam). The outlook assigned to these Credit Ratings (ratings) is stable.

PJICO’s two largest shareholders are Vietnam National Petroleum Corporation (Petrolimex) (41% ownership) and Samsung Fire & Marine Insurance Co, Ltd. (20% ownership) (SFM). Petrolimex is the biggest domestic petro-oil distributor in Vietnam and one of the largest state-owned enterprises there. SFM is the leading non-life insurer in South Korea.

The ratings reflect PJICO’s balance sheet strength, which A.M. Best categorizes as strong, as well as its adequate operating performance, neutral business profile and appropriate enterprise risk management.

PJICO’s risk-adjusted capitalization, as measured by Best’s Capital Adequacy Ratio (BCAR), is supported by a conservative and highly liquid investment portfolio, which is composed of mainly cash and bank deposits. Prospectively, A.M. Best expects PJICO’s BCAR ratios to remain supportive of its strong balance sheet assessment, despite being on a declining trend.

PJICO was the fifth-largest player in Vietnam’s non-life market in 2017 with a 6.5% market share. The affiliation with Petrolimex has provided PJICO with access to favorable cargo business, which has contributed significantly to the company’s underwriting performance. In addition, PJICO is leveraging Petrolimex’s countrywide network of more than 2,500 petrol stations to distribute retail insurance products.

An offsetting rating factor is a trend of reduced underwriting margins as a result of intensifying market competition in the motor and health segments. The company has achieved overall profitability for five years, but it has relied largely on the cargo business (10% of group premium written) and interest income to offset the weakening performance in other major lines of business.

The company is well-positioned at the current rating. Negative rating actions could occur if the operating performance weakens materially.

Ratings are communicated to rated entities prior to publication. Unless stated otherwise, the ratings were not amended subsequent to that communication.

This press release relates to Credit Ratings that have been published on A.M. Best’s website. For all rating information relating to the release and pertinent disclosures, including details of the office responsible for issuing each of the individual ratings referenced in this release, please see A.M. Best’s Recent Rating Activity web page. For additional information regarding the use and limitations of Credit Rating opinions, please view Understanding Best’s Credit Ratings. For information on the proper media use of Best’s Credit Ratings and A.M. Best press releases, please view Guide for Media - Proper Use of Best’s Credit Ratings and A.M. Best Rating Action Press Releases.

A.M. Best is a global rating agency and information provider with a unique focus on the insurance industry. Visit www.ambest.com for more information.

Copyright © 2018 by A.M. Best Rating Services, Inc. and/or its affiliates. ALL RIGHTS RESERVED.

View source version on businesswire.com:
https://www.businesswire.com/news/home/20180927005730/en/


Contact

A.M. Best
Tran Nhat Trung, +65 6303 5019
Financial Analyst
trung.tran@ambest.com
or
Chi Yeung Lok, +65 6303 5016
Director, Analytics
chi-yeung.lok@ambest.com
or
Christopher Sharkey, +1 908 439 2200, ext. 5159
Manager, Public Relations
christopher.sharkey@ambest.com
or
Jim Peavy, +1 908 439 2200, ext. 5644
Director, Public Relations
james.peavy@ambest.com

Source : A.M. Best

PURECIRCLE AND NORTH CAROLINA FARMERS SOON HARVEST COMPANY'S FIRST COMMERCIAL STARLEAFTM STEVIA CROP GROWN IN THE U.S.

Follows Successful Growing Season With Partner Farmers
 
CHICAGO, Sept 28 (Bernama-GLOBE NEWSWIRE) -- PureCircle (LSE: PURE), the world’s leading producer and innovator of stevia sweeteners, and its North Carolina farmer partners are about to harvest the company’s  first commercial-scale crop of Starleaf™ stevia grown in the U.S.  PureCircle’s proprietary Starleaf stevia contains more of the best-tasting stevia sweeteners, such as Reb M, than other stevia plant variants.  Fortunately, the North Carolina farms growing the Starleaf stevia plants were not damaged by Hurricane Florence which tragically ravaged some areas of the Carolinas.

Following successful Starleaf stevia plot trials in North Carolina in 2017, PureCircle and a number of farmers in the state increased the amount of acreage dedicated to stevia by tenfold this year.  The quality and yield of that Starleaf stevia met PureCircle’s standards.  As a result, PureCircle plans to increase significantly the acreage used to grow stevia in the U.S. over the next two to three years.

The North Carolina program is enabling PureCircle to broaden and diversify its supply chain by increasing the amount of Starleaf stevia grown in different areas around the globe and throughout the year. This gives food and beverage companies further confidence to launch global brands with PureCircle’s best-tasting stevia leaf sweeteners like Reb M.

The North Carolina farming partnerships have provided innovations for both PureCircle and the farmers. The work in North Carolina has yielded advances for the company’s stevia agronomy program, including how to adapt growing stevia plants to different regions of the world. In addition, the mechanization of farming – and advances from this program – are particularly important in North Carolina to maintain a sustainable economic crop.

PureCircle’s North Carolina farming partnerships are also helping farmers productively and profitably utilize acreage that once grew tobacco.

Commenting on the North Carolina Stevia farming initiative, PureCircle CEO Maga Malsagov said:

“Our partnerships in North Carolina will significantly increase our supply of Starleaf stevia plants grown in North America and thereby geographically diversify our stevia plant supply. We plan to increase the North Carolina program next year and again in future years.  We currently have three strong farming partnerships in North Carolina, and we expect to bring many more farmers into our program.”  He added: “We could not be more pleased with this year’s results.”

PureCircle recently announced advances which enable it to supply significantly more Reb M for the food and beverage industry. The Company produces Reb M both directly from Starleaf stevia plants, like the ones being grown in North Carolina, and from other stevia sweeteners in the plants.  In the latter case, PureCircle starts with purified stevia leaf extract with low Reb M content and by adding an enzyme, the maturation to Reb M is completed just as the leaf does itself.

The recent advances now enable PureCircle to significantly boost production of the stevia sweeteners which have the most sugar-like taste and which are most sought after by beverage and food companies.  PureCircle’s two-front innovation enables the company to provide its best-tasting stevia sweeteners in significant quantities and cost effectively for its customers.

As the result of its innovation, research and development work with stevia, PureCircle has been granted an array of stevia-related patents.  These patents – plus additional applied for patents — cover a wide range of stevia-related products and processes which play a role across PureCircle’s vertically integrated supply chain.

For more information on PureCircle's North Carolina farming partnerships, please see: https://youtu.be/dnb3uS3JpMo

For more information on PureCircle, please see: www.purecircle.com

Media may direct inquiries to:

Carolyn Clark, Director of Global Marketing 
Email:  carolyn.clark@purecircle.com  Phone: 1 (630) 517 0812
 
Jackson Pillow, Media Relations Manager
Email:  Jackson.Pillow@purecircle.com  Phone: +1 630 256 8394
 
About PureCircle
  • PureCircle combines advanced R&D with full vertical integration from farm to high-quality, great-tasting innovative stevia sweeteners.
  • The Company collaborates with farmers who grow the stevia plants and with food and beverage companies which seek to improve their low- and no-calorie formulations using a sweetener from plants.
  • PureCircle will continue to: lead in research, development and innovation; produce a growing supply of multiple varieties of stevia sweeteners with sugar-like taste, using all necessary and appropriate methods of production; and be a resource and innovation partner for food and beverage companies.
  • PureCircle stevia flavor modifiers work in synergy with sweeteners to improve the taste, mouthfeel and calorie profile, and enhance the cost effectiveness, of beverage and food products.
  • Founded in 2002, PureCircle is continually investing in breakthrough research and development and it currently has more than 100 stevia-related granted patents and more than 250 patents pending globally.
  • PureCircle has offices around the world with the global headquarters in Chicago, Illinois.
  • To meet growing demand for stevia sweeteners, PureCircle is rapidly ramping up its supply capability. It completed expansion of its Malaysian stevia extract facility in March 2017, increasing its capacity to rapidly supply the newer and great-tasting stevia sweeteners and helping provide ever-increasing value to its customers.
  • PureCircle's shares are listed on the main market of the London Stock Exchange.
  • For more information, visit: www.purecircle.com 
 
About stevia
  • Given the growing global concerns about obesity and diabetes, beverage and food companies are working responsibly to reduce sugar and calories in their products, responding to both consumers and health and wellness advocates. Sweeteners from the stevia plant offer sugar-like taste and are becoming an increasingly important tool for these companies.
  • Like sugar, stevia sweeteners are from plants. But unlike sugar, they enable low-calorie and zero-calorie formulations of beverages and foods.
  • Stevia leaf extract is a natural, zero calorie, high-intensity sweetener, used by global food and beverage companies as a great-tasting zero-calorie alternative to sugar and artificial sweeteners.
  • Stevia is a naturally sweet plant native to South America; today, it is grown around the world, notably in Kenya, China and the US.
  • The sweet-tasting parts of the stevia leaf are up to 400 times sweeter than sugar: stevia's high-intensity sweetness means it requires far less water and land than sugar.
  • Research has shown that the molecules of the stevia leaf are present and unchanged in the dried stevia leaf, through the commercial extraction and purification process, and in the final stevia leaf extract product. Many major global regulatory organisations, across 65 countries, have approved the use of high-purity stevia leaf extracts in food and beverages.
  • For more information on the science of stevia, please visit https://www.purecirclesteviainstitute.com/

China´s Shandong invites overseas Chinese students to start business


KUALA LUMPUR, Sept 28 (Bernama) -- Shandong - a coastal province in eastern China - is welcoming overseas-educated Chinese students home to start their own businesses.

Governor of Shandong, Gong Zheng in his invitation said Shandong - with 145 universities and colleges -- firmly believes that while development is the top priority, talents are the most important resources and innovation is the premier driving force.

To attract more overseas-educated scholars to Shandong, the 10th China Shandong Domestic and Overseas High-end Talents Exchange Fair is slated on 29 to 31 October in Weihai, Shandong.The fair has been held for 9 sessions in a row, a statement said.

With themed "Gathering global talents, promoting quality development", the fair is expected to be a diversified, specialized and well-targeted international event that encompasses factors including talents, ideas, projects, technologies and financial capital.

“We work unremittingly to improve the policies for recruitment, training and use of talents, and upgrade the relevant mechanism and institution so that Shandong can become a fertile ground for talents,” he said in the invitation.

As a platform connecting Shandong with domestic and overseas high-caliber professionals and projects, the event offers an important opportunity for talents across the world to get to know, come and participate in the development of the province.

Shandong is also expected to set an example for rural revitalization, give higher priority to marine industry, and serve as a powerhouse for opening up. Acting upon the important instructions of Chinese General Secretary Xi, Shandong is implementing the major program to foster new drivers of growth and build a modernized economic system with focus on high quality development and supply-side structural reform.

Shandong accounts for nearly 1/10 of the GDP, 1/8 of the industrial output and 1/4 of the agricultural export of China.

In 2017, the GDP of Shandong reached 7.27 trillion yuan; general budget revenue topped 600 billion yuan; foreign trade was nearly 1 trillion yuan; the number of market entities exceeded 8 million. (1 yuan = RM0.60)

--BERNAMA

MFPC honoured in Islamic Wealth Management at awards event, Sarajevo

KUALA LUMPUR, Sept 28 (Bernama) -- The Malaysian Financial Planning Council (MFPC) won the award in the Best Islamic Wealth Management Qualification category at the Global Islamic Finance Awards (GIFA) 2018, held in Sarajevo, Bosnia recently.

In its eighth year, the awards ceremony was officiated by President of Bosnia, Bakir Izetbegovic.

MFPC president, Michael Kok Fook On said: “It is a great honour to receive the Best Islamic Wealth Management Qualification 2018 for Shariah Registered Financial Planner. It goes to show our commitment in ensuring that the best quality of our programme is retained.

“To date, the council has partnered with various reputable international organisations in order to provide good financial planning education which is aligned with the Sustainable Development Goals (SDGs), SDG 4 and SDG 17. We hope the award can encourage us to promote the concepts of shariah financial planning to a wider pool of Malaysians.”

 MFPC has developed Shariah Registered Financial Planner as a practical programme for practitioners to equip themselves with takaful and Islamic financial planning knowledge in line with the national agenda to promote its advancement.

It is also to make Malaysia the Islamic financial centre in transactions and business based on shariah compliance.

-- BERNAMA

INVIVOSCRIBE® RECEIVES APPROVAL IN JAPAN FOR ITS LEUKOSTRAT® CDX FLT3 MUTATION ASSAY TO ASSESS ACUTE MYELOID LEUKEMIA (AML) PATIENTS ELIGIBLE FOR TREATMENT WITH XOSPATA® (GILTERITINIB FUMARATE)

SAN DIEGO, Sept 28 (Bernama-GLOBE NEWSWIRE) -- Invivoscribe® Inc., a global company providing biomarker and clonality test solutions for the fields of oncology and personalized molecular medicine® today announces Pharmaceuticals and Medical Devices Agency (PMDA) approval of the LeukoStrat CDx FLT3 Mutation Assay companion diagnostic.

As the first company to receive both FDA and PMDA approval for an acute myeloid leukemia (AML) companion diagnostic, Invivoscribe continues our mission for global standardization of diagnostic testing and expanding our global laboratory network.

The LeukoStrat CDx FLT3 Mutation Assay is a PCR-based in vitro diagnostic test designed to detect internal tandem duplications (ITD) and tyrosine kinase domain (TKD) mutations D835 and I836 in the FLT3 gene. The globally standardized test includes software that interprets data, generates mutant/wildtype signal ratios for ITD and TKD mutations, and predicts response to gilteritinib fumarate.

Invivoscribe developed this companion diagnostic as an aid in identifying FLT3 mut+ AML patients eligible for treatment with gilteritinib fumarate (Xospata®). FLT3 somatic variants are among the most common driver mutations with the strongest effects on the overall survival in acute myeloid leukemia1. This companion diagnostic screened subjects for enrollment eligibility into the Phase 3 ADMIRAL study evaluating gilteritinib fumarate for the treatment of FLT3 mutation-positive (FLT3 mut+) relapsed or refractory AML adult patients.

The LeukoStrat CDx FLT3 Mutation Assay is available as a commercial service offering from LabPMM GK in Japan to identify FLT3 mut+ AML patients for possible Xospata® treatment.  Distributable LeukoStrat CDx FLT3 Mutation Assay Kits are expected to begin shipment from LabPMM GK, the Marketing Authorization Holder (MAH) in Japan, in late 2018. 

“Invivoscribe has long been committed to international standardization of molecular diagnostic tests. Test standardization is a critical part of precision medicine as it helps to refine treatments and accelerate drug approvals. Approval of our LeukoStrat CDx FLT3 Mutation Assay in Japan follows on the approval of the same test by the FDA in the US last year. These milestones represent a significant step towards standardized detection of one of the most important driver mutations in AML.”, said Jeffrey Miller, CSO & CEO of Invivoscribe.

Invivoscribe is a privately held biotechnology company dedicated to improving the quality of healthcare worldwide by providing high quality, standardized reagents, tests, and bioinformatics tools to advance the field of precision medicine. Invivoscribe has a successful track record of partnerships with global pharmaceutical companies interested in developing and commercializing companion diagnostics. LabPMM GK is an accredited subsidiary of Invivoscribe. 

For additional information please contact LabPMM GK at support@labpmm.com or visit www.invivoscribe.com/clinical-services.

1) Papaemmanuil E, Gerstung M, Bullinger L, et al. N Engl J Med 2016; 374(23):2209-2221

SOURCE : Invivoscribe, Inc.